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Production
- Unit Operations|
  Novartis operations head resigns, ops division splits
  
  Novartis’ operations president, Andre Wyss, is leaving the company, where he was responsible for streamlining production and corporate services.
  
  Novartis’ operations president, Andre Wyss, is leaving the company, where he was responsible for streamlining production and corporate services. According to the drugmaker, Wyss has decided to step down from the Executive Committee of Novartis on April 1, 2018, to pursue his career outside of Novartis. As a result, Novartis Operations will be split into Novartis Technical Operations and Novartis Business Services. Steffen Lang, Global Head Novartis Technical Operations, will report directly to the CEO and become art of the Executive Committee of Novartis. Philippe Barrois, Head Novartis Corporate Affairs, will lead the Novartis Business Services organization ad interim while the company searches for a new Head of Novartis Business…
  Full Story
  
  Recent
  
  Cutting-Edge Flexibility
  
  Trailblazing Women in Pharma History
  
  Augmenting our Ability to Succeed
  
  The State of Pharma in Trump’s Union
- Aseptic Processing|
  Novartis sells injectables plant to Avara
  
  Novartis announced the sale of its Quebec sterile manufacturing facility as well as the adjacent Sandoz Development Center to CDMO Avara Pharmaceutical Services.
  
  Novartis announced the sale of its Quebec sterile manufacturing facility as well as the adjacent Sandoz Development Center to CDMO Avara Pharmaceutical Services. The Boucherville plant is the largest sterile manufacturing facility for injectable medicines in Canada, supplying injectable medicines to Sandoz in Canada and the United States. Under the terms of the deal, Sandoz Canada remains the owner of the marketing authorizations for its products manufactured by Avara, and both parties will sign a long-term supply agreement to ensure that supply, quality and service remains unchanged. For Avara, the acquisition represents its first entry into the Canadian market and further expands its sterile processing capability.
  Full Story
  
  Recent
  
  Sizing Up the Benefits of Sterile Drug Manufacturing Techniques
  
  Maximum and Minimum Loads in Steam Sterilization
  
  Transforming Bioburden Risk with Digital Asset Intelligence
  
  Contorting Convention
- Op Ex & Lean Six Sigma|
  OEE Overview
  
  Industry experts weigh in on the application and value of Overall Equipment Effectiveness in pharma
  
  Pharmaceutical manufacturers continually strive to improve the quality of their products along with improving their production operations. Over the years, many manufacturers empowered their workforce to follow the management techniques of Six Sigma — the statistical-based, data-driven method to reduce costs and increase profits, and Kaizen — the gradual and methodical process to boost productivity by improving the work environment. These initiatives can bring improvements to an operation as long as the manufacturer has a structured means of measuring the results by hour, shift, day, week and so on. One such key performance indicator, or KPI, is Overall Equipment Effectiveness (OEE). OEE is a measure of how effectively a manufacturing…
  Full Story
  
  Recent
  
  Lean Laggards: Exploring the State of Lean in Pharma
  
  Mature Quality Systems: What Pharma Can Learn from Other Industries
  
  Integrated Continuous Manufacturing
  
  Implementing Risk-Based Validation Team-by-Team
- Automation & Control|
  Making the Case for Wireless on the Production Floor
  
  How WirelessHART devices and networks can cost-effectively improve operations by delivering critical data
  
  Pharmaceutical manufacturing plants, both full-scale production facilities and laboratories, are generally networked using IT platforms such as Ethernet and Wi-Fi. These are essentially office networks that have been extended into manufacturing environments to serve a variety of functions, but were not designed with manufacturing support as their primary purpose.In contrast, HART and WirelessHART were designed for process manufacturing applications, and are thus better networking protocols for instrumentation and device-level communication. Both networks are supported by the independent FieldComm Group, with hundreds of member companies.Manufacturers considering ways to improve communication and process data capture within production units…
  Full Story
  
  Recent
  
  For Industry-Wide Digitalization, Think Small
  
  A Better Batch
  
  OEE Overview
  
  Atrium Innovations Modernizes Quality Management
- Packaging|
  Bayer recalls Alka-Seltzer due to packaging issues (again)
  
  Bayer is voluntarily recalling Alka-Seltzer Plus packages that were sold in the U.S. at Walmart, CVS, Walgreens and Kroger after February 9, 2018, due to a labelling error.
  
