Newsletter | July 23, 2020

07.23.20 -- How To Maintain Product Integrity In Biologic And Biosimilar Clinical Studies

 
Innovative Strategies To Maintain Product Integrity In Biologic And Biosimilar Clinical Studies
 

Delays encountered during clinical studies can have a serious impact on competitive advantage, speed-to-market, and the availability of lower-cost alternatives for patients. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies, which will almost certainly require cold chain handling.

Establishing Parameters For Success
 

Applying clinical supply management expertise overcomes inventory challenges for a complex, global study. A CRO customer and clinical sponsor both lacked an unblinded supply management role to oversee interactive response technologies platform (IRT) supply strategies and monitor clinical supply inventory levels for a complex global study.

Expediting Path To Clinic With OptiForm Total Supply
 

MGB Biopharma, a biotech company based in Scotland, UK, was developing a new class of anti-infective medicine based on minor groove binder compounds. Learn how integrated formulation development, clinical trial material manufacturing, and supply and distribution services ensured successful delivery of the kits to MGB's patients.

Solutions