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
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Full Name: Piezo Gripper
Team: ParkerStatus: Ready to fill demanding light-touch gripping roles
Debut: January 2015
Field Position: Robotic applications manipulating delicate discrete items safely
Skill Set: Gentle handling of small-scale discrete and fragile items
Performance Stats:• Piezo technology is rugged, offering a lifespan of up to 500,000,000 cycles, compared to others rated at 5,000,000 cycles• Maximum gripping force is 1.235 Newtons, and because the power source is electromechanical rather than pneumatic, the added expense of compressed air is avoided• Device is particularly suitable for processes that are neither nano nor macro, but somewhere in between
Regulatory Profile: Appropriate for cGMP…
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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…
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Optimizing Global Engineering Efficiency
Across major geographies, under-budget projects are the exception rather than the rule
Globalization and disruptive technological advancements, such as virtualization, cloud and big data, are continually altering the industrial landscape. To succeed, innovative companies must re-envision where and how they do business so the right resources are applied regardless of their location. In the past decade, concepts like virtual teaming and multi-office execution began to play major roles in the operating strategies of engineering, procurement and construction (EPC) and global engineering firms. Offshoring is no longer isolated to manufacturing, data processing and call-center positions, as a growing number of firms move engineering, design and development work overseas as well.
IN PURSUIT OF COSTS TO CUTCost reduction is a…
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FDA Strengthens NSAIDs Heart Attack, Stroke Warning
Based on the FDA's comprehensive review of new safety information, the agency is strengthening an existing label warning that NSAIDs increase the chance of a heart attack or stroke.
Based on the FDA's comprehensive review of new safety information, the agency is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. FDA is requiring updates to the drug labels of all prescription NSAIDs.
Per the FDA, prescription NSAID labels will be revised to reflect the following information:
• The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.• The risk appears greater at higher doses.• It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is…
Prepare Now for DSCSA Serialization
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
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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…
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Advances in Process Analytical Technologies
Instrument and PAT vendors are continually innovating, and 2015 is no different
Process Analytical Technology (PAT) and instrument vendors are continually advancing the usability, reliability, accuracy and efficacy of their technologies, and the first half of 2015 is no different. Companies in this sector introduced technological advancements and other innovations to better support lab and QA/QC operations.
When it comes to demonstrating new analytical equipment to the industry, PittCon has traditionally been a primary launching point for introducing PAT systems and innovations to the industry. Several vendors brought out new systems or introduced significant new features at the conference.
SPECTROSCOPYIn the world of PAT/QbD, spectroscopy occupies a leading role. One instrument that should interest physical chemistry…
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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
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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…
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Heard it on DCAT Street
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…
How to Justify Innovation and QbD in Manufacturing
Automated Feeding Enhances Biologics Production
On-demand nutrient addition provides improved cell health, higher product titers and consistent quality
The biopharmaceutical industry long has recognized that nutrient feed control is crucial to process development lead-times and to manufacturing quality, yield and cost. Real-time measurement of physical parameters such as pH and dissolved oxygen is insufficient to achieve dynamic feed control. Instead, companies still depend upon predetermined nutrient regimes or periodic extractive sampling and offline analysis, resulting in suboptimal conditions for cell culture, process delays and risk of infection.
The majority of biopharmaceutical processes use a fed-batch nutrient-feeding regime to maintain cell culture activity. Current fed-batch processes rely on predetermined feeding protocols based on nutrient requirement estimates or infrequent…
CMOs: Pharma's Heavy Lifters
PerkinElmer Equips J&J Innovation JLABS’ Incubator
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Popular Charity, Public and Private Sector Collaborate to Fight Genetic Disorders
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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
PC-based control platform reduces cost by $4,500 per system; smaller machine footprint effectively doubles system throughput
Consumers have grown quite accustomed to having the ability to customize the products they buy, from clothing to cell phone cases, to interior lighting and more. This made-to-order trend is not limited to the consumer space, however. Even biotech research organizations are utilizing highly custom synthetic genetic material to advance discovery. This type of research represents the upper echelons of scientific progress in the pharmaceutical, agricultural, academic, and other life science markets. Genetic study analyzes the basic elements of life, allowing scientists to understand biological processes and make discoveries that protect our world.
Genetic research requires synthetic nucleic acids, DNA and RNA, unique to each application.
