A global CMO for medical media
Whether for basic research, drug discovery, or therapeutic applications, stem cell differentiation requires standardised culture methods to ensure reproducible and reliable results. To support stem cell research and production, Biological Industries (BI) offers a specific set of xeno-free, animal-free cell culture media, stem cell reagents, and protocols. This evolving product portfolio offers a powerful base to support researchers in culturing, reprogramming, characterising, and differentiating stem cell colonies. From identifying colonies and their lineages to monitoring changing morphology, BI’s stem-cell products are accelerating researchers’ quest to understand disease processes.
BI is dedicated to site alignment and production processes which allow clients to confidently use BI as their sole supplier of medical cell media products. Extensive experience in liquid manufacturing and packaging makes BI an excellent partner for companies moving their products from the laboratory and pilot-scale to full-scale production. BI scientists, equipped with their latest technologies, are available to offer direction on cell line, media, and process development challenges. The BI team will identify the best available medium and is able to scale-up to a commercial level within a short period of time. BI can be a reliable outsourcing partner to expand its clients’ capabilities. Though almost any of the current catalogue cell culture media formulations can be adjusted to create a customised cell culture medium, BI’s media development and optimisation services are clearly focused on stem cell product development. BI’s tailored services include: sterile filtration and aseptic filling, flexible packaging in industrial single-use (bulk) bags from 0.5 to 2000 litres, pilot-scale freeze drying (lyophilisation), and an extensive range of Quality Control services.
Quality standards are crucial
As a manufacturer for the life science industry, Biological Industries is fully committed to the current Good Manufacturing Practices (cGMP) comprising local law, as well as international guidelines adopted by the U.S. Food and Drug Administration (FDA) and by the European Medicines Agency (EMA). BI’s quality systems comply with the international standards for Quality Management Systems as defined by the ISO 13485:2003 and is routinely audited by accredited external bodies. Their manufacturing facility is an ISO 9001:2015 and ISO 13485:2003 certified facility and their controlled-environment clean rooms are graded from ISO 8 up to ISO 5 (classified from class 100,000 to 100). Products are divided into two groups: ‘For Research Use Only’ and ‘For In Vitro Diagnostics’.
First published in European Biotechnology Magazine, Sumer 2018 Edition