02.13.25 -- Regulatory-CMC: A Core Practice For Successful CDMO Partnerships

Join this live webinar to learn about the journey of a biologic drug from pre-clinical to commercial release. SGS’s experts will share their extensive knowledge of testing required and ways to overcome challenges encountered throughout the various stages of the drug development process. Click here to learn more.

In a case study, chromatography process data converted into "images" equipped artificial intelligence to help manage dynamic binding capacity degradation.

By leveraging transposase-mediated tech together with transposon design to achieve semi-targeted integration, drug developers can achieve more efficient biotherapeutic protein production.

Understanding the key elements in the handover stage of a technology transfer is critical to your success. This is an overview of the Handover Stage of PDA TR-65.

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.

Learn more about the cutting-edge technologies driving the shift to microbial expression and how the right outsourcing partner can help you leverage the benefits of these innovative therapeutics.

Utilizing incurred sample reanalysis (ISR) in your quality control can help mitigate risks, establish regulatory compliance, maintain data integrity, and instill confidence in pharmacokinetic modeling.

In this interview, KBI Biopharma process development experts discuss how advanced cell line development and transposase technology streamline the path to toxicology and first-in-human studies.

Peter Skals, Head of Global Sustainability, shares how the company is integrating its climate and ESG strategy while simultaneously expanding its CDMO network and reducing its CO₂ footprint.

Despite the growing body of research and scientific knowledge, perhaps the biggest challenge with LNP formulation is the journey into the unknown.

As the field of biologics increases its focus on identifying new diseases to target and novel constructs to treat them, innovative administration devices are once again in the spotlight.

Join Outsourced Pharma Live for an in-depth examination on how the BIOSECURE Act is impacting risk management, compliance, and the future of global outsourcing in drug development and manufacturing. Our supply-chain experts will provide actionable insights to ensure your outsourcing strategies align with the greater legal, regulatory and geopolitical environment. Secure your free registration today!

Our biologics development services support global clients in all clinical phases and global regulatory arenas and include both process and formulation development.

Unlock the potential of your antibody-drug conjugate development by partnering with our experts in bioconjugation to ensure the efficacy, safety, and scalability of your innovative therapies.

Due to the complexity of the drug structure, it is necessary to provide accurate and stable test results through suitable analytical methods.

Director of Technical Transfer JoAnne Jacobs details the roots behind our team and our purpose: to deliver best-in-class CDMO services to fulfill the increasing need for injectable drug product supply.

Corvus, a small biotech developing precision medicines was seeking to develop a monoclonal antibody called CPI06, now known as Mupadolimab. Find out what happened next.