Berkshire Sterile Manufacturing (BSM), a Massachusetts fill finish CMO, and Aptar Pharma, a global leader in drug delivery systems, services and active material science solutions, will discuss what matters in selecting a container and closure system for sterile injectable drug products in a webinar entitled, “Why your container and closure choice matter in sterile fill finish,” on January 18, 2023. The two companies are teaming up to provide clarity and direction for pharma and biotech companies with drug candidates in clinical trials.
Companies with a parenteral in clinical trials must eventually commit to a particular GMP-manufactured container and closure system for their product for their FDA filings. However, settling on a container closure system is not a trivial nor a simple decision. The vial, syringe, cartridge, stopper, or plunger that’s selected has important implications for the drug product it carries.
During the webinar, the Aptar Pharma injectables team will discuss how container closure systems affect product stability, drug efficacy, and administration, and they will present what new and improved container closure systems are hitting the market. BSM will advise on how to avoid supply chain shortages, where substitutions can and cannot be performed, and how to determine which CMO and vendor to partner with to develop a successful drug product supply chain.
The webinar is free to attend, and you can register for the webinar here: https://berkshiresterilemanufacturing.com/events/webinars/sterile-filling-101/episode-6/
Arnaud Fournier, Regional Market Development Manager, and Sébastien Cordier will speak on behalf on Aptar Pharma, and the speakers from BSM will include Project Management Manager, Steven Gaertner and Process Engineering Manager, Dr. Jake Krans.
About Steve Gaertner:
Steve Gaertner leads the project management department at BSM and oversees all client projects and their timelines and production scheduling. In the past year alone, he has advised over 60 active clients in their production, including addressing component and container related concerns such as supply limitations and product incompatibility.
About Jake Krans:
Process Engineering Manager, Dr. Jake Krans, and his team addresses component compatibility concerns with BSM’s sterile filling lines. He creates solutions to ensure the fill process is optimized for each project’s unique components, container, and drug product so filling is efficient and effective.
About Arnaud Fournier:
Arnaud Fournier is the Senior Regional Market Development Manager for Aptar Pharma’s Injectables division. Arnaud graduated from IPAG Business School Paris where he specialized in marketing. He joined Aptar Pharma in 2004 as a Marketing Project Manager in charge of marketing studies, in 2013 he became a Business Support Manager and progressed in 2018 to Senior Business Manager for Aptar Pharma’s range of elastomeric components for vials, pre-filled syringes and PremiumCoat® range of coated solutions. In his current role since 2019, Arnaud leads the development of the North American market and Service offering for Aptar Pharma.
About Sébastien Cordier:
Sébastien Cordier is the Technical Product Manager for PremiumCoat® projects at Aptar Pharma’s Injectables division. A graduate of MINES ParisTech and EDHEC Business School in France, Sébastien first spent over 15 years in the automotive industry, where he developed a strong expertise in plastics and elastomers, before joining Aptar Pharma in 2020. In his current role as Technical Product Manager at Aptar Pharma, Sébastien is responsible for the PremiumCoat® platform of vial stoppers and syringe plungers, and is dedicated to supporting customer development projects involving coated elastomeric solutions.
About Berkshire Sterile Manufacturing:
Berkshire Sterile is a state-of-the-art fill finish contract manufacturer that is specialized in small-scale sterile filling of vials, syringes, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, and lyophilization of vials all within isolators. Analytical support, stability studies, lyophilization development, formulation development, and method development are also offered. For more information, please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact them at firstname.lastname@example.org.
About Aptar Pharma:
Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions and services. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home care, food and beverage. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.