  Bayer is voluntarily recalling Alka-Seltzer Plus packages that were sold in the U.S. at Walmart, CVS, Walgreens and Kroger after February 9, 2018, due to a labeling error. The ingredients listed on the front sticker of the carton may potentially be different from the ingredients listed on the back of the carton. This is the second Alka-Seltzer recall in less than a year for Bayer. In August of 2017, Bayer issued a voluntary Class II recall of more than one million cartons of Alka-Seltzer due to confirmed customer compliants of small holes or cracks in the foil of blister packs. The recalled Alka-Seltzer was manufactured at a German plant. Bayer has not confirmed the number of packages affected by this most recent recall. Read the FDA…
  Full Story
  
  Recent
  
  EU FMD: The One-Year Countdown
  
  FDA Warns Guangdong for API Label Mix-Up
  
  State of Packaging in the Pharma Industry
  
  Finding New Roads
- Batch|
  Personalization Status: It’s Complicated
  
  In the 10 days following the news about Facebook’s data privacy breach involving political consultancy, Cambridge Analytica, Facebook shares dropped almost 18 percent.This was a prime example of consumers’ love/hate relationship with personalization. On the one hand, we’ve come to expect that marketers know us and what we want. We no longer have the patience to sift through information that isn’t relevant to our interests.In this regard, personalization has made life exponentially more efficient. But reducing the amount of time spent sifting through non-targeted marketing adds an additional layer of complexity further down the chain. When it comes to personalized marketing, this complexity comes in the form of data privacy…
  Full Story
  
  Recent
  
  Why Cookies Crumble
  
  A Better Batch
  
  Contorting Convention
  
  Ensuring Batch-to-Batch Repeatability in Sanitary Processes
- Continuous|
  A Better Batch
  
  Today’s solid dose manufacturing reality still relies on skillful execution by operators
  
  "If I sent everyone in this class home with the same recipe for cookies, would all the cookies taste the same?” asked solid dose expert, Mike Tousey, during his recent Techceuticals “Manufacturing Process” training course. Knowing my own habit of carelessly mixing ingredients to the point where they actually take flight out of the bowl, I immediately knew the answer here was “no.” The reality is, even if everyone follows the same recipe, variables in environment, ingredients, equipment and skill still exist. While cookie individuality isn’t always a bad thing, when it comes to solid dose manufacturing, the goal is consistent, reproducible results. After decades spent perfecting the craft of tablet making, manufactures (and…
  Full Story
  
  Recent
  
  Cutting-Edge Flexibility
  
  Driving Bioprocessing Efficiency
  
  True Continuous Manufacturing
  
  STEERLife Collaborates with Ole Miss on Drug Development and Manufacturing Research
- PAT|
  The Role of Mechanistic Understanding in QbD
  
  The integration of scientific rationale supports the probabilistic modeling approach that is required for effective QbD implementation
  
  Historically, pharmaceutical manufacturing has been associated with certain challenges. With traditional manufacturing, the pharma industry has been able to achieve a desired product quality but is associated with excessive costs, high waste, rejections and delays. Additionally, it lacks thorough understanding of the products and processes and proactive characterization of the failures. A thorough understanding of the drug product/processes will ensure robust and consistent quality. The U.S. Food and Drug Administration has given its guidance in 2004 to solve these issues under QbD.1 Implementing Quality by Design tools will help to alleviate the rejections, prevent the delays and reduce the associated costs. QbD is a disciplined and…
  Full Story
  
  Recent
  
  Purdue research hub looks to make lyophilization obsolete
  
  PAT for High Shear Wet Granulation Monitoring and Control
  
  Product Focus: Process Analytical Technologies
  
  Henry Ford Had It Right
- Fluid
  Pressure Regulating Valve Family
  
  Full Name: Pressure Regulating Valve Family Team: GF Piping SystemsStatus: Elastomer Free Debut: January 2015 Field Position: High purity piping systems Skill Set: Engineered modular design and materials eliminate particle shedding Performance Stats:• Elastomer-free proprietary piston design• Modular design and cartridge makes valve function switches easier• Central housing nut does away with re-torqueing Regulatory Profile: Suitable for high-purity system duty and GMP-based processing. Coach’s Notes: “Our new Pressure Regulating Valve family offers solutions that no one else in the PRV market offers,” says Jeff Sixsmith, Product Manager for Valves and Actuation for GF Piping Systems. “The piston design…
  Full Story
  
  Recent
  
  AdvantaPass
  
  Pall Life Sciences Wins Interphex Best-in-Show Distinction
  
  Process Cooling as Part of a Sustainable Strategy
  
  Applying Single-Use Efficiencies to Room-to-Room Fluid Transfer
Development
- Analytics|
  The Quest for Data
  
