November 14, 2017
Senior Consultant Igor Gorsky has been published by Contract Pharma. Gorsky’s article, “Sterile Manufacturing Future Trends and Challenges” addresses the biotechnology market’s unprecedented growth and the need for contract manufacturers to update their facilities with new technologies that increase efficiency and compliance.
“Sterile product manufacturing facilities are aging,” Gorsky commented. “While some firms are keeping their facilities current so that new generations of products can be manufactured with fewer risks and interventions, many are not.” He continued, “While reviewing recently issued FDA Forms 483 and Warning Letters, we are finding many firms are not up to par and compliant with elementary aseptic practices….
November 9, 2017
Mike Long, Senior Director of Consulting Services, is a recent contributor to BioProcess Online. Long’s article, “A Line-Of-Sight Approach To Continued Process Verification Planning” addresses the importance of planning for continued process verification (CPV) at the onset of product development. This occurs only when one understands important product and process attributes that must be monitored during the product’s life span.
“Any discussion of CPV planning must begin at Stage 1, process design,” Long commented. “It does not matter if the planning is for a new product, a tech transfer, or a legacy product….