Ensure EU GMP Annex I compliance while maintaining sterile injectable manufacturing excellence & agility

Prefilled syringes are an integral part of a complex ecosystem governed by industry regulations. The process of filling the primary container is crucial for ensuring that safe and effective products are provided to patients. When introducing a new drug delivery system, a unique value offering helps differentiate from the array of products in the market. A complete PFS solution, designed and verified as a system rather than out of individual constituent parts, can be highly beneficial. The challenge is how CDMOs and component manufacturers can simplify the development programs for prefilled syringes (PFS) and combination products while upholding evolving regulations and their interpretations.

In the realm of sterile manufacturing, the quality culture, especially how it addresses change, serves as the best predictor of real-world performance. A strong history of inspections coupled with a transparent process for addressing findings is essential as we move beyond Annex 1.

How will suppliers and contract development and manufacturing organizations (CDMOs) embrace these new standards to continue providing exceptional value to their partners and patients?

Join us to discuss factors in sterile fill-finish and prefillable syringe systems that can influence your product's success and reduce your time to clinical fill.

First name

Last name

Company

Job Title

Country

ZIP/Postal Code

No cost to register, subject to confirmation

By registering for this event, you accept that you may receive direct communication from Endpoints News and/or the sponsor(s). View how we use your data here.

If you are experiencing problems with your registration, please try the Zoom registration page.

Mary Lou Glotzbach

Sr. Manager, Drug Delivery Partnerships, Grand River Aseptic Manufacturing

Mary Lou Glotzbach has decades of CDMO industry experience, focusing on partnerships in pharma and biopharma, as well as aseptic manufacturing and packaging programs. She is passionate about developing and executing strategic partnerships that provide value to all parties involved. Before joining GRAM, Mary Lou held various business development and marketing roles at notable CDMO organizations, including Abbott Laboratories, Hospira, and Pfizer. Mary Lou earned a B.S. in Biomedical Engineering from the University of Iowa and has completed executive programs at Kellogg and Wharton.

Bettine Boltres

Director, Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services

Dr. Bettine Boltres is a recognized thought leader in the industry, fostering scientific exchange between West and the pharmaceutical sector. She possesses extensive knowledge in glass, polymer, and rubber materials, which carries over in her expertise in combination products. Dr. Boltres is the author of the book “When Glass Meets Pharma” and serves as an expert for the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and various ISO working groups. Additionally, she plays an active role in the Parenteral Drug Association (PDA) and is serving on the PDA Board of Directors since 2019.