where innovation meets sterile manufacturing
This webinar series was created to help guide you through some of the more complex and difficult areas of sterile filling. Our ultimate goal is to provide you with the know-how to get your drug through production and to your patients as quickly, efficiently, and safely as possible.
For many pharmaceutical and biotech companies entering preclinical and clinical studies, their formulation is still in development. While most have prepared the formulation in their own lab, developing a formulation for sterile fill finish is a different challenge requiring different information. How do you scale up your formulation? Can your product be sterile filtered? How do you maintain homogeneity in suspensions? Is the drug product compatible with the vessel and tubing selected? How soon in advance does the drug product need to be prepared for filling activities? What equipment is needed in your formulation?
In this webinar, we describe how your CMO can help develop and scale-up your formulation. We will also discuss supporting studies and tests that can be performed to determine your equipment requirements and build your formulation process, and what information you will need to know before you contract with and fill finish CMO.
Wed, September 13, 2023
1 PM EST
Berkshire Sterile Manufacturing
Wed, September 13, 2023
1 PM EST
where innovation meets sterile manufacturing
Berkshire Sterile Manufacturing
This webinar series is the culmination of information from several industry leading vendors and a leading CMO working together to build an innovative state-of-art filling line. The information provided in this webinar series is unique and unattainable elsewhere.
Saran Malhi, PhD
Associate Director of Formulation and Tech Transfer
BERKSHIRE STERILE MANUFACTURING
Xufeng Sun, PhD
Vice President of Technical Operations
BERKSHIRE STERILE MANUFACTURING