Biologics Production – BioProcessing Journal

Beyond the Stainless Steel — The Real Capacity Crunch…

How do we ensure that the next generation of biotech medicines can be brought to market in a timely way, that they continue to be safe and effective and — of growing importance — are affordable by healthcare funding agencies, and profitable to the companies developing them?…

Biologics Production

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Viral and Prion Clearance Studies

A major concern for medicinal products of biological origin is the potential risk of contamination with known or unknown viruses. Manufacturers of biopharmaceutical products (such as recombinant proteins and monoclonal antibodies, or products derived from blood, tissue, or urine) are required to assess the ability of their manufacturing process to produce a product that is safe for use in humans…

Biologics Production

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Facility Design for Contract Manufacturing

The number of mammalian cell-culture based products is increasing rapidly and has the potential to out-pace the current production capacity. New facility construction for mammalian cell culture production is costly and time consuming. Planning for initial product launch and long-term commercial manufacturing can be daunting for promising products in late phase clinical trials…

Biologics Production

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North Carolina’s Big Push Into Biomanufacturing

No state is losing more traditional manufacturing jobs than North Carolina, as its furniture, textile, and tobacco industries continue to decline with many companies going overseas for cheap labor. Manufacturing employment in the state has plunged by 140,000 workers during the last three years…

Biologics Production

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Outsourcing Molecular Biology Tasks: A Valuable Business Tool for Accelerating Bioprocessing R&D

A significant percentage of new pharmaceutical commercialization activities now focus on biological-based therapeutics. This increasing demand for biologicals necessitates the continued expansion and technological improvement of bioprocessing activities. Bioprocessing plays a critical role throughout the entire drug commercialization process…

Biologics Production

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Optimization and Flexibility: Enhancing the Pharmaceutical Supply Chain Through Strategic Warehousing

Optimization, flexibility, and competitive advantage normally aren’t used to describe warehousing operations in the pharmaceutical industry. However, as the industry continues to deal with difficult press, patent expirations, battles with Congress, and intense competition, even the historically unvarying business of warehousing is due for an overhaul…

Biologics Production

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Virtual Biopharmaceutical Sourcing: Six Methods for Six Sigma Outsourcing

Despite trepidations, bioprocess oursourcing has come a long way from its inception, which was born in necessity and regulatory fear. Based on primary research that Seraphim and Pharmsource conducted in 2002, the current market for biopharmaceutical manufacturing outsourcing (upstream and downstream production of bulk APIs, but excluding separately outsourced analytics, development, and other services) was $500 to $700 million with a projection to grow to $1.5 to $2.5 billion over the next five years…

Biologics Production

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Protein Production from Mammalian Expression Systems for Research and Early Development at Contract Facilities — A Primer

In the late research/early development stage of a biologic, it is often necessary to produce a larger quantity of a protein than a company is capable of producing internally. At this stage, the availability of the purified protein may govern its continued development. The protein needs to be produced with a minimal amount of waste; i.e., with a minimal amount of personnel and expense, in the shortest amount of time possible…

Biologics Production

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Outsourcing Clinical Trial Material Manufacturing: Regulatory and Quality Issues for the Twenty-First Century Biotechnology Product

The United States Food and Drug Administration (FDA) considers antibodies and recombinant proteins as “well-characterized products.” This is based on FDA’s comfort level with reviewing multiple products over an extended period of time. This designation relates to the product, not necessarily to the system that is used to manufacture the product nor to the facility where the product is manufactured. The initial guidance document was published in 1995, prior to the use of other systems and when the majority of products were still based on mouse hybridoma technology that was 20 years old…

Biologics Production

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Expanding Horizons: Opportunities in Eastern Europe for Contract Research Organizations

The contract research organization (CRO) industry is rapidly adapting to the exigencies of pharmaceutical and biotechnology companies. For a start, the function of CROs is no longer confined to offering only clinical trial outsourcing services. Instead, many CROs now provide a full complement of services that guide products from inception to commercial implementation…

Biologics Production

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Category: <span>Biologics Production</span>

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