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,…

      Rentschler Biotechnologie GmbH is a full-service contract manufacturer with over 30 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards with a highly skilled staff of 450. As part of the Rentschler Group and headquartered in Laupheim, Germany, Rentschler is one of three leading European CMOs operating globally. Dedicated to delivering high-quality biopharmaceuticals produced in mammalian cell culture, Rentschler has nine stand-alone GMP suites with volumes of 30 L,…

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…

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…

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…

    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…

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…

      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…

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…

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.…