  How Bristol-Myers Squibb used advanced tools to find and utilize the right data
  
  Digitization offers the promise to connect everything on the plant floor. The emerging smart, connected plant will have an immense impact on production efficiency, but will also bring challenges. These include storing, capturing, contextualizing, visualizing and analyzing the tremendous volumes of data. Without appropriate contextualization, visualization and analysis, it would be very difficult indeed for employees to make sense of that data and use it in applications to improve quality, prevent abnormal behavior, and/or manage assets better. Manufacturers often struggle with leveraging the massive amounts of production data they collect to improve production efficiencies. This is particularly true in the data-intensive pharmaceutical and…
  Full Story
  
  Recent
  
  Leveraging Platform Analytical Methods for Biopharma QbD
  
  Toward Zero Defects: Using Analytics to Reshape Quality
  
  Unlocking the Competitive Edge with Integrated Informatics
  
  Creating Value from Data Assets
- Modeling |
  The Role of Mechanistic Understanding in QbD
  
  The integration of scientific rationale supports the probabilistic modeling approach that is required for effective QbD implementation
  
  Historically, pharmaceutical manufacturing has been associated with certain challenges. With traditional manufacturing, the pharma industry has been able to achieve a desired product quality but is associated with excessive costs, high waste, rejections and delays. Additionally, it lacks thorough understanding of the products and processes and proactive characterization of the failures. A thorough understanding of the drug product/processes will ensure robust and consistent quality. The U.S. Food and Drug Administration has given its guidance in 2004 to solve these issues under QbD.1 Implementing Quality by Design tools will help to alleviate the rejections, prevent the delays and reduce the associated costs. QbD is a disciplined and…
  Full Story
  
  Recent
  
  ACEA Biosciences Introduces "Fail it Fast" Assay Technology
  
  Advanced Analytics Improve Biopharma Operations
  
  Archived Webinar: QbD Development of a Purity Method Using UPLC and Mass Detection
  
  Biopharmaceutical Process Control: Part Two: Process Modeling
- Drug Delivery|
  Recipharm to buy Sanofi contract business, plant
  
  Swedish CDMO, Recipharm, has struck a deal with Sanofi to buy the French drugmaker’s contract inhalation drug business and plant in the U.K.
  
  Swedish CDMO, Recipharm, has struck a deal with Sanofi to buy the French drugmaker’s contract inhalation drug business and plant in the U.K.Sanofi's Holmes Chapel manufacturing facility is a leading contract manufacturing site in Europe and is home to a team of more than 450 specialist employees. All employees will automatically transfer to Recipharm.Recipharm will pay about £45 million ($60.2 million) for the 125,000-square meter site near Manchester.Read the press release
  Full Story
  
  Recent
  
  J&J to Close Diabetes Unit
  
  FDA Says Pfizer Failed to Investigate EpiPen Failures
  
  Trends in Excipient Demand
  
  The Case for On-Dose Authentication
- QbD|
  The Role of Mechanistic Understanding in QbD
  
  The integration of scientific rationale supports the probabilistic modeling approach that is required for effective QbD implementation
  
  Historically, pharmaceutical manufacturing has been associated with certain challenges. With traditional manufacturing, the pharma industry has been able to achieve a desired product quality but is associated with excessive costs, high waste, rejections and delays. Additionally, it lacks thorough understanding of the products and processes and proactive characterization of the failures. A thorough understanding of the drug product/processes will ensure robust and consistent quality. The U.S. Food and Drug Administration has given its guidance in 2004 to solve these issues under QbD.1 Implementing Quality by Design tools will help to alleviate the rejections, prevent the delays and reduce the associated costs. QbD is a disciplined and…
  Full Story
  
  Recent
  
  Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory Framework
  
  Product Focus: Process Analytical Technologies
  
  Leveraging Platform Analytical Methods for Biopharma QbD
  
  Evolution of Inhalation Drug Delivery
- Product/Process Development
  Differential Scanning Calorimetry Finds a Place in Manufacturing
  
  Advances in DSC deliver end-to-end stability characterization for biopharmaceutical development through to manufacturing
  
