Manufacturing

Preclinical Immunogenicity Assessment

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Protein therapeutics can potentially elicit immune responses when administered in humans. These antidrug antibodies could result in partial or complete loss of drug efficacy and other complications that have the potential to cause severe adverse effects in the patient. In this webcast, Philippe Stas, Head of Applied Protein Services at Lonza, discusses the benefits of preclinical immunogenicity assessment, including:

• Early-stage Risk Assessment
• Improved Quality and Safety of Drugs
• Reduced Attrition Rate in Drug Development Programs

View this webcast to learn more about managing drug-induced immune responses at the earliest possible stage to produce safer and more cost-effective protein therapeutics.

October 1, 2010

Building Regulatory Compliance for Personalized Medicine

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    Regulatory compliance is the means by which biopharmaceutical companies bring new medicines to market. But as we embark on developing and bringing to market more complex, more personalized medicines in the 21st century, we are about to find that our most experienced sources of compliance know-how and intelligence are getting ready to leave for the comforts of retirement. Demographics are working against the biopharmaceutical industry.   Survey Results   A 2006–2007 survey by the University of Southern California…

September 1, 2010

Containment of High-Potency Products in a GMP Environment

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Many modern medicines are highly potent, with only tiny doses required to achieve a therapeutic effect. But a nanomolar medicine poses extra hazards during manufacturing, whether the product is a biologic or a small molecule. These issues have to be evaluated and addressed in the design of a manufacturing facility for such products. Not only is it vital that the product not become contaminated, but employees and the general public must be protected from the product. Exposure to just a…

September 1, 2010

10 Steps for Choosing a Contract Manufacturer

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    For many young companies, choosing a contract manufacturing organization (CMO) for their lead pharmaceutical candidate is critical. Choose the wrong contractor, and you could be faced with delays and cost overruns — and little sympathy from investors or patients. With so much on the line, how should you make this important decision? It doesn’t need to be based on instinct alone or on overanalysis. With the right set of tools, selecting a CMO doesn’t require endless investigation, and…

September 1, 2010

Sequence Variant Analysis Using Peptide Mapping By LC–MS/MS

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    Monoclonal antibodies are usually expressed in mammalian cell lines and are produced in several variants known as isoforms (1,–2). Microheterogeneity can result from posttranslational and enzymatic modifications as well as those caused by processing, alteration, storage, and incorrect translation of the target protein (1,3). Common sources of heterogeneity include Fc glycosylation, partial carboxypeptidase processing of heavy-chain (HC) C-terminal lysine residues (4), deamidation or isomerization (5), Fc methionine oxidation, hinge-region fragmentation (6), aggregation, and sequence variants. Sequence variants are…

September 1, 2010

Minimizing the Environmental Footprint of Bioprocesses

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    Biomanufacturers must take active measures to minimize their environmental footprints and promote environmental sustainability. The collateral benefit of reducing environmental footprint often is viewed as only a secondary consideration after cost of goods and product quality. Biopharmaceutical processes are 80% defined by the time of proof-of-concept studies (clinical trial stage 2b). This milestone is before the official technical transfer to commercialization or manufacturing organizations and almost always before the environmental evaluation of a production process. This step is…

September 1, 2010

Manufacturing Convergence Technologies

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    Many regenerative medicine products represent a convergence of pharmaceutical, biologic, and medical device technologies. Although such products could have a great impact on medicine, they often pose significant challenges for their developers, requiring companies to incorporate competencies from several technology sectors. By addressing commercial regulatory and manufacturing challenges at an early stage in product development, these companies are more likely to succeed in reaching their commercial goals. Exact regulations governing the manufacture of a convergent technology — or…

September 1, 2010

Quality, Speed and Flexibility by Design

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Accelerating the path to new biomanufacturing capacity typically corresponds with increased costs and the risk of lower quality. Overcoming these compromises requires a holistic QbD-based rethinking of how biomanufacturing is approached. By rethinking biomanufacturing equipment, facility design and services, Xcellerex has achieved dramatic improvements in deployment time, while also reducing capital investment, operating costs, and improving overall quality and compliance. This webcast discusses the advantages of the FlexFactory® Biomanufacturing Platform, such as:

• Multi-product, simultaneous manufacturing
• Open platform for any bioprocessing technology/process control
• 70% reduction on time to build/validate to GMP ready (9mo.)
• And more.

Join Parrish Galliher, Founder and Chief Technology Officer at Xcellerex, as he provides an in-depth look at the technology behind Xcellerex’s FlexFactory Biomanufacturing Platform.

August 1, 2010

Industrial Purification with Convective Interaction Mediaâ„¢ Monoliths

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Monoliths offer a unique set of characteristics that, when properly applied, can significantly improve the overall productivity of the manufacturing processes. In this educational webcast, Tony Brazzale of BIA Separations explores the technology behind the CIMâ„¢ Monolithic Columns and its many benefits, including:

• Increased facility capacity
• Accelerated ROI
• Improved productivity
• Reduced cost of labor and overall COGS

View this educational webcast to learn more about how CIM Monolithic Columns can improve your manufacturing process.

August 1, 2010

A Novel Filtration System Used to Intensify Upstream and Downstream Operations

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Want to improve your bioprocess? The ATFâ„¢ System from Refine Technology was designed to do just that. Used in various bioprocessing applications, this system provides a more reliable and efficient process of cell separation with the inherent ability to support cell growth to extreme concentrations. This educational webcast discusses the Alternating Tangential Flow technology of the ATF System and its many benefits, including:

• Near-linear scale-up
• A filtered product stream ready for purification
• Faster, simpler virus production with a reduced cost of goods
• And more

Join John Bonham-Carter, VP of Sales and Business Development at Refine Technology, as he provides a detailed look at the ATF System, its applications and its benefits.

August 1, 2010