Wednesday, July 1, 2009 Daily Archives

Improving Peptide Mapping

Figure 1: Peptide mapping is the workhorse technique in biopharmaceutical analysis, offering the comprehensive characterization of biopharmaceutical products. Its applications include the identification of proteins based on the elution pattern of peptide fragments, the determination of posttranslational modifications, the confirmation of genetic stability, and the analysis of protein sequences when interfaced to a mass spectrometer. In a typical peptide mapping workflow, a protein is first digested with trypsin or other protease to generate peptides, which are separated by liquid chromatography,…

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…

Tuning Oxygen Transfer in Small-Scale Fermentors to Mimic Manufacturing Productivity: A Case Study

Figure 1: An appropriate fermentation scale-down model is critical to allow comparison of lab scale studies to the manufacturing case. Modeling of fermentors increases confidence that a fermentation process is scalable within the confines of available equipment and that the data acquired are an accurate representation of production fermentations. Modeling fermentation oxygen transfer between development scales of 1–100 L and production scales of 1,000–10,000 L+ has been extensively studied, and there are numerous approaches including P/V, KLa, and OUR models.…

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…

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…

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…

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 Dedicated Contract Development and Manufacturing Organization Focusing on the Delivery of Advanced Biologics for Customers Worldwide

Angel has provided contract development and GMP manufacturing services for recombinant proteins, antibodies, and vaccines since 2001. Responding to market demand, Angel has also built an impressive track record delivering advanced (live) biologics comprising cell therapies including stem cells, cellular vaccines, and bacteriophages. Angel is one of very few European companies providing specialist GMP manufacturing support of these products for international clients. Comprehensive Solutions Angel offers vertically integrated manufacturing solutions reducing risk, cost, and timelines for clients. We believe that…

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…

Risk Mitigation and Quality by Design (QbD) Enhancement Through Raw Material Characterization

Interruptions in bioproduction pose serious setbacks for biopharmaceutical companies. Shipping delays, performance variability, quality unknowns, and regulatory issues can delay time to market and ultimately depress a producer’s financial results. Unforeseen variability in process parameters has led the US Food and Drug Administration to insist that biopharmaceutical manufacturers find ways to ensure batch quality of a drug product during manufacture without relying solely on finished product characterization. This challenge is daunting, considering the large number of raw materials required for…