August 2012

Culture of Normal Human Dermal Fibroblast Cells

      The large numbers of ex vivo expanded cells that are required in many clinical cell therapy protocols (>100 million per patient) make standard culture conditions problematic and expensive, resulting from the need for extensive personnel and facilities resources and the high potential of contamination. To meet such clinical demand, a robust, automated, and closed cell-expansion method is optimal. The Quantum Cell Expansion System (CES) is a functionally closed, automated, hollow-fiber bioreactor system designed to reproducibly grow both…

Constraints on Vaccine Production

      Influenza vaccine has historically been produced in embryonated chicken eggs. However, to meet the needs for pandemic preparedness and the scalability of vaccine production, cell-based processes are now being developed and implemented in the industry. The methods for purification processes have typically involved a combination of sucrose density gradient ultracentrifugation, ultrafiltration/diafiltration (UF/DF) with hollow-fiber membranes, and chromatography using affinity, ion-exchange, and/or gel filtration media (resins). In these processes, both sucrose density gradient ultracentrifugation and gel filtration have…

Intelligent Tools to Facilitate Bioprocess Development

    Figure 1: ()   Continously new bioprocesses are evolving, and bioprocessors are searching for the easiest way to process samples in R&D. Currently, a huge trend toward disposable production systems is notable. For these purposes plastic bags, stirred tank reactors, and storage tanks established on the market. Unfortunately, these reactor types are not suitable to perform sophisticated bioprocess development. In bioprocess R&D, throughputs of 50 to 1,000 fermentations are needed. Therefore, m2p-labs developed intelligent new tools at microscale…

Scalable Packaging Systems for Cell Therapy

Daikyo Crystal Zenith® vials provide an ideal solution for low-temperature or cryogenic storage and transport of high-value biological drugs. () Many current cell-based products are produced, frozen, stored, and delivered to the clinical site in intravenous (IV) bags or polypropylene screw-cap containers. Although IV bags are sufficient for small-scale processes, they may not be suitable for commercial scale. Bag failures can lead to microbial contamination of the cell product, increased product preparation time, increased antibiotic use, and increased resource expenditure…

Platform Approaches for the Purification of Antibody Fragments

    Figure 1: ()   Antibody fragments (e.g., Fab, scFv, DAb, etc.) are set to become the next important class of protein-based biotherapeutics after monoclonal antibodies (MAbs). One of the advantages is that due to their structure and smaller size, antibody fragments possess unique properties (e.g., easier tissue penetration) that suit a range of diagnostic and therapeutic applications. The industry standard for purifying MAbs is a platform approach using affinity chromatography with protein A as the capture step. The…

ActiCHO Media System

      We have previously reported rapid, consistent, and highly productive fed-batch processes from shake flasks to 5-L glass and 200-L single-use bioreactors using the ActiCHO Media System (1). This system has demonstrated to be highly reliable in many processes using different Chinese hamster ovary (CHO) cell clones. PAA Laboratories/GE Healthcare manufactures this medium in both liquid and powder formats and supplies it worldwide for large-scale applications. Here we present some data on industrial scale-up studies going directly from…

Althea Technologies, Inc.

      Althea is a contract developer and manufacturer of biopharmaceutical and injectable products with fully integrated product development and cGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at Althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach, or just the parts you need. While realizing all of the tangible benefits of consolidating your development and manufacturing steps, you’ll also have…

Kaneka Protein A Cellulose

      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 Protein A Cellulose 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…

PROPOR MR

      Microbial contamination of cell cultures is a major process risk that leads to lost production batches with considerable economic impact for a biopharmaceutical manufacturer. Incidences of penetration of typical 0.2-µm sterilizing-grade membranes by mycoplasma species have led to higher-retention 0.1-µm–rated filters becoming commonplace for filtering mammalian cell culture media.   Increasing Retention without Slowing Down Processing   There are a number of 0.1-µm–rated filters available, and although many are effective at removing mycoplasma contamination, the tighter filtration…

BioPharma Solutions

      BioPharma Solutions, a business unit of Baxter Healthcare Corporation, works with pharmaceutical companies to support their commercialization objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face.   Meeting Parenteral Manufacturing Challenges   Parenteral manufacturing can be a complex process. Cytotoxics, antibody-drug conjugates (ADCs), highly potent compounds, biologics, and lyophilized products require specialized understanding. BioPharma Solutions offers a dedicated facility with experienced…