Considerations for Aseptic Bag Filling of API & ATMPs
Presented by: Ken Rando, COMECER
Tuesday & Wednesday 11am & 2pm EST • Thursday 11am only
Aseptic bag filling is a process that is very important to the biopharma industry. For the process, aseptic bag filling machines are used specifically. The technique of aseptic packaging is applied when sterilization of medical applications is not possible after the packaging step. This is very common for sensitive high-value biopharmaceutical products like Cell and Gene therapies (CGT). This presentation will give you the basics of aseptic bag filling, highlight the most critical factors of the technique and discusses key considerations pertaining to the commercial use of aseptic bags.
Biologics Manufacturing Using the Line of Sight Approach with PAT Enabled Equipment
Presented by: Zak Yusoff, Scientific Products
Tuesday & Wednesday 11:30am & 2:30pm EST • Thursday 11:30am only
Manufacturing biologics poses many challenges especially when these products are lyophilized. However, what is important to control and often not is the product temperature during the primary drying process. Freezing is key in lyophilization process which ultimately affect the product temperature. Controlling the product temperature during the primary drying phase dictates the quality attributes that your demonstrated during the development process. This presentation will discuss process analytical tools and technology you can employ during your commercial manufacturing process to aide you during scale up, routine manufacturing and show how the data can help in the event of process deviation.
Empowering Pharmaceutical Manufacturing with Precision, Speed, and Efficiency - PharmaScan
Presented by: Dan Cremer, ATS LSS
Tuesday & Wednesday 12pm & 3pm EST • Thursday 12pm only
The PharmaScan family of advanced inspection platforms is designed to meet the highest industry standards making us the go-to choice for leading pharmaceutical manufacturers. High-resolution cameras and optimal lighting are used to inspect the entire container and detect particles down to 50um while reducing false rejects. Whether you're dealing with liquid, lyophilized, or hybrid products in syringes, vials, or cartridges, PharmaScan has you covered with standard or custom options.