INSIGHTS ON DRUG DEVELOPMENT

• Telltale Signs You’re With The Wrong CDMO

  Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

• How Outsourcing Buffer Prep Enables A SARS-CoV-2 Vaccine

  As numerous therapeutic drug and vaccine candidates make their way through human clinical trials, companies are already planning for how to manufacture any successful molecule on a global scale.

• End-To-End Thinking During Drug Product Development

  In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.

• Pluripotent Stem Cell Expansion And Scale-Up

  Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.

• Automated Bag Thawing System For CAR-T Cell Therapy Manufacturing

  1/11/2022

  The performance of the VIA Thaw CB1000 is compared to thawing in a water bath. The VIA Thaw™ dry thawing system shows comparable performance to a water bath with less handling.

• The Role Of CDMOs In Cell And Gene Therapy Process Development

  8/5/2020

  This article highlights areas where CDMOs can help companies get started in CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.

• Knowledge Is Power: Overcoming Bioprocess Development Challenges

  11/3/2021

  Decisions regarding bioprocess cell line, media, scale-up, and regulatory approval can have direct effects on speed-to-market and costs. Thankfully, many process development challenges can be mitigated or even avoided. Read how to address some of the most common opportunities to achieve a more efficient journey to market.

• Mutual Understanding: The Art Of Successful Technology Transfer

  5/4/2021

  Each tech transfer operation is different. However, there are common steps that can be used to give the process the best chance of success.

• Formulation Research Strategy For Discovery- Stage New Drug Candidates

  1/24/2022

  Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.