Articles & Research from Venn Life Sciences

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

CMC regulatory team capabilities

For 20+ years, members of the CMC regulatory team supported several (bio)pharmaceutical companies to ensure manufacture of safe, effective, and high-quality drug products for patients globally

Strategies for Non-clinical safety assessment of vaccines

Setting the scene Over the past century, vaccines have made a large impact on public health, as recently demonstrated by the treatment of the worldwide Covid-pandemic. Since, in general, vaccines are administered to healthy individuals, including infants and children, it is important to demonstrate the...

The Drug development plan – Your roadmap to success

Each journey begins at a starting point, and we believe that few journeys are as exciting as developing a drug. In order to succeed and reach your destination, you need a solid roadmap, the drug development plan (DDP), this is the outline of your drug...

Safe starting dose in a First-in-Human trial: When & How to Prepare?

The first‐in‐human (FIH) clinical trial is an important milestone for each development program. For small (bio)pharma companies the FIH trial requires a significant investment, and every sponsor wants to make sure that all is well set for starting the trial. It is indisputable that successful...

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