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Addressing Downstream Challenges with Complex Injectables



WEBINAR

As per the US Food and Drug Administration (FDA), complex parenteral products are those formulations which contain either complex ingredients or API, complex formulation, i.e. delivery carrier, complex route of administration, complex dosage form, or complex drug device combination. The manufacturing of the complex injectable products is different and a great level of observation of quality and care is required during their manufacturing, packaging, distribution, and storage. Complex injectables have gained increasing attention due to their widespread use in life-threatening and chronic diseases treatments. The category includes diabetes, oncology, and hormonal therapy.

In this webinar, you will learn:

  • Why downstream processing (specifically sterile filtration) is critical and complicated
  • About the sterile filtration of liposomes, nanoparticles, and viscous formulations
  • About filter validation aspects and where our approach is different

Speaker

Partha Banerjee

Partha Banerjee

Merck

Senior Technology Consultant

Partha is a senior technology consultant, currently covering India subcontinents in the fields of sterile filtration and filter validation services for the last 13 years. His technical competencies include downstream process development for biopharmaceuticals (esp. small molecules/peptides) and in-process troubleshooting (shop floor issues and regulatory queries). He is also responsible for the design and process development of complex parental formulations.