11.30.16
Ajinomoto Althea’s director of fill and finish manufacturing, Paul Ruther, talks about some of the key industry and technology trends impacting today’s aseptic fill and finish market.
Contract Pharma: What pharma/biopharma macro trends are you seeing and how are they trickling down to impact aseptic fill/finish operations?
Paul Ruther: The biggest trends we are seeing that affect aseptic fill/finish operations are the ever-tightening regulatory demands. They are trickling down in forms of tightened particulate requirements, the need for PUPSIT (Pre-use Post Sterilization Integrity Testing), and the increasing push to isolators.
CP: What are the most important trends in fill/finish outsourcing today?
PR: For outsourcing, the markets for biosimilars and the need to push products quickly into stability batches, process validations, and commercialization are ever increasing. ADCs, high potency antibody drug conjugates, are also trending upward.
CP: How would you describe the cu
Contract Pharma: What pharma/biopharma macro trends are you seeing and how are they trickling down to impact aseptic fill/finish operations?
Paul Ruther: The biggest trends we are seeing that affect aseptic fill/finish operations are the ever-tightening regulatory demands. They are trickling down in forms of tightened particulate requirements, the need for PUPSIT (Pre-use Post Sterilization Integrity Testing), and the increasing push to isolators.
CP: What are the most important trends in fill/finish outsourcing today?
PR: For outsourcing, the markets for biosimilars and the need to push products quickly into stability batches, process validations, and commercialization are ever increasing. ADCs, high potency antibody drug conjugates, are also trending upward.
CP: How would you describe the cu
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