biopharmaceutical – 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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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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Use of a Taguchi Parameter Design to Optimize the Propagation of Saccharomyces cerevisiae to Produce Bioethanol

The propagation of the yeast Saccharomyces cerevisiae was optimized using a Taguchi parameter design (TPD) L9(3 4) to produce bioethanol from an amylaceous material. The response factor selected was the specific growth rate of the yeast as calculated from the slope of the linear portion of its growth curve (neperian log cell concentration versus time). The reason is that the greater this rate, the higher the number of viable cells in the fermentation broth capable of ethanol production. The control factors selected were the initial amount of inoculum in the medium, the amount of glucose, the temperature, and the shaking speed which are the chemical and physical variables that most affect the growth behavior of this yeast. The noise factor selected was the initial peptone concentration in the medium. Statistical analysis and factorial split-plots indicate that the factor that most affected the response was the inoculum concentration (50.79% contribution), followed by the glucose concentration (25.22%), and shaking speed (14.79%). The contribution of temperature to the response variable was small (2.85%). This result was independent of the uncontrolled variation in the percentage of peptone in the sample…

Biologics Production

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Understanding the Fundamentals of Peptides and Proteins

With the strong growth in biologics, large molecules, and biopharmaceutical therapeutics in recent years, the pharmaceutical and biotech industries are increasingly turning toward peptides and proteins in the search for drug discovery targets. While both possess numerous properties that offer significant therapeutic potential, there are fundamental differences between the two compounds. This article examines some similarities and differences between proteins and peptides in light of potential market applications, manufacturing techniques, and the regulatory environment…

Biologics Production

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Prevailing Attitudes About the Science Profession

Back on March 13, 2009, this discussion question was posted to the Biotech and Pharma Professionals Network on LinkedIn: “What can industry do to encourage middle and high school students to pursue careers in biotech and pharmacology?” The response to this question was overwhelming. As of this writing, there are 1,467 comments posted. I have not read all of them yet. However, as a teacher of science at the high school level, I have been impressed by how involved network members have been by offering constructive suggestions to the industry intended to help encourage young students…

Biologics Production

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Quality Risk Management (QRM): Part I – Identifying, Evaluating, and Mitigating Threat Risks to Biopharmaceutical Enterprises

The FDA’s ICH Q9 quality risk management (QRM) guidance material is the foundation for understanding and evaluating patient risks associated with developing and manufacturing pharmaceuticals. This three-part paper describes approaches a team of subject matter experts (SMEs) can use for implementing two important applications of QRM. Part I provides a method for identifying and remediating threat risks that may affect the product’s quality or other important aspects of a manufacturing enterprise’s lifecycle, from product research and development to commercial manufacturing. The second QRM application covered in Part II manages patient risks by identifying, evaluating, and managing risks associated with process parameters (PP) on the product’s critical quality attributes (CQAs). The final paper, Part III, describes an approach for accepting or further mitigating the risks evaluated by the QRM exercise…

Biologics Production Guidance Mammalian Cell Culture Quality Risk Management (QRM) Regulatory Unit Operations

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