September 2010

10 Steps for Choosing a Contract Manufacturer

    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…

Cell Culture and Production

    Time to market, cost of goods, and reduction of financial risk are major challenges in protein manufacturing. Process intensification can help biotech companies achieve their goals. Already underway in several other industries, implementing this concept shrinks production facility sizes by 10–1,000 times using novel processes and products (e.g., single-use and isolator technologies in biotechnology) to reduce capital and operating costs. The results can be safer, more energy-efficient, and environmentally sustainable manufacturing processes. For example, Gerben Zijlstra (senior scientist…

Putting It All into Perspective

    As part of The Automation Partnership’s “20 Years of Automated Cell Culture” series, science writer Sue Pearson interviewed Dr. John Birch, the chief scientific officer of biopharmaceuticals for Lonza Custom Manufacturing APIS based in Slough, UK. Birch has been with that company since 1996, Before that, he held senior technical positions at Tate and Lyle, GD Searle, and Celltech. Birch has a PhD in microbiology from London University, where he also spent a period lecturing before moving into…

Product Lifecycle Management

    Biopharmaceutical manufacturers have often explored the idea of real-time process control and monitoring — but until relatively recently, few case studies were available to help put all the information together in a coherent plan for true product lifecycle management. Shifting from previous BPI Conference programs that included a “scale-up” track, this year’s lifecycle track will reflect how companies are being encouraged to view development, design, and manufacturing as a continuum rather than (more “traditionally”) as a set of…

Influence of Process Development Decisions on Manufacturing Costs

    As we have discussed, cost has not always featured highly during bioprocess development, in which traditionally the focus was on product quality, regulatory compliance, and speed to generate material for the clinic (1). As the industry matures in commercializing successful products, increasing competition (both from competing products and biosimilars) leads to issues of cost and manufacturability coming to the fore. Solutions adopted will depend on each organization: At one extreme are small biotech companies developing novel therapeutic proteins;…

Speeding Vaccine Development and Production

    With infusions of public and private venture capital as well as technological advances, vaccine development is entering a new golden age as one of the fastest growing sectors in the biotechnology industry. In the 19th and 20th centuries, immunization programs eliminated or controlled infectious diseases including smallpox, polio, measles, mumps, and rubella. The biotech era has made significant changes both in the number of companies involved in vaccine manufacture and the production systems they use. BPI CONFERENCE SESSIONS…

Geographic Strategies in Biomanufacturing

In BPI’s June issue, we presented a supplement on geographical trends in biomanufacturing. We looked at the influence of a growing demand for biotherapeutics in emerging countries and the influence of new technologies that are driving interest in smaller, perhaps more geographically distributed production. We wanted to explore what a global bioeconomy would look like and where its primary capacity would be concentrated. Authors provided examples of how to balance cost with control issues. They talked about working in different…

Poster Presentations

Product Lifecycle Management Jayne Hesley, applications scientist in marketing for Molecular Devices, Inc. (Sunnyvale, CA) Homogeneous Antibody Binding Assay: Comparing Imaging Systems and Optimizing Acquisition Parameters for High-Throughput Screening Hybridoma cell lines are cultured to produce monoclonal antibodies for use in diagnostics, vaccine development, or therapeutics. One well-accepted assay for screening the antibody-containing supernatant of hybridomas is to capture the antibody on the surface of beads (

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

    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…

Minimizing the Environmental Footprint of Bioprocesses

    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…