Sterile Manufacturing Future Trends and Challenges

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. They need to be, and soon. By the middle of this century, biopharmaceuticals are set to overtake all other pharmaceutical sales and become a therapy of choice for new generations.”

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igorIgor Gorsky is currently senior consultant at ConcordiaValsource, LLC. He has held multiple positions with increasing responsibility at several pharmaceutical companies, working in production, quality assurance, technical services and validation, as well as heading up global pharmaceutical technology validation. He can be reached at