New Manufacturing Equipment Targets Increased Tablet Production Efficiencies
Equipment manufacturers are developing production and packaging systems designed specifically to increase productivity while maintaining quality and reducing costs.
Several recent trends in the pharmaceutical industry are converging to squeeze profit margins for drug manufacturers, who are adopting multiple strategies in response. Increasing production efficiency is one key approach, and equipment manufacturers have been responding with the development of production and packaging systems designed specifically to increase productivity while maintaining quality and reducing costs. In biopharmaceutical manufacturing, the adoption of single-use equipment for both upstream and downstream processes at increasingly larger scales and the introduction of equipment designed for integrated continuous manufacturing are two examples.
For small-molecule manufacturing, significant progress has also been made in…
Industry Voice 2015
Pharmaceutical Tools of the Trade
Critical Success Factors in Raw Material Storage & Conveyance
Automating Blood Cell Population Separation
PDA Annual Meeting Makes Magic
Chad Juros inspired the crowd with his story and his magic, but closed his talk by saying, "The true magicians in this world are those who are bringing these miracle treatments and services that saved my life."
The start of the 2015 Annual Meeting was magic…literally. Chad Juros, founder of the Spread the Magic Foundation, a nonprofit corporation that performs magic to raise money for pediatric cancer patients, started the three-day conference with a message of positivity and gratitude. A childhood cancer survivor and medical miracle, Chad’s father taught him magic as a survival tactic, a way of diverting attention from the negative to the positive in his life. But as accomplished as he is, Chad closed his speech by admitting he, in fact, does not know “real” magic. “The true magicians in this world are those who are bringing these miracle treatments and services that saved my life,” Chad said. “I’m living proof that the hard work…
Ascent of the Robots
No Man’s Land
Applying Single-Use Efficiencies to Room-to-Room Fluid Transfer
Aptuit to Divest Two Non-core Sites
Mature Quality Systems: What Pharma Can Learn from Other Industries
Pharma can take inspiration from industries with mature quality systems and advanced quality capabilities
Quality has a special meaning in pharmaceuticals, where production or distribution errors can jeopardize human life. But other industries face similar challenges, and some have developed sophisticated quality systems. As pharmaceutical companies look for ways to improve their quality practices and performance, they can take ideas from these quality leaders and adapt them for pharma.
Quality can be defined in various ways, from “fitness for purpose” to “meeting customer expectations” to predictability in statistical terms. Each industry understands quality differently, and priorities depend on the specifics of products and markets. In the automotive industry, for instance, companies generally define quality as the ability to meet…
Integrated Continuous Manufacturing
Implementing Risk-Based Validation Team-by-Team
ISPE Names Pfizer as Facility of the Year Winner
Energy Efficiency Makeover Yields Utility Incentive Rewards
How to Integrate Multigenerational Automation Systems
Improving legacy automation systems can present a variety of challenges
Process manufacturing plants are famous, some would say notorious, for their tendency to keep automation systems and associated networks up and running for decades. Some estimates suggest that easily half of the automation systems controlling North American plants have parts that are at least 20 years old — and 30-year-old systems aren't rare either.
Those systems don't look like they did when they were initially installed. Hard disk drives, monitors and keyboards that receive constant use simply don't survive over decades, and such old equipment isn't available anymore.