  The stability of a protein is one of the critical factors influencing its safety and efficacy as a potential biotherapeutic. Consequently, a variety of analytical techniques are deployed in determining and monitoring protein stability throughout biopharma development and production processes. Of these, differential scanning calorimetry (DSC) has long played a role in preformulation development. Now, DSC is expanding into the manufacturing environment, offering significant gains in productivity. This article looks at the technique’s contribution to biopharma development and explores the advances in technology and regulatory compliance that are facilitating its migration into the manufacturing space. Differential scanning calorimetry (DSC)…
  Full Story
  
  Recent
  
  The Rise of Hazard Chemistry in Drug Development
  
  Novartis buys gene therapy co. for $8.7B
  
  Stem Cell Therapy: Resolving the Mismatch
  
  Alzheimer's blood test shows promise
Information Technology
- IT Management |
  Digital Transformation Facilitates On-Time Delivery
  
  Digital transformation has become a critical imperative to address the weak link of ATP/CTP in the pharma supply chain
  
  Promise dates for delivery of drugs to pharmacies and healthcare providers have traditionally been little more than guesswork. The problem is only worsening as pharmaceutical manufacturers struggle with growing complexity across a highly volatile global supply chain. The stakes are high. Pharmaceutical companies suffer lost revenue and dissatisfaction among healthcare provider customers when drugs aren’t delivered on time and in full. Revenue drops if a healthcare provider turns instead to a competitor or generic drugs. More importantly, patient health can be jeopardized if promise dates aren’t met, leaving a hospital or an entire region without needed medication. Pharmaceutical companies are acutely aware of the limitations of…
  Full Story
  
  Recent
  
  Improving Digital Quality in the Pharmaceutical Industry
  
  Achieving Real-Time Results Without Infrastructure Investments
  
  Industrial Cybersecurity Defenses Essential for Pharma Companies
  
  Automating Decision-Making in Pharma
- Production/Manufacturing|
  Augmenting our Ability to Succeed
  
  Creating a synergistic relationship between humans and technology yields greater productivity, control and reliability in a workspace
  
  So a guy walks into a suite and pulls the sparger out of what he thinks is an empty bioreactor and ends up dumping a $3 million-batch of biologics on the floor—oops. No, this isn’t the start of a bad pharma joke, this is a real story I heard from a customer in the industry, which completely changed the way I thought about how humans operate in complex, compliance-driven environments. With the right technology, that man could have avoided making that mistake, or others, at work. It is my firm belief that the combination of humans and technology yields greater productivity, control and reliability in a workspace than if each entity operates independently. This is especially true for the pharma and biotech industries in which you have…
  Full Story
  
  Recent
  
  Are You Using EBR to Its Full Potential?
  
  Product Focus: Downstream Bioprocessing Trends
  
  Degrees of Digitalization
  
  4 Steps for Managing Biopharmaceutical Projects
- Quality/Compliance|
  The Evolution of Quality
  
  Why good quality doesn't have to mean higher costs — in fact, it often means lower recall and warranty costs
  
  Disaster has a way of concentrating the mind. Massive recalls and lawsuits — over luxury cars, over-the-counter medicines, medical devices, or mobile-phone batteries — become almost totemic reminders of what a lapse in quality can mean. And for manufacturers everywhere, simultaneous increases in supply-chain complexity and media reach mean that the aftershock of a quality lapse is likely to be much larger than in the past. But despite their impact, these events are only part of the story. As important as it is to prevent rare disasters, focusing too closely on them can distort an organization’s understanding of what quality really means.Fundamentally, quality is about meeting or exceeding customer expectations: every day, every…
  Full Story
  
  Recent
  
  Improving Digital Quality in the Pharmaceutical Industry
  
  Reg Vision
  
  Transforming Bioburden Risk with Digital Asset Intelligence
  
  Product Focus: Environmental Controls
- Product/Process |
  Degrees of Digitalization
  
  Armed with the education and motivation, pharma now needs a plan
  
  It’s not too late for the pharmaceutical industry to dodge its reputation for being woefully behind other industries in terms of adopting technology. Pharma, facing somewhat of a “digital crossroads,” is still poised to capitalize on the vast…
  Full Story
  
  Recent
  
  Smarter Access to Analytics for Process Engineers
  
  True Process PLM: The Future of Pharma Manufacturing
  
  PLM for Pharma: Applying an Old Tool in New Ways
  
  Paving the Road for Sustainable Solutions
- ERP
  Achieving Real-Time Results Without Infrastructure Investments
  
