Today Paschal Iwuh’s new article “Commissioning & Qualifying: Facility Considerations for Tissue Engineering” has published in three online magazines: Cell & Gene, BioProcess Online, and Outsourced Pharma.

Paschal’s article compares the methodology for equipment and process validation used for a conventional bulk drug substance biotech facility with a personalized medicine tissue engineering facility. Because this area of biotechnological innovation emphasizes cell manipulation, the equipment, systems, and material methods for a state-of-the-art tissue engineering facility are markedly different from a conventional biotechnology facility.

Dr. Iwuh explains how commissioning and qualification (C&Q) activities are conducted and details the validation costs attributable to each type of facility. To determine the costs and types of validation methodology needed for each facility, future operators or owners should understand the main differences.

Click to read or share the links below.
https://www.cellandgene.com/doc/commissioning-qualifying-facility-considerations-for-tissue-engineering-0001