Establishing PK biocomparability continues to be an important challenge for the pharmaceutical and biotech industry. Overcoming the challenges within biologic therapeutics have led to many innovative bioanalytical approaches. One such approach was using a monoclonal antibody called siltuximab.

Today, we wanted to share a presentation deck titled “An Innovative Approach for Effective Clinical Evaluation of PK Biocomparability” from Chao Han at J & J. Mr Han delivered this talk at one of our past Controlled & Modified Drug Summits. This presentation will give a brief overview of regulatory requirements, current practice & challenges for biologics and present data on an innovative approach using siltuximab, including presenting the results of a PoC animal study

Scroll through the presentation below……

2024 Controlled & Modified Drug Release Summit

(May 14-15, 2024, Princeton, NJ)

 

Interested to improve the performance of your drug products? Learn 2 years of new drug product development approaches at the 2024 Summit this coming May both in-person & virtual.

Join 160+ leading drug delivery, formulation and development experts and hear 30+ expert sessions. Gain over 2 years worth of new drug product development strategies, formulation approaches, delivery technologies and regulatory updates while decreasing drug product time-to-market in just 2 short days (all available on-demand)!

Save up-to 45% on attendance before Friday 29th September, 2023. Likewise, have a platform technology you would like to explore showcasing to the wider audience this May? Reach out below to find out remaining opportunities.

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