  How Pharmavite streamlined operations and boosted capacity from existing assets
  
  California-based nutraceutical company, Pharmavite, is the maker of Nature Made vitamins and supplements — the #1 selling national vitamin and supplement brand in traditional retail outlets, and the #1 pharmacist recommended brand, according to U.S. News & World Report. With over 120 products and rapidly growing customer demand — coupled with complex manufacturing and packaging processes — the management team at Pharmavite realized that they needed to streamline operations and get more capacity from their existing assets. THE CHALLENGEPharmavite was using Microsoft Word and ERP entry forms to track uptime performance, then moved to an Excel-based OEE tracking system. These solutions were neither real-time nor capable of capturing…
  Full Story
  
  Recent
  
  Making the Move
  
  China Drugmaker Drops Paper-Based Documentation
  
  True Process PLM: The Future of Pharma Manufacturing
  
  Save Money, Make Money: IT Integration and Data Exchange
Compliance
- cGMPs|
  FDA looks to shut down unapproved stem cell clinics
  
  The U.S. FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval, citing significant deviations from current good manufacturing practice requirements.
  
  The U.S. FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval, citing significant deviations from current good manufacturing practice requirements. A permanent injunction is being sought against U.S. Stem Cell Clinic in Sunrise, Florida, for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products. Additionally, the FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, and Cell Surgical Network Corporation of Rancho Mirage, California from marketing…
  Full Story
  
  Recent
  
  FDA adds EpiPens to drug shortage list
  
  Atrium Innovations Modernizes Quality Management
  
  Tris Pharma, a Pfizer CMO, warned by FDA
  
  Aurobindo injectables facility hit with 483 due to cleanliness
- Compliance Management |
  Maximum and Minimum Loads in Steam Sterilization
  
  Establishing a cycle development strategy that fulfills regulatory requirements
  
  Steam sterilization is a critical process in the manufacture of many pharmaceutical and medical device products. Because of its importance and wide usage it receives a great deal of attention from both practitioners and regulators. Despite this focus, there are aspects relating to load size that prove troublesome, and can cause difficulty during sterilization cycle development, and validation. Regulators will routinely query users on their means for validation of varying load sizes in both pre-approval and routing inspection. The regulatory expectation is that the user has validated fixed and invariable load patterns, and thus load sizes for all sterilization processes.¹,² This is expected for both parts (porous) and terminal…
  Full Story
  
  Recent
  
  Reg Vision
  
  FDA Implements Rapid REMS
  
  GSK Gains First FDA Approval for Autoimmune Disease Drug
  
  Sanofi-Aventis Wins FDA Approval for Follow-On Diabetes Drug
- Regulatory Guidance|
  FDA pushes social media sites to do more to curb opioid sales
  
  During his speech at the National Rx Drug Abuse and Heroin Summit, FDA Commissioner Scott Gottlieb announced that the agency will be inviting internet company leaders to a summit to discuss potential solutions to the tech industry's role in the U.S. opioid crisis.
  
  During his speech at the National Rx Drug Abuse and Heroin Summit, FDA Commissioner Scott Gottlieb announced that the agency will be inviting internet company leaders to a summit to discuss potential solutions to the tech industry's role in the U.S. opioid crisis. According to Gottlieb, the FDA is concerned about the role social media companies and internet service providers are playing in the online sale of opioids. The agency has found offers to purchase drugs on Twitter, Facebook, Instagram, Reddit, Google, Yahoo and Bing. At the proposed summit, the agency plans to bring together tech executives, academics and advocacy groups in order to facilitate a discussion about current gaps in technology and work to reduce opioid availability…
  Full Story
  
  Recent
  
  EU FMD: The One-Year Countdown
  
  The State of Pharma in Trump’s Union
  
  FDA releases new guidance to speed generic drug review
  
  Reg Vision
- Validation
  EU FMD: The One-Year Countdown
  
  Companies that manufacture, sell or dispense drugs in the European Union have until February 9, 2019 to comply. Where does the industry stand?
  
  The Falsified Medicines Directive (FMD) was enacted by the European Commission in 2011. The directive introduces harmonized European measures to prevent falsified medicines from entering the legal supply chain. Companies that manufacture, sell or dispense medications in the European Union have until February 9, 2019 to comply with the track and trace regulations outlined in the directive. Overall, the FMD covers three regulatory areas: serialization, compliance reporting and verification. The directive requires companies to place “safety features” on the packaging of certain medicinal products for the purposes of identification and authentication. Specifically, according to the directive, safety features include anti-tamper devices…
  Full Story
  
  Recent
  
  Validation & Qualification in Pharma Facilities
  
  Why Are Paper Mountains Still Common in Validation?
  