If you ask your local computer store for an IBM XT motherboard and 20MB hard drive, you'll get some puzzled looks. So unless your automation systems are brand-new, they…
Prepare Now for DSCSA Serialization
More than putting numbers on a bottle, looming regulations will have a profound impact on enterprise IT architecture, operational processes supply chain readiness
Serialization and related track and trace regulations are now a strategic requirement. For pharmaceutical companies, the supply partners they work with to produce life-saving medicines, and the distribution trade partners that ensure these medicines get to the patients who need them worldwide, track and trace requirements are rapidly becoming a daily part of normal operations in the pharmaceutical supply chain. Propelled by a growing counterfeit drug threat that kills more than 100,000 people annually, regulations for drug serialization, supply chain traceability, and government reporting will affect almost 80 percent of the world’s drug supply by the end of 2018. From the United States and the European Union to China, Brazil, and more,…
West to Break Ground at Waterford, Ireland, Manufacturing Plant
Efficient Development of Generic Metered Dose Inhalers
GSK Australia Gets $1M Grant for BFS Project in Boronia
VS-050 Six Axis Aseptic Robot
Exploring the Benefits of Real-time Particle Sizing
The optimization and scale-up of wet granulation processes is often an essential step in the commercialization of oral solid dosage (OSD) products. Granulation enables the preparation of an optimized blend for tableting in which small quantities of highly potent active ingredients (APIs) are stably and homogeneously distributed. Furthermore, granule properties can be manipulated to control, for example, the flowability of the blend and its compressibility. In these ways granulation underpins the manufacture of high-quality tablets with consistent dose uniformity.Wet granulation, and in particular high shear wet granulation, is the technology of choice for many OSD production processes. Compared with alternative methods, high shear…
Solid Dose Realities: Reaching for More
PAT & Quality by Design Conference
Analysis of a Batch Fermentation Process Using Raman Analyzers
Design Weighing Processes with Quality in Mind
Pharma Equipment Sourcing Strategies
2015 Nice Insight Pharmaceutical Equipment report reveals trends in purchasing
Dramatic changes in the pharmaceutical and biopharmaceutical landscape over the past decade have reshaped manufacturers' equipment and technology needs and purchasing patterns. The leading trends driving the transformation include the changing pharmaceutical pipeline, the shift to overseas manufacturing sites, new regulatory guidelines calling for use of the latest technologies to improve quality and efficiency, and a significant increase in outsourcing. Compounding these changes are continuous pressures to cut costs, improve efficiency, elevate quality and boost productivity. Together, these trends have had a significant impact on equipment and technology acquisition strategies.
What are purchasing and operations managers seeking today…
Pall Life Sciences Wins Interphex Best-in-Show Distinction
Trends Impacting Pharma Equipment
Management’s Role in Sustaining Continued Process Verification
Where Is Biopharma in the PAT Picture?
The quest for “knowing exactly what’s in the soup”
The first thing to remember is that Analytical Chemists (ACs) and Biochemists (BCs) see the world differently. Analytical types have always worked with inferential tests: color changes, odors, precipitates (for classes of elements) and felt comfortable using “clues” to deduce the answer. Biochemists, especially in the drug industry, are always attempting to be specific. If a reaction is proceeding, what is being used and produced; if it has ended, what is left in the reactor and what was produced.
They want to know the exact composition of the “soup.” So when PAT was broached to the ACs, for example, blend uniformity testing, we felt fine just seeing that the spectra stopped changing, implying that the mixing was complete. BCs tend…
Taking a Closer Look at ICH Q2 (R1)
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…
Process Cooling as Part of a Sustainable Strategy
Study Says Published Papers Fail to Report Clinical Trial Violations
When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.
A new New York University analysis found that when the FDA's finds serious problems with how medical researchers collect their data, the peer-reviewed literature often doesn't mention it.Using documents and data from 1998 to 2013, researchers identified 57 clinical trials that received an “official action indicated” violation for reasons including inadequate or inaccurate recordkeeping, false information and poor patient safety.
And yet, among the 78 published analyses of data from those sanctioned trials, only three noted violations.
