The covalent attachment of polyethylene glycol (PEG) to a therapeutic protein is frequently used to increase the half-life of that protein in patients while reducing their immunogenic response. The PEGylation reaction can be optimized to maximize the desired product (average moles of PEG per mole of protein) molecules while limiting undesired byproducts (under- and over-PEGylated species). In the example discussed here, the desired molecule was mono-PEGylated, yet the preoptimized reaction yielded multi-PEGylated species visible by SDS-PAGE. The goal of our…

With expansion of production capacity, range of services, and customer base, CMC continues to grow. Earlier this year, CMC acquired the former ICOS Biologics development and manufacturing facility in Seattle, WA, from Eli Lilly. Now known as CMC ICOS Biologics, this facility focuses primarily on mammalian production, and during 2008 it is being upgraded to enable production of in-market biopharmaceuticals as well as late-stage clinical trial material. Dr. Gustavo Mahler, previously with Bayer Healthcare, has been appointed president of CMC…

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 to 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 provide the…

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and nearly 39,800 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 of the…

Figure 1. Integrating production processes within a complete facility does not always lead to a costly execution and long time to market for end users. This is what a specialist company such as Boccard can offer thanks to its expertise in process design and construction of pharmaceutical GMP systems, and thanks to a different project implementation strategy that focuses on the client’s core business, production needs, and operating methodologies. Case Study: Alpha Biologics Facility Project in Malaysia Present in 20…

The biopharmaceutical industry is faced with a challenging task: planning, developing, manufacturing, and bringing to market a highly specialized and complex biopharmaceutical product. Competitive pressures, cost, and — above all — time to market are of key concern. The wide range of implementation options, from in-house resources to outsourcing companies of various calibers and capabilities, adds yet another layer of complexity to the decision-making process. Our objective is to offer our customers a full-service alternative to the development and manufacturing…

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, their clinical development programme. Process Development and Scale Up Avecia’s experience ensures that process development is applied appropriately dependent upon the development needs of customer products at different clinical stages. Expression in E. coli and yeast, including Pichia pastoris and Saccharomyces cervisiae Wide range of constructs and expression options including developing a customer’s existing system or creating one de-novo…

Figure 1. Effectively working with a contract manufacturer’s project management team to ensure project success is a key goal for not only Althea Technologies, but for all companies working on difficult and complex manufacturing projects. Project management tools are widely used to effectively manage biotechnology and pharmaceutical product development. Implementing a project management office (PMO) is still a challenging undertaking for a contract manufacturing organization that has a wide array of project requirements to address. There are a number of…

i3 is a global business providing integrated scientific strategies and solutions throughout the biopharmaceutical product lifecycle. Its combination of products, services, and knowledge helps companies gain sharper insights that lead to better patient care. i3 Research i3 Research is a full-service clinical research organization (CRO) focused in cardiology, central nervous system, endocrinology and metabolic disease, oncology, and respiratory and infectious disease. Therapeutic specialization drives all aspects of this group’s business — from project staffing and talent management to quality initiatives,…

For more than 25 years, Invetech has been at the forefront of breakthrough product development and automation. Today we are as recognized for our unique approach as for the resulting commercial successes. Working with ambitious start-ups through to successful global businesses, our specialist expertise in design, engineering, and manufacturing enables us to deliver solutions that are as practical as they are marketable. Our award-winning portfolio has led advances across medical, industrial, and consumer markets, enabling clients to forge new ground…