  BRIEF: How Humidity and Temperature Mapping Differ
  
  Leveraging Third-Party Audits in Pharma/Biotech Industries
Quality & Risk
- Quality & Risk Management|
  India regulators to re-inspect 147 drug plants
  
  A joint team of central and state drug regulators in India will re-inspect 147 drug manufacturing plants that have been under scrutiny over the last two years.
  
  A joint team of central and state drug regulators in India will re-inspect 147 drug manufacturing plants that have been under scrutiny over the last two years, reports the Economic Times. The team will conduct a risk-based inspection exercise to ensure that drug manufacturing plants have taken measures to improve product quality. Companies that were found non-compliant during the first round of inspections — initiated in 2016 — were allowed time to plug deficiencies. The re-inspections are expected to occur in the next three weeks and may involve punitive action against firms not complying with prescribed good manufacturing practices. Read the Economic Times coverage
  Full Story
  
  Recent
  
  FDA accuses manufacturer of ignoring quality control tests
  
  Transforming Bioburden Risk with Digital Asset Intelligence
  
  Toward Zero Defects: Using Analytics to Reshape Quality
  
  Simplifying Flow and Level Instrument Verification
- Quality Management Systems|
  Atrium Innovations Modernizes Quality Management
  
  Atrium improves audits and complaints, change control, and product release processes with immediate access to information and operational visibility
  
  “If you're proactive, you focus on preparing. If you're reactive, you end up focusing on repairing,” wrote John Maxwell, the #1 New York Times bestselling author and leadership coach. Maxwell’s comments are as relevant to a CEO as they are to a quality manager in life sciences — especially when it comes to making technology decisions. Many life sciences organizations use legacy systems or paper-based processes for quality management. Difficult to manage, maintain, and scale, these manual solutions require a lot of overhead and limit visibility. Without the ability to easily share information, teams, sites, and departments across quality often work in siloes. As a result, processes take longer and it is challenging to be proactive…
  Full Story
  
  Recent
  
  Lean Laggards: Exploring the State of Lean in Pharma
  
  Designing the Next Generation of Quality Management Systems
  
  Transforming Bioburden Risk with Digital Asset Intelligence
  
  Toward Zero Defects: Using Analytics to Reshape Quality
- Supply Chain
  Personalization Status: It’s Complicated
  
  In the 10 days following the news about Facebook’s data privacy breach involving political consultancy, Cambridge Analytica, Facebook shares dropped almost 18 percent.This was a prime example of consumers’ love/hate relationship with personalization. On the one hand, we’ve come to expect that marketers know us and what we want. We no longer have the patience to sift through information that isn’t relevant to our interests.In this regard, personalization has made life exponentially more efficient. But reducing the amount of time spent sifting through non-targeted marketing adds an additional layer of complexity further down the chain. When it comes to personalized marketing, this complexity comes in the form of data privacy…
  Full Story
  
  Recent
  
  Digital Transformation Facilitates On-Time Delivery
  
  3 Reasons Why the Pharma Supply Chain is Ripe for Digital Transformation
  
  Biopharma CMO Consolidation: Opportunity or Obstacle?
  
  Novartis operations head resigns, ops division splits
Facilities
- Asset Management|
  OEE Overview
  
  Industry experts weigh in on the application and value of Overall Equipment Effectiveness in pharma
  
  Pharmaceutical manufacturers continually strive to improve the quality of their products along with improving their production operations. Over the years, many manufacturers empowered their workforce to follow the management techniques of Six Sigma — the statistical-based, data-driven method to reduce costs and increase profits, and Kaizen — the gradual and methodical process to boost productivity by improving the work environment. These initiatives can bring improvements to an operation as long as the manufacturer has a structured means of measuring the results by hour, shift, day, week and so on. One such key performance indicator, or KPI, is Overall Equipment Effectiveness (OEE). OEE is a measure of how effectively a manufacturing…
  Full Story
  
  Recent
  
  Lean Laggards: Exploring the State of Lean in Pharma
  
  Transforming Bioburden Risk with Digital Asset Intelligence
  
  Pharma’s Untapped Gold Mine: Logistics Excellence
  
  Establishing a Root Cause Failure Analysis Program at a Pharma Facility
- Containment & Cleanrooms|
  Sizing Up the Benefits of Sterile Drug Manufacturing Techniques
  
  A comparison of several sterile processing techniques, including aseptic isolators, restricted access barrier systems and aseptic Split Butterfly Valve technology
  