One example was found where the entire clinical trial was deemed unreliable by the FDA, and the published paper failed to make mention of this. In another example, the published paper claimed all…
Management Holds the Key to Continued Process Verification
Rapid Micro Biosystems Announces Availability of Bi-Directional LIMS Integration
Four Pivotal Steps in Early Stage MDI Formulation
Advanced Analytics Improve Biopharma Operations
ACEA Biosciences Introduces "Fail it Fast" Assay Technology
New xCELLigence RTCA CardioECR is the first platform for simultaneous measurement of Cardiomyocyte Contractility and Electrophysiology
Responding to the need for more predictive preclinical assays for cardiac liability, ACEA Biosciences introduced a “ground-breaking” device the company describes as “next generation.” Designated the xCELLigence RTCA CardioECR System, it is…
Archived Webinar: QbD Development of a Purity Method Using UPLC and Mass Detection
Biopharmaceutical Process Control: Part Two: Process Modeling
Photonics for Improved Pharma Process
From tablet marking to quality assurance, lasers and machine vision are boosting functionality and efficiency
In the multidisciplinary pharmaceutical industry, photonics plays an increasingly crucial role in the manufacturing process. From quality assurance to marking, the scope of photonics is wide-reaching. Specifically, the use of lasers and machine vision in oral solid dose (OSD) manufacturing is revolutionizing functionality, security and speed while reducing costs and boosting efficiency.
In certain regions of the world, a growing problem concerns medication quality, stemming from poor manufacturing processes. For example, drugs manufactured with a lower dosage of active ingredients than approved by regulators is a dangerous situation that can lead to patients not receiving a medication's full benefit. Worst-case black market scenarios…
Focusing Its Customer’s Customer Focus
Heard it on DCAT Street
How to Justify Innovation and QbD in Manufacturing
CMOs: Pharma's Heavy Lifters
When it comes to drug development and commercialization, Contract Pharma is bringing the brains and the brawn to do Pharma’s heavy lifting
It’s always exciting to see how a given industry responds to the market’s dynamics, and for pharmaceutical contract services companies these are exciting times indeed. For the longest time, this segment served Big Pharma from behind the scenes. Like Cinderellas, contract manufacturing, development and research companies (CMOs, CDMOs and CROs in the industry’s lexicon) were relegated to the back of the house, engaged at the servant’s entrance to serve in mundane and discrete roles, delivering API and excipients, clinical trial supply, or for some, extra commercial capacity to speed to market and meet the demand for a successful new therapy. For the most part, contract services companies became the towel boys and water carriers to…
PerkinElmer Equips J&J Innovation JLABS’ Incubator
Can Current Investment in New Drugs Be Sustained?
Popular Charity, Public and Private Sector Collaborate to Fight Genetic Disorders
Managing Regulated Content Enterprise-Wide
Kythera content management platform shaves TMF reconciliation time by 40 percent
Kythera is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. The company’s objective is to develop prescription products using an approach that relies on the scientific rigor of biotechnology to address unmet needs in a rapidly growing market. Kythera’s initial focus is on facial aesthetics — the market’s largest segment. The company’s drug for the reduction of submental fat is currently in late-stage clinical development.
SYSTEM TO IMPROVEKythera sought a system to improve clinical document management and facilitate business processes for the development of its newest product candidate. The company had 26…
Proper Process Prevents Poor Lab Performance
Johnson & Johnson Updates Belgium Site’s MES
Veeva Systems Named a CRM Leader by Nucleus Research for the Second Consecutive Year
NIH Puts Big Bucks in Big Data
Glassholes in the Workplace
Pharma's Need to Know
Get Ready to Leverage Mobile Device Control Strategies
Smart glasses may not have won over the hearts of consumers, but they may have promise in pharma manufacturing
When Google unveiled Google Glass to the world in 2012, selling prototypes to qualified candidates the following year, and finally to the general public in May 2014, they probably aspired to achieve a lot of things, but I'm guessing coining the term "glassholes" was not on their list.
As the potential intrusion of privacy overshadowed the allure of new technology, people — and legislators — started hating on Google Glass, banning the "surveillance devices" from restaurants, theaters, casinos and behind the wheel. As purveyors of privacy clashed with technophiles, the term glassholes was born.But smart glasses may have found a home in manufacturing, and new technology is promising to bring augmented reality into the biopharma plant…
FDA, EPA to Share Data on Pesticides, Toxic Substances
Building Drug Better Submissions
Don’t Slow Your EQMS Adoption Roll
QA/QC Labs and Smart Infrastructure Equal End-to-End Quality by Design
Wall Street-Savvy Cybercriminals Target Pharma: Have You Been Hacked?
