Defining critical parameters and processing large quantities of data can be a challenge.
Challenges remain for virus removal and validation.
New investments, expansions, and company rebranding are discussed at CPhI.
Adding light scattering to size-exclusion chromatography (SEC) can maximize the benefits of SEC.
Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.
Careful selection of downstream processing conditions is a must.
Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.
Going beyond pharmacopeial requirements is essential for the quality and safety of raw materials.
Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization.