Newsletter | April 29, 2021

04.29.21 -- Data-Driven Lyophilization Process Shortens Time To Market

How Scale-Up Benefits A Clinical Program To Get Results

A scalable manufacture promises increased process understanding and manufacturing flexibility to deliver a robust, reliable commercial product, and it helps with timely delivery to market, a competitive advantage for gaining market share.

3 Key Considerations When Choosing A Partner For Your Tech Transfer

Transferring pharmaceutical production between sites can bring many advantages. One way to streamline tech transfer is to partner with a CMO demonstrating a proven track record across the entire drug development and manufacturing continuum.

Advantages Of Working With An Embedded CMO

With specialized resources and facilities, backed by a wealth of expertise, the right CMO can expedite market launch for timely delivery of essential drugs to the patients who need them most. An embedded CMO offers many advantages over other CMO models, not least of all its access to the extensive capabilities and know-how of the parent organization.

The Value Of Expertise In The Aseptic Fill Finish Of Biologics

Aseptic fill finish manufacturing is especially critical for highly valuable biologics drug substances, since with vast amounts of time and resources invested upstream, any errors resulting in loss of product at such a late stage can be catastrophic.

Onshoring Pharmaceutical Manufacturing: Find The Right CMO

When drug and API manufacturers decide to make the shift to bring production back to the U.S,, they should be prepared with a well-designed quality system and a thorough tech transfer process. Partnering with the right CMO will ensure a smoother transfer.

Shorten Time-To-Market With New Data-Driven Lyophilization Process

The use of computational fluid dynamics (CFD) for modeling development, advanced analytics, and state-of-the-art GMP lyophilization equipment enables better understanding of the process and reduces the time required for optimization of robust, scalable lyophilization processes.