A new report from FireEye says that a cybercriminal group has been stealing data from more than 100 organizations, mainly targeting publicly traded health care, pharmaceutical and biotechnology companies, to gain insider knowledge to manipulate the stock market.
A new report from U.S. security firm FireEye says that a cybercriminal group known as FIN4 has been stealing data from more than 100 organizations, mainly targeting publicly traded healthcare, pharmaceutical and biotechnology companies, to gain insider knowledge to manipulate the stock market.
FireEye reports that the cybercriminals have targeted the email accounts of individuals privy to the most confidential information of more than 100 companies. According to the report, "FIN4 appears to have a deep familiarity with business deals and corporate communications, and their effects on financial markets. Operating since at least mid-2013, FIN4 distinctly focuses on compromising the accounts of individuals who possess non-public…
Genentech's DAWN Patrols Critical Assets Across Campus
BioSolve Process 5
Multivariate Data Analysis for Biotechnology, Bio-processing
Linking Labs to ERP Lifts Enterprise-level Productivity
Laboratory informatics software, enterprise systems and document management tools provide Janssen-Cilag a fully integrated pharmaceutical manufacturing environment
Specializing in pain management and fungal disease, Janssen-Cilag Farmacêutica Ltda., is a research-based pharmaceutical company located in São Paulo, Brazil. Janssen-Cilag is a member of the Johnson & Johnson family of companies — the world’s largest personal care and health products manufacturer with worldwide annual sales totaling $63.7 billion. In an effort to streamline business processes, Janssen-Cilag’s Global Pharmaceutical Supply Group (GPSG) Brazil recently adopted a comprehensive enterprise integration solution. As part of its quest for a state-of-the-art IT implementation, GPSG Brazil took advantage of the latest technological advancements from Thermo Scientific in its São José dos Campos laboratory complex in…
QMS vs. ERP: Use The Overlap to Your Advantage
Survey of India Pharma Attributes Compliance Woes to Shortage of Skilled Manpower
A recent Deloitte India survey of risk and compliance professionals at India-based pharmaceutical companies found that a shortage of skilled manpower is cited as the leading reason that India drug companies are unable to keep pace with rapidly changing regulatory environments.
A recent Deloitte India survey of risk and compliance professionals at India-based pharmaceutical companies found that a shortage of skilled manpower is cited as the leading reason that India drug companies are unable to keep pace with rapidly changing regulatory environments.
According to the survey results, 64 percent of survey respondents attribute non-compliance to shortage of skilled staff (on their risk and compliance teams), followed by challenges in implementing cGXP guidelines (52 percent), complying with professional association guidelines (42 percent), and poor fraud risk management systems (36 percent).
Additionally, close to 50 percent of survey respondents indicated that data management systems and pharma quality systems were…
API Maker VUAB Pharma Receives FDA Warning Letter
CSM to Build Second cGMP Facility in Malvern, PA
Pfizer's Newly-Acquired Hospira Warned by FDA
India's Kemwell Biopharma Announces Successful FDA Inspection
DOJ Seeks $3.35B from Novartis for Kickback Schemes
Feds say Novartis used rebates and other plans to entice pharmacies to boost prescriptions
According to a Wall Street Journal article, the U.S. Department of Justice is asking Novartis to pay up to $3.35 billion in damages and civil fines for using kickbacks to boost sales of two drugs that caused federal health care programs to overpay for medicines.
The article says Novartis violated the False Claims Act by using rebates and other plans to induce specialty pharmacies to boost prescriptions for two drugs: the Myfortic treatment for kidney transplants and Exjade, a medicine used for reducing excess iron in patients who undergo blood transfusions.
Read the Wall Street Journal story
FDA Approves Hospira's India Plant for Limited Production
New Antiplatelet Drug Approved for Heart Surgery
The People Factor – Where 80% of the Solutions to Quality Issues Reside
Controlling Emissions the BAT Way
The release of volatile organic compounds into the atmosphere is coming under intense scrutiny
With an ever-increasing number of processing plants coming on stream worldwide to keep up with the rapidly expanding pharmaceutical and biotechnology industries, the focus on the release of volatile organic compounds (VOCs) into the atmosphere is coming under intense scrutiny by environmental authorities.VOC is the common descriptor for a wide variety of hydrocarbon-containing chemicals. They are numerous, varied and ubiquitous, and the risks associated with them are aggravated by the fact that hazardous concentrations are usually very low and the health issues they can cause can be accumulative and slow to develop. The release of VOCs from industrial processes not only poses a direct potential hazard to human health, but their release…
How Humidity and Temperature Mapping Differ
Leveraging Third-Party Audits in Pharma/Biotech Industries
FDA's New Diabetes Drug Warning Includes Meds from J&J, AstraZeneca, Lilly
Alarming Amount of FDCs Sold in India Without Central Regulatory Approval
BRIEF: How Humidity and Temperature Mapping Differ
There are a few special considerations for mapping humidity: calibration and sensor density/placement.
It has become more common to validate humidity as well as temperature in controlled environments in order to meet GxP requirements. Typically we use the same methods for humidity mapping as for temperature, however, there are a few special considerations for mapping humidity.
1) CalibrationVerify that calibration certificates are available for the humidity sensors, and that each sensor was within its calibration interval at the time of use.
2) Sensor Density & PlacementThe simplest practice is to use the same number of humidity and temperature sensors. If fewer humidity sensors must be used, it is important to understand humidity measurement well enough to explain to an auditor what the expected humidity values would be (based on…
How to Select the Right Compressed Air System
BRIEF: Prepare Now for DSCSA Serialization
Perrigo Purchases Patheon's Mexican Operations
Belle of the Contract Manufacturing Ball
Correct design basis requires deep understanding of raw material characteristics and facility conditions
A well-designed, reliable raw material storage and conveyance environment can make or break a pharmaceutical manufacturing environment. Raw material storage and conveyance is fundamental to quality assurance and profitability. Increasingly, this environment also has become integral to the rigorous regulatory requirements for tracking and tracing products throughout the supply chain. To meet quality and standardization objectives, a design solution must be based on an overview of the entire process from delivery of raw materials to the manufacturing site to delivery of product ingredients to the manufacturing line. The correct design basis is predicated, particularly, on an understanding of raw material characteristics and facility…
Natoli Offers Tablet Manufacturing and Troubleshooting Training Course
Digitally Spoiled But Not Rotten
How to Find Your Next Pharma Exec
Full Name: AdvantaPass
Team: AdvantaPure, NewAge IndustriesStatus: Patented, ready to bring enhanced single-use efficiencies to fluid transfer
Field Position: Critical fluid transfer points between controlled environments
Skill Set: AdvantaPass combines single-use tubing, connectors and seals with permanent, wall-mounted stainless steel components to eliminate cleaning validations associated with clean room protocols.
Performance Stats:• Cost savings over other pass-through methods that involve multiple moving parts and frequent maintenance• Customizable to accommodate multiple tubing ports, environmental purge ports, and clean room wall thicknesses including floor-to-ceiling conveyance• A choice of…
Risky Business: High Potency Products
Sterilization Methods' Impact on Packaging Component Machinability
“Pharmonics” and the Operator Interface
Each application requires a different level of air quality and a different combination of air treatment to meet the needed specs
In the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing air for pneumatically controlled valves and cylinders, as well as breathing air systems.
Each of these applications requires a different level of air quality and a different combination of air treatment to meet the needed quality. Because the uses of compressed air within the industry vary so greatly, there is no set standard in place that every process must adhere to.
