Berkshire Sterile Manufacturing (BSM), a Massachusetts contract development and sterile manufacturing company, will describe how sensitive drug products are handled during the fill finish process in a webinar on March 15th.
As more complex, large-molecule biologics and other therapeutics enter the market, the demand for protecting products that are sensitive to temperature, light, and shear grows. BSM hopes to help sponsors with sensitive drug products, such as biologics, AAV and oligonucleotides, understand the options available to them to protect their product during formulation, filling, storage, and distribution.
BSM will cover topics such as how to keep drug products cool while formulating and filling in ambient cleanrooms, how to protect light sensitive product during formulation and filling, and how filtration and pumping actions affect shear-sensitive products.
On March 15, BSM will discuss a typical fill finish process and implications for sensitive drug products. They will also describe modifications that can be made to protect shear, light, and temperature-sensitive drug products, and what happens after the product leaves your fill finish site. BSM will also detail options available to sponsors to protect their sensitive drug product.
The event, Aseptic filling of unstable drug products, is free to attend, and those interested can register for the webinar here: https://berkshiresterilemanufacturing.com/events/webinars/sterile-filling-101/episode-7/
Takeaways will include:
- What a typical sterile fill finish process looks like and implications for sensitive drug products
- Formulation and filling techniques and the best practices for protecting sensitive drug products
- What to expect after your fill: storage, labeling, packaging, and distribution for sensitive drug products.
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.