2013

Poster Presentations

Cell Culture and Upstream Processing Gary Boch (Cevec Pharmaceuticals) Custom Chemically Defined Media for CAP-T Cells Maurizio Cattaneo (BioVolutions) DoE for Continuous BioProcessing of Therapeutic Monoclonal Antibodies Stephanie Dubois (ATMI LifeSciences) Linear Scalability of Virus Production in Integrity®iCELLis®Single-Use, Fixed-Bed Bioreactors from Bench Scale to Industrial Scale Thomas Falkman (GE Healthcare) Assessment of Process Performance and Product Quality in High-Performing Fed-Batch Cultures Kathleen Harrison (Frieslandcampina Domo) Influence of Soy Protein Hydrolysates on Robustness of Cell Culture Experiments Clint Pepper (Bend Research)…

Upstream Chemistry Analysis in Cell-Based Process Development

Cell line selection is important to any pharmaceutical company’s development pathway for biological compounds (1). In cell-line selection laboratories, many different, slightly variable cell lines are tested in parallel for desired characteristics. Candidate cell lines are chosen for further development on the basis of their performance in basic tests of critical quality attributes (CQAs). Historically, such cell lines were selected in large-volume containers because it was necessary to have sufficient volume in culture to allow repeated sampling without damaging the…

Automation of Microbioreactors

Current methodologies in genetics and microbiology enable researchers to influence metabolic pathways of microbial cells in many directions. Beside the academic interest in investigating fundamental functions in metabolic pathways, commercial production of valuable compounds by microbial hosts is state of the art. For example, such products include enzymes (lipases, proteases, phytases), therapeutic agents (insulin, antibodies), bulk chemicals (lysine, glutamate, citric acid), or the microbial cells themselves (used in brewing or milk processing), with therapeutic agents probably the fastest growing market.…

Moving Forward with a Gene Therapy for Damaged Hearts

A cocktail of three specific genes can reprogram cells in the scars caused by heart attacks into functioning muscle cells. Adding a gene that stimulates the growth of blood vessels enhances that effect, say researchers from Weill Cornell Medical College, Baylor College of Medicine, and Stony Brook University Medical Center in a report that appears online in the Journal of the American Heart Association (1). “The idea of reprogramming scar tissue in the heart into functioning heart muscle was exciting,”…

Standards for Ancillary Materials Used in Cell- and Tissue-Based Therapies

Cell- and tissue-based therapies are being used increasingly to treat many diseases for which currently no other adequate treatment options are available. These products contain human or animal cells that can replace, regenerate, or augment a recipient’s diseased, dysfunctional, or injured cells, tissues, or organs. Cells or tissues might be unmanipulated, or their biological characteristics can be altered ex vivo before administration of the final product to patients. Examples of cell therapies range from traditional blood transfusions to recent approaches…

Upstream Processing

The “Cell Culture and Upstream Processing” track began many years ago as a conference of its own. In October 2004, IBC Life Sciences brought it together in Boston, MA, with three other events (“Recovery and Purification,” “Production and Economics,” and “Scaling Up from Bench to Clinic”) to create the first BPI Conference. Just like BPI magazine’s editors, the event producers have depended on industry advisors from the beginning. Our editorial advisory board (EAB) members give generously of their time and…

Bioprocess Specialists All Under One Roof

Setting its sights on the benefits to the customer, Eppendorf has steadily expanded its proven bioprocess technology portfolio since 2007. With the integration of New Brunswick™ and DASGIP®, Eppendorf combines its own expertise with the know-how of these renowned suppliers of bioreactors to set new benchmarks. For industrial and research users, this translates into sophisticated bioprocess software and hardware solutions from a single source that covers the full range from miniature bioreactor systems for R&D to production-scale, sterilize-in-place systems. The…

KANEKA KanCapAâ„¢

Protein A chromatography is still the preferred capture step in monoclonal antibody (MAb) production because of its high selectivity and robustness, although cation-exchange (CEX) or multimode chromatography techniques are claimed as alternatives. KANEKA KanCapA increases the value of protein A affinity chromatography for MAb production. Kaneka’s unique combination of a proprietary-designed alkaline stable protein A ligand and a highly cross-linked cellulose base matrix meets customer requirements for improved performance, high binding capacity, alkaline and chemical stability for cleaning in place…

Technology Transfer to a Contract Development and Manufacturing Organization (CDMO)

Technology transfer (TT), the transfer of technical know-how from a product sponsor company to a contract development and manufacturing organization (CDMO), is the cornerstone of a fruitful working relationship between the parties. It is critical for successful advancement of the sponsor’s product development and commercialization efforts. Having worked with more than 100 clients over 14 years, PCT has performed nearly as many TT programs, underscored by the key success factors listed below. Communication: Upon establishing a collaborative sponsor– CDMO staff…