Author Archives: BPI Contributor

Perfusion! Jeopardy or the Ultimate Advantage?

In the past, perfusion methods were known to have high failure rates, but improvements in the technology have made perfusion more reliable. With newly improved technology and equipment, perfusion is now an efficient manufacturing process with the ability to reduce the cost of goods and capital investment required to bring a drug to market. In this on-demand educational webcast, Dr. Jason N. Carstens of CMC Biologics discusses:

• A Comparison Between Perfusion and Fed-Batch Methods
• Detailed Description of Perfusion Operations
• Advantages and Challenges of Perfusion

Join Dr. Carstens as he displaces old myths about perfusion and shows how this method of manufacturing can actually produce proteins that have more desirable product efficacy and safety profiles than would be possible with the fed-batch method.

Using Innovation to Drive Competitive Advantage

    Figure 1: () STOCKXPERT (WWW.STOCKXPERT.COM) After spending decades as the “sleepy†segment of the biopharmaceutical industry, vaccines are now seen as one of its highest growth segments. Major pharmaceutical companies — Novartis AG (www.novartis.com) and Pfizer, Inc. (www.pfizer.com), for example — are aggressively entering this area. Those already in it are expanding capacity and increasing business development activity. Indeed, access to the vaccines business was a major driver of Pfizer’s acquisition of Wyeth Pharmaceuticals (www.wyeth.com) (1). Several factors…

Global Marketplace

        Automated Chromatography   Product: Tecan Freedom EVO liquid handling workstation Applications: Resin and condition screening, bioreactor monitoring, sample preparation Features: Atoll RoboColumns miniaturized columns are prepacked with a resin of choice in a 96-array SBS format and integrated on a liquid handling robotic workstation. Eight columns are processed together for highly reproducible chromatographic separations. Fraction volumes ≥25 µL can be collected, providing sufficient data points to construct a chromatogram. The entire process can be automated, from…

Althea Technologies, Inc.

While CMOs have traditionally been used to play a critical role in the manufacture of drug product, Althea has evolved beyond being a role player to a strategic development and manufacturing partner that can drive value to a client’s product or product candidate. As drug development costs are always increasing, a properly integrated development and manufacturing scheme can significantly decrease development time and expense, while increasing the probability of clinical success and product differentiation. To allow clients to leverage such…

Avecia Biologics: Development Expertise. Manufacturing Excellence

    Adedicated contract manufacturing organization supporting the biotechnology and pharmaceutical industries from preclinical process invention to postlaunch, commercial scale manufacture. Avecia’s industry-leading expertise enables customers to improve the cost-effectiveness and profitability of new therapies, while maintaining fast-track progress into, and through, its clinical development program.   Process Development and Scale Up   Avecia’s experience ensures process development is applied appropriately dependent upon the development needs of customer products at different clinical stages. Expression in E. coli and yeast, including…

A State-of-the-Art Facility Uses Disposables and Stainless Steel

Baxter Bioscience’s Hayward CGMP manufacturing facility offers dedicated capacity backed by 15 years of experience in developing and manufacturing monoclonal antibodies and recombinant proteins. We offer the firepower you need at any stage of development. Our goal is simple: to advance your biologic at any step — from preclinical to commercial — in the most timely and cost-effective manner possible. This state-of-the-art, licensed facility is located in the premier Biotech Bay for fast and flexible service. Just under 30 miles…

Boehringer Ingelheim: From Mind to Market

      The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since its foundation in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing innovative products of high therapeutic value for human and veterinary medicine. Our therapeutic areas are respiratory, cardiovascular, central nervous system, urology, virology, rheumatology, metabolism, immunology, and oncology. Boehringer Ingelheim is one…

Biopharmaceutical Product Development

Catalent Pharma Solutions offers a total solution for the development and manufacture of biopharmaceutical and sterile products. Our proprietary technology — and expertise in working with proteins, peptides, and other biotechnology-derived active materials and small molecules — helps maximize the potential of your API and accelerate your product’s speed to market. From cell line engineering to manufacture of API and drug product for clinical trials, our team of highly experienced protein chemists, biochemists, pharmacists, and pharmaceutical scientists provides the exceptional…

Designing, Developing, and Delivering Our Clients’ Biopharmaceuticals

      Eden Biodesign is a globally integrated biopharmaceutical and vaccine contract biomanufacturing company. We are an expert provider of consultancy, biopharmaceutical process development, and CGMP manufacturing services. Our rarely found blend of experience and expertise, gained from providing services to a worldwide client base, ensures that the clinical medicines we develop are regulatory compliant and optimally positioned for further clinical and commercial development. Our state-of-the-art facility in Liverpool, UK, is licensed to produce clinical products, which is best…

A Team of Experts

  Who We Are     Based in Grenoble, France, PX’Therapeutics (formerly known as Protein’eXpert) is a contract research and manufacturing organization devoted to the development of biotherapeutics. Our 50-person staff offers custom-designed services ranging from recombinant protein and monoclonal antibody discovery and optimization up to clinical cGMP manufacturing for preclinical and clinical studies.   Acknowledged Scientific Expertise   We have demonstrated our high level of expertise in protein science and our capability to tackle complex and recalcitrant projects. We…