Articles & Research from Venn Life Sciences

Scale-up and scale-down approaches in biologics

Appropriate scale-up/down is key for further larger production. Important is to focus to the right parameters that can help us to set the design for all experiments at lab scale.The common approach within the up-stream processing (USP) part in biologics is to increase the scale...

CMC regulatory team capabilities with Medical Devices

The CMC regulatory team has 20+ years’ experience supporting several pharma (small and large molecules) and medical device companies to ensure the continual manufacture and supply of high quality products to patients in licenced global markets.

Medical Writing

Small dedicated team of Senior Medical Writers and Clinical Trial Assistant with total team experience in clinical and regulatory writing of more than 75 years.

Clinical Trial Management

Venn clinical trial management group has the expertise to set-up, coordinate and deliver clinical trials including vendor selection, investigational product logistics, data management, safety analyses, reporting, and clinical monitoring. We have experience with chemical entities, vaccines, and generic compounds.

From Bench to Clinic: Hurdles in Gene Therapy Development

CMC evolution during gene therapy development Gene therapy offers significant potential to treat diseases with high unmet medical need. However, the unique nature of these therapies poses challenges in product development, namely: safety concerns, efficacy issues, or obstacles related to Chemistry, Manufacturing and Controls (CMC)....

CMC team capabilities New Chemical Entities

For 20+ years, members of the CMC (Chemistry Manufacturing and Control) team have supported and are supporting numerous pharmaceutical companies to ensure the timely development and manufacture of high-quality drug substances and drug products for non-clinical- and clinical studies.

Non Clinical Development

Non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic/toxicokinetic (PK/TK) characteristics of drug candidates. If performed well, it can identify key ‘knock-out’ criteria early, maximizing the chances of success in subsequent clinical development.

CMC team capabilities for biologics

For 20+ years, members of the CMC (Chemistry, Manufacturing and Controls) team supported numerous (bio)pharmaceutical andbiotechnological companies to ensure the development and manufacture of high-quality drug substances and drug products

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