Figure 1. Albumin is used in cell culture media as a replacement for serum because of its positive effect on cell growth and productivity (1,2,3). Albumin is a known transporter of nutrients, lipids, and it removes toxins and waste products (2,3). Albumin is a classic performance-enhancing ingredient in many serum-free media formulations (1). However beneficial, plasma-derived albumin is undesirable because animal products present potential contamination by infectious agents. Cellastim™ recombinant human serum albumin is an animal-free albumin specifically developed for…

Figure 1. With over 60 years experience in microbial protein expression, Novozymes offers a range of animal-free recombinant supplements — designed and manufactured exclusively for industrial cell culture — that allow developers to “rethink” their media strategy. These products provide proven performance benefits in a defined and regulatory-compliant manner, ensuring optimal media development for enhanced cell productivity. Recombinant Human Albumin (rHA) Novozymes has developed a range of rHas (Recombumin®, albucult™, and CellPrime™ ralbumin AF-S) suitable for industrial cell culture and…

Figure 1. Fed-batch versions of stirred-tank cell culture have become most popular at large scales. The primary driver of a mid-run addition of nutrients to batch cultures is to increase the quantity of product harvested. The prevalence of fed-batch over other modes is attributable to many practical factors such as reliability, scalability, and application latitude. Increases in the integral of viable cell concentration and volumetric productivity are commonly the greatest improvements obtained (1). Factors determining optimum feeding of cultures include…

SAFC Biosciences views supply chain management as a structured process that seeks to evaluate, monitor and control supply chain risk, safeguarding continuity while maximizing profitability for its supply chain partners. Successful supply chain management in the biopharmaceutical industry is no longer simply a case of having the right material in the right place at the right time to guard against production delays. Today, the basis of our supply chain offering includes risk mitigation, robust supplier relationship management and critical raw…

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…

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…

Whether applied to business security, product specification, financial exposure or personnel safety, quality is a key element underpinning any biopharmaceutical risk mitigation strategy. A quality system should not be inherently dependent upon personnel, nor should it rely solely on people to ensure the quality of the products manufactured. Irrespective of human resources, the system itself should provide consistency, addressing risk from design inception through to product delivery, ensuring that robust processes are in place that minimize risk to the product…

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…

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…