New eBook – Get ahead of GMP challenges with smarter raw material strategies

As cell and gene therapies advance toward clinical and commercial manufacturing, raw materials are increasingly shaping GMP success. Consistency, traceability, and regulatory alignment depend not only on sourcing the right materials, but on how they are qualified, managed, and used throughout the process.

To support researchers facing these challenges, we created new eBook, in collaboration with RegMedNet, on raw materials and supply chain management in GMP cell and gene therapies.

In this eBook, we feature an expert interview with insights on raw materials and supply chain management in GMP‑grade manufacturing for regenerative medicines. With a focus on cell and gene therapies, it explores the pivotal role these factors play in supporting successful manufacturing outcomes.

What you’ll learn:

• How early raw material decisions affect GMP transitions and scalability
• Why GMP‑grade media design and RUO analogues help preserve biological performance
• What regulators expect regarding raw material qualification and pharmacopoeial alignment
• How storage, handling, and internal supply chain practices help protect material quality

This eBook also brings together opinion piece, practical workflows, and peer‑reviewed content covering key areas of GMP manufacturing, including:

• Cell and gene therapy media and reagents:
  A practical breakdown of serum‑free, chemically defined, xeno‑free, and animal component‑free media—and how each impacts safety, reproducibility, and regulatory compliance.
• GMP‑compliant cell expansion workflows:
  An application note detailing mesenchymal stem cell cultivation in single‑use stirred tank bioreactors, highlighting the role of GMP‑grade media in scalable manufacturing.
• Pilot Evaluation Batch (PEB) program:
  Gain early insight into our service and de‑risk GMP scale‑up with pilot‑scale media as a strategic pre‑validation step.

This eBook was made in collaboration with RegMedNet