While the FDA may not have issued a directive for compressed air quality in the pharmaceutical industry, there is still a resource available to help select appropriate air treatment…
Delta DSV Steam Trap
SGS Life Science Services Opens Paris Lab
The 2,100-square-meter facility has been designed and built for the needs of the pharmaceutical industry
SGS Life Science Services announced the opening of its new bio/pharmaceutical quality control laboratory at Villeneuve La Garenne, a Paris suburb, replacing an existing facility in Clichy.Opening June 29, 2015, the state-of-the-art laboratory will incorporate best-in-class infrastructure and equipment to meet the current and future demands of its bio/pharmaceutical clients. This multi-million Euro investment will serve the French market, support biologics development, and will operate under Good Manufacturing Practice.The 2,100-square-meter facility has been designed and built for the needs of the pharmaceutical industry, targeting the reduction of sample processing times through increased operational efficiency. All services currently…
Pfizer's Continuous Manufacturing Pod Comes in for a Landing
Closed-loop systems help pharmaceutical manufacturers save water and energy
While the pharmaceutical industry continues on its road to recovery, sustainability will remain a priority for pharmaceutical manufacturers as they strive for profitable growth. One way many can make significant headway toward true sustainability — and improve the bottom line — is through the use of advanced, closed-loop process cooling technology specifically designed to lower water consumption and save energy.
Process cooling efficiency should be on the front burner rather than the afterthought it often is. Doing so is particularly important today given increasing concern over water use by pharmaceutical manufacturers and other companies that use water-intensive processes to make and deliver products. Following are some…
Meeting Global Pharmacopeia Requirements for Water Compliance
Ozone: A New Water Management Paradigm
Investment Partners Buy Controlling Stake in Alvogen
Alvogen has expanded from its original base in North America to commercial operations in 35 countries
CVC Capital Partners, Temasek and Vatera Healthcare Partners have acquired a controlling stake in Alvogen from Pamplona Capital Management. Aztiq Pharma, led by Alvogen CEO Robert Wessman, will remain with a significant stake, as well as Pamplona with a small stake.
Alvogen's lines of business include: product development, contract manufacturing and research (CMO), and sales of generic medicines (Gx and Hx), biosimilars and OTCs. Its product portfolio consists of a broad range of leading molecules for the treatment of conditions in the areas of oncology, cardiology, respiratory, neurology and gastroenterology in addition to a fast growing portfolio of biosimilars and OTC products.
Alvogen says it has delivered six consecutive years of…
Teva Acquires Auspex Pharmaceuticals; Updates Mylan Proposal
Cultivating Better Contract Services
Celgene, Juno Make 10-Year, $1B Immunotherapies Deal
The two companies will leverage T cell therapeutic strategies to develop treatments
Celgene Corp. and Juno Therapeutics announced a collaboration for the development and commercialization of immunotherapies. The two companies will leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases with an initial focus on Chimeric Antigen Receptor Technology (CAR-T) and T Cell Receptor (TCR) technologies, according to a press release.
"This transaction strengthens Celgene's position in the emerging and transformative area of immuno-oncology," said Bob Hugin, Chairman and CEO of Celgene. "Juno has assembled world-class experts and built impressive capabilities and technologies in the areas of T cell biology and cellular therapy; we believe this long-term collaboration enhances the…
Novartis Acquires Spinifex Pharmaceuticals Inc.
Alexion Pharma Purchases Synageva Biopharma
Pfizer to Acquire Nimenrix, Mencevax from GSK
Abbott Backs Mylan's Perrigo Purchase, Helps Fend Off Teva
Congressional Setback for Trans-Pacific Partnership is a Win for Generic Drug Makers
Mylan Launches First Bioequivalent Alternative to GSK's Inhaler
Data Study Finds Link Between Acid Reflux Meds and Heart Attack Risk
Perrigo to Buy GSK/Novartis OTC Brands
Endo Expands Generics Biz, Pays $5B for Par Pharma