INSIGHTS ON CELL & GENE MANUFACTURING AND LOGISTICS

• LVV Manufacturing: Old But Gold Gene Therapy Viruses?

  Discover how plasmid design, transfection protocols, and controlled freezing methods combine to address critical manufacturing challenges in lentiviral vector production for gene therapy applications.

• UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk

  Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

• Compliance, Costs, And Site Readiness In CAR-T Clinical Trials

  Navigate CAR-T trial complexity: uncover key compliance, budgeting, and site readiness strategies to ensure safe, efficient, and successful patient care.

• All The Ways Global Biopharma Still Grapples With Annex 1

  Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

• 3PBIOVIAN Animal Health

  Partner supporting advanced veterinary biologics with flexible capacity, technical depth, and end‑to‑end capabilities spanning vaccines, recombinant proteins, antibodies, and next‑generation therapies.

• Managing Operational Challenges In CAR-T Clinical Trial Logistics

  Coordinating CAR-T trials means managing tight timelines, cryogenic handling, staffing gaps, and chain-of-identity risks where even small missteps can delay care.

• Why Manufacturing Drives FDA CRLs In Cell Therapy

  Manufacturing and quality gaps drive most FDA Complete Response Letters in cell therapy, often stemming from early‑stage decisions and unresolved CMC issues that become major late‑stage approval risks.

• 10 Questions To Ask When Choosing A Cell Therapy CDMO

  A strategic framework outlines ten critical questions to evaluate a manufacturing partner’s reliability, expertise, performance, and operational rigor to ensure successful, scalable cell‑therapy development.

• Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables

  A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

• Pipetting Robot For Full Workflow Automation

  Frees you from routine pipetting and provides excellent results