  Sterile manufacturing environments are open to many sources of potential contamination if not managed correctly: air filtration systems, materials transfer and, not to mention, operators — a fully gowned operator may create as many as 150,000 particles per minute, many of which are viable and are potential hazards during the manufacture of sterile drugs. The need to ensure the safe and sterile transfer of active pharmaceutical ingredients (APIs) and formulation ingredients during aseptic processing has driven the development of multiple techniques that can be employed in cleanroom environments to minimize the risks from contaminants. APPROACHES TO ASEPTIC MANUFACTURINGBarrier technologies, such as isolators and RABs, are designed to…
  Full Story
  
  Recent
  
  GMP in Cleanroom Maintenance: Myths and Facts
  
  AdvantaPass
  
  VS-050 Six Axis Aseptic Robot
  
  Risky Business: High Potency Products
- Energy Management|
  Benchmarking Biopharma's Carbon Footprint
  
  GSK demonstrates how to achieve sustainability and develops a carbon footprint pathway for the industry.
  
  All across our industry, healthcare organizations are implementing sustainability activities as a positive and visible aspect of their corporate responsibility goals. In the case of GlaxoSmithKline (GSK), the goals are ambitious. GSK envisions a carbon neutral value chain by 2050, aiming for sustainable water use, and waste reduction and recycling. GSK VISIONGSK’s efforts can be an inspiration to other companies looking for a starting point for their own environmental sustainability efforts. While GSK had developed carbon footprint models for small molecule products in other business units, the biopharmaceutical business unit within its R&D organization began a pursuit to understand the environmental impact of monoclonal antibody and…
  Full Story
  
  Recent
  
  Saving Money at the Loading Dock
  
  How to Select the Right Compressed Air System
  
  Delta DSV Steam Trap
  
  Controlling Emissions the BAT Way
- Facilty Design & Management|
  OEE Overview
  
  Industry experts weigh in on the application and value of Overall Equipment Effectiveness in pharma
  
  Pharmaceutical manufacturers continually strive to improve the quality of their products along with improving their production operations. Over the years, many manufacturers empowered their workforce to follow the management techniques of Six Sigma — the statistical-based, data-driven method to reduce costs and increase profits, and Kaizen — the gradual and methodical process to boost productivity by improving the work environment. These initiatives can bring improvements to an operation as long as the manufacturer has a structured means of measuring the results by hour, shift, day, week and so on. One such key performance indicator, or KPI, is Overall Equipment Effectiveness (OEE). OEE is a measure of how effectively a manufacturing…
  Full Story
  
  Recent
  
  Takeda invests in stem cells with new facility, jobs
  
  Cutting-Edge Flexibility
  
  Monitoring Plant Utilities for Operational Excellence
  
  PDA Annual Meeting Recap
- Water/Waste
  Advances in Ultrafiltration Improve Pharma Wastewater Treatment
  
  How a renowned biopharma manufacturer in India employed advanced ultrafiltration membranes to handle challenging industrial effluents
  
  Wastewater treatment is an important part of pharmaceutical manufacturing for several reasons. First, the pharmaceutical industry requires a large volume of water for various processes, and chemicals and other substances used in the manufacturing process often result in copious amounts of wastewater with high levels of contaminants and/or organic content that require specialized treatment (whether for reuse or ultimately, discharge). Second, companies are increasingly integrating recycled water into their industrial processes. This practice can yield significant benefits from an environmental standpoint, through the conservation of raw water resources or by helping to reduce energy consumption. However, wastewater destined for recycling…
  Full Story
  
  Recent
  
  Benchmarking Biopharma's Carbon Footprint
  
  Lobby Group Links Drug-Resistance to Water Near Indian Plants
  
  FDA, CDC Link Outbreak to PharmaTech's Water System
  
  Modular Approach to Water Processing Control & Automation
Sector
- Contract Manufacturing|
  Recipharm to buy Sanofi contract business, plant
  
  Swedish CDMO, Recipharm, has struck a deal with Sanofi to buy the French drugmaker’s contract inhalation drug business and plant in the U.K.
  
  Swedish CDMO, Recipharm, has struck a deal with Sanofi to buy the French drugmaker’s contract inhalation drug business and plant in the U.K.Sanofi's Holmes Chapel manufacturing facility is a leading contract manufacturing site in Europe and is home to a team of more than 450 specialist employees. All employees will automatically transfer to Recipharm.Recipharm will pay about £45 million ($60.2 million) for the 125,000-square meter site near Manchester.Read the press release
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  Recent
  
  Novartis sells injectables plant to Avara
  
  Tris Pharma, a Pfizer CMO, warned by FDA
  
  Many Knives in the Air
  
  Cutting-Edge Flexibility
- Large Molecule|
  Gates Foundation introduces non-profit biotech
  
  The Bill and Melinda Gates Foundation introduced its nonprofit biotech spinoff — the Bill and Melinda Gates Medical Research Institute (MRI) — focusing on diseases that disproportionately affect the poor.
  
