INSIGHTS ON ENTERPRISE SOLUTIONS

• Developing Custom GMP Lipids: A Patient-Driven Partnership

  Custom lipid programs depend on how process development and manufacturing teams collaborate, from first design through scale-up to GMP production for LNP-based therapies.

• Smarter Lead Selection And Faster Representative Material

  Accelerate biologics development with earlier high-titer material, reduced CMC risk, and faster lead selection using transposase-based vectors and stable bulk pools.

• Beyond Fed-Batch: Choosing The Right Path To Process Intensification

  Upstream intensification options, from concentrated fed-batch to N-stage perfusion, are weighed against organizational objectives, since no single technical strategy suits every framework.

• Why The CRO–Sponsor Relationship Is Becoming A Strategic Advantage

  Shared real-time data environments transform CRO-sponsor relationships, replacing communication silos with transparent, audit-ready clinical bioanalysis.

• Protective Shell For 2D Bags: Engineered For Mechanical Protection

  10/2/2026

  Protect frozen single-use bag assemblies from movement and handling stress with rigid secondary packaging, dedicated foam immobilization, and efficient plate-freezing heat transfer.

• CMC Considerations Around Unique Materials And Reagents

  10/2/2026

  In this segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” panelists advise on what to do when no GMP-grade equivalents exist for certain starting materials or reagents.

• The CDMO's Perspective: Audience Q&A With Thermo Fisher Scientific

  10/2/2026

  During this final segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” a representative and SME from the event sponsor enters the conversation. Mike Brewer, director and global principal consultant of regulatory and bioproduction at Thermo Fisher Scientific, joins the panel for a special Q&A session with the audience, discussing the challenges he’s witnessed sponsor companies face in the transition to clinