2012

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…

EcoPrime

      LEWA developed its first pulseless pump for liquid chromatography in the late 1970s and delivered its first chromatography system in the early 1980s. LEWA is the leader in supplying pumps used for pilot and industrial HPLC, SMB, and LPLC chromatography worldwide. A customer came to us several years ago requesting a low-pressure liquid chromatography system with a flow range of 20–2,200 L/h. They also wanted the ability to achieve linear gradient from 1 to 99%. We designed…

Expression of a Self-Assembling Antigen-Targeting Fusion Protein

    Figure 1: ()   The Pfēnex Expression Technology™ platform is a very powerful protein expression technology based on the microorganism, Pseudomonas fluorescens. The Pfenex platform can deliver a robust production strain with unprecedented speed and a success rate that transcends legacy production hosts. Traditional recombinant protein expression hosts such as E. coli, insect cells, and yeast tend to have high failure rates regarding their ability to produce high titers of soluble, full-length, active target protein. In addition, the…

Commercial Prefilled Syringe Filling

The commercial prefilled syringe line at Cook Pharmica can process up to 600 syringes per minute, 36,000 syringes per hour, or 70 million syringes per year. The automated, high-speed syringe line is fully enclosed in a barrier isolator to provide the highest level of aseptic processing available by removing the human element from the entire process. With the ability to operate in smaller batches or full-scale campaigning, the prefilled syringe line is capable of bridging clinical programs into commercial production.…

POROS® HQ 50 and GoPure™ Prepacked Columns

      Anion-exchange (AEX) products are commonly used as a polish step in product flow-through (FT) mode to bind impurities. Comparing resins with membranes and membranes with membranes is challenging because of the complicated and unique scaled-down model formats of the products offered by different vendors. A novel approach to AEX FT using a short, 5-cm length, packed-bed format with a faster operating flow rate is explained. The performance of commonly used AEX resins and membrane adsorbers, detailing dynamic…