Glassholes in the Workplace
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PLM Formulations for Chemicals
The roots of product lifecycle management and how PLM can help chemical companies today
Product Lifecycle Management (PLM) originated in the automotive industry, and as a breed of IT application it is still mainly associated with discrete manufacturing. Having started with the scope of product data management for the development phase of a product lifecycle, the reach of the technology has evolved to cover the full product lifecycle — and close the loop by supporting the exploitation of field experience to drive front end innovation (for example, Oracle seeks to reinforce this by referring to ‘Product Value Chain Management’).The PLM technologies designed for discrete manufacturing industries deliver enormous benefit in product development scenarios involving high numbers of parts with their relationships defined by a…
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Mobius 2000 Liter Single-Use Bioreactor
Full Name: Mobius® 2000 Liter Single-Use Bioreactor
Team: EMD MilliporeStatus: Highly developed, ready for commercial-scale bioprocessing
Debut: June, 2015
Field Position: Leads biopharmaceutical process team
Skill Set: Ease of use, flexible configuration
Performance Stats:• Industry’s first bottom-loading drawer enables easiest Flexware assembly installation on the market• 5:1 turndown ratio provides the most flexible seeding and growth strategy• Patent-pending baffle design gives the mixing performance of a stainless steel bioreactor with no cleaning required
Regulatory Profile: Meets or exceeds cGMP compliance expectations
Coach’s Notes: “Successful development of upstream processes demands…
J&J Awaits Final Clearance to Re-Open Suspended Tylenol Plant, $100M and Five Years Later
FDA Bans Imports from India's Emcure
Fresenius Kabi Fined for Fatal Insulin Manufacturing Deficiency
Brazil Bans Import of Lupin APIs
BMS Gets FDA Breakthrough Designation for HIV Drug
BMS-663068 is the first investigational antiretroviral designed to prevent HIV attachment to and entry into CD4+ T cells
Bristol-Myers Squibb announced the FDA has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients.
The designation is based on data from the Phase IIb clinical study comparing BMS-663068 to a boosted protease inhibitor (Reyataz (atazanavir sulfate) and ritonavir) in treatment-experienced patients, with a treatment backbone across all arms of raltegravir, in addition to tenofovir disoproxil fumarate, BMS says. A Phase III trial in heavily treatment-experienced patients began in February 2015 and is ongoing.
“We are now 30-plus years into the AIDS epidemic, and…
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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
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BRIEF: How Humidity and Temperature Mapping Differ
There are a few special considerations for mapping humidity: calibration and sensor density/placement.
Editor's note: this is a 60-second version of the original article. To read the full length feature, click the link at the end of the brief.
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…
The People Factor – Where 80% of the Solutions to Quality Issues Reside
How to Select the Right Compressed Air System
QA/QC Labs and Smart Infrastructure Equal End-to-End Quality by Design
From tablet marking to quality assurance, lasers and machine vision are boosting functionality and efficiency.
Editor's note: this is a 60-second version of the original article. To read the full length feature, click the link at the end of the brief.
In the multidisciplinary pharma 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. When medicine is inexpensive in less-developed countries but moves through the gray market to be…
BRIEF: Prepare Now for DSCSA Serialization
Perrigo Purchases Patheon's Mexican Operations
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
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Get Ready to Leverage Mobile Device Control Strategies
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…
VS-050 Six Axis Aseptic Robot
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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
West Expands Arizona Manufacturing Capacity
SGS Life Science Services Opens Paris Lab
"Lego" inspired control concept from Festo creates a better fitting, economical method to automate this critical utility
Almost anyone can recognize the practicality associated with the concept of modularity. To the many engineers who busy themselves designing, engineering and constructing complex pharma processing systems, the idea of managing such complexity by breaking it down into standardized subsystems and components is a well understood and pragmatic approach to system design. According to Festo, such is the case with automation and control. Modular systems, say Festo, speed up the design and configuration of automated processes, lower overall costs, and make a process like water filtration more flexible and therefore better at adapting to new operational requirements and responsive to market demands.
"This approach represents a fundamental shift in…
Meeting Global Pharmacopeia Requirements for Water Compliance
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ANI Pharma Buys 22 Generic Drugs from Teva
The acquisition includes 19 solid-oral dosage products and three oral suspension products
ANI Pharmaceuticals Inc. has acquired 22 previously marketed generic drug products from Teva Pharmaceuticals for $25 million in cash and a percentage of future gross profits from product sales. The acquisition includes 19 solid-oral dosage products and three oral suspension products.
ANI will initially focus to tech transfer four products that qualify as CBE30 filings into ANI’s two manufacturing facilities; these four products have a combined trailing 12-month market value of $210 million, according to IMS Health. The total market value for the 22 products is $650 million on a trailing twelve month basis, per IMS Health. The acquisition is being funded through cash on hand.
Arthur S. Przybyl, President and CEO of ANI Pharmaceuticals,…
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Allergan Buys Rights to Merck CGRP Migraine Program
DOJ Seeks $3.35B from Novartis for Kickback Schemes
Abbott Backs Mylan's Perrigo Purchase, Helps Fend Off Teva
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Perrigo to Buy German Naturwohl Pharma
Mylan's current acquisition target Perrigo announced it is buying German pharmacy company, Naturwohl Pharma.
Mylan's current acquisition target Perrigo announced it is buying German pharmacy company, Naturwohl Pharma.
Perrigo did not disclose terms of the deal for Naturwohl and its leading German dietary supplement brand, Yokebe. The transaction has been approved by the boards of both companies.
Perrigo CEO Joseph Papa anticipates the deal will help Perrigo capture a greater share of the $30 billion European over-the-counter market.
Caught in a takeover triangle, Perrigo rejected an unsolicited takeover bid from Mylan in late April, about the same time Mylan rejected an offer of $40 billion from Teva.
Read the USA Today article
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