Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Page 43 of 61

44 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m Fill/Finish A s t he needs for asept ic pa rentera l d r ug produc t ma nufacturing cont inue to evolve w it h adva nce- ments in technology and ever increasing regulatory scrutiny, parenteral packaging component suppliers must a lso innovate a nd develop solut ions to add ress t hose increasing needs. The portfolio of the drug product pipeline within many pharmaceutical companies has also shifted from la rge-volume " blockbuster" dr ug products to sma l l-volume "patient-centric" precision therapeutics. The historically acceptable "open processing area" filling lines w it h limited or no barrier technolog y is becoming obsolete. The use of restricted access barrier system (RABS) and isolator barrier technology has increased exponentially, and within the past f ive years, nearly ever y f illing line being built is within barrier technology. An additional shift occurring throughout the industry is the execution of many smaller batch f ills resulting in the need to change operational logistics and practices. The acquisition and use of f lexible fillers has greatly expanded to meet this need. A f lexible filler is a small-scale filling line designed to be able to process multiple container formats, such as vials, cartridges, and syringes, while only requiring limited change part modifications for each respective container type. I n re s p on s e to t he s e i ndu s t r y t rend s , m a ny pa renter a l packaging component suppliers are expanding their ready-to-use Ready-to-Use Parenteral Packaging Components Address Evolving Aseptic Fill/Finish Requirements Simon Cote Ready-to-use components eliminate the need for component preparation by the drug product manufacturer, enabling them to streamline their processes and focus on their core competencies (drug product development and manufacturing). Simon Cote is a principal engineer, Technical Customer Services, West Pharmaceutical Services, Inc. MACONDO/SHUTTERSTOCK.COM

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