04.22.24 -- Considerations For Robust Implementation Of The Multi-Attribute Method

Complex next generation biological molecules are becoming increasingly prevalent in today’s biopharmaceutical manufacturing landscape. Through case studies, this webinar will highlight innovative analytical strategies designed to address common challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs and diverse post-translational modifications. Click here to learn more.

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

Continuous manufacturing is more efficient than fed-batch manufacturing at the same production scale. Explore key considerations when choosing continuous bioprocessing and a continuous cell culture manufacturing platform.

From the digital infrastructure needed to enable a collaborative approach, to the quality systems and analytical methods, effective tech transfer relies on the careful consideration of a variety of factors.

The key to navigating the biologic development journey lies in CMC. By analyzing and characterizing the drug's properties, CMC teams ensure a smooth path from bench to patient care.

Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

Industry experts answer attendee questions from a recent webinar about methods for expressing and manufacturing complex biologic drugs.

Tour a facility that includes characterization testing, bioassays, and QC located at the same site as GMP manufacturing, helping you forge a faster path to clinic and product commercialization.

Learn how robust in-house analytical services and protein characterization are crucial for successful development and manufacturing programs.

With a strong network of sites, Resilience provides innovative solutions and services for established and emerging therapies. Discover how we can support your development and manufacturing programs.