  The Bill and Melinda Gates Foundation introduced its nonprofit biotech spinoff — the Bill and Melinda Gates Medical Research Institute (MRI) — focusing on diseases that disproportionately affect the poor, at the 2018 BIO International Convention this week.The MRI aims to develop new medicines and vaccines for malaria, tuberculosis and diarrhea — and hadsfunding of $273 million for its first four years in order to do so.The biotech will be headed up by Dr. Penny Heaton, a vaccine developer recruited from Novartis. The institute opened its doors in January in temporary space in Cambridge, Mass.Without the concern over profit, the drug company can measure success in lives saved, not dollars returned, explained Trevor Mundel, head of…
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  FDA says PBMs are "complacent participants" in biosim delays
  
  AbbVie, Samsung Bioepis make Humira biosim deal
  
  Sun Pharma gets green light for first U.S. biologic
  
  Stem Cell Therapy: Resolving the Mismatch
- Small Molecule|
  Why Cookies Crumble
  
  An understanding of how ingredients affect the entire process helps improve quality
  
  Tablet manufacturing is like baking, explains Mike Tousey, as he demonstrates blend uniformity I've always hated baking. Even when I attempt to carefully follow a recipe, I still end up with sub-standard cookies and a counter full of flour. Furthermore, it never ceases to baffle me that two batches of cookies coming from the same bowl of dough manage to fail in two totally different ways. Oddly enough, my ancestors were actually bakers from the small town of Maikammer, Germany. Niklaus Langhauser received his Meisterbrief certification for baking in 1924, which uniquely distinguished him as a baker possessing advanced, formal training. Historically, however, bakers learned through apprenticeship rather than technical education. Knowledge…
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  A Better Batch
  
  Shire, Rani Therapeutics Partner on Hemophilia A Study
  
  Biogen, Alkermes Partner on Multiple Sclerosis Drug
  
  Automating Excipient Selection
- Generic|
  FDA approves first generic Suboxone
  
  Mylan and Dr. Reddy's Laboratories have both received FDA approval to make the first generic versions of a Suboxone under-the-tongue film for the treatment of opioid addiction.
  
  Mylan and Dr. Reddy's Laboratories have both received FDA approval to make the first generic versions of a Suboxone under-the-tongue film for the treatment of opioid addiction.However, approval does not mean the generic product — a film strip that combines buprenorphine and naloxone — will quickly enter the market. Indivior, the patent-holder, announced that U.S. district court of New Jersey had granted it a restraining order compelling rival drugmaker Dr. Reddy's to temporarily cease activities related to the development and marketing of the drug. Mylan had previously reached a settlement with Indivior, agreeing to delay launching its generic until 2023.The Suboxone brand brought in as much as $2 billion in sales a year for…
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  Recent
  
  FDA rejects Mylan’s generic Advair again
  
  Generic But Mighty
  
  FDA says PBMs are "complacent participants" in biosim delays
  
  ANDA Tips From the FDA
- Over-the-Counter
  Teva, Procter & Gamble end OTC venture
  
  Teva Pharmaceuticals has agreed with Procter & Gamble to terminate the PGT Healthcare partnership that they founded in 2011 to market OTC medicines.
  
  Teva Pharmaceuticals has agreed with Procter & Gamble to terminate the PGT Healthcare partnership that they founded in 2011 to market OTC medicines. PGT Healthcare had grown into a significant presence in over 50 countries, mainly in Europe and Asia, using market-leading brands such as Vick’s and Ratiopharm. But after nearly seven years of working together, the companies concluded that their priorities and strategies were no longer closely aligned. Each company will take back its own brand and product assets to re-establish independent OTC businesses. The separation is planned to take effect July 1, 2018. Read the press release
  Full Story
  
  Recent
  
  GSK pulls bid for Pfizer OTC
  
  Bayer recalls Alka-Seltzer due to packaging issues (again)
  
  Sun Pharma recalls over 17.5K bottles of nasal spray in U.S.
  
  Horizon painkiller price has jumped 2000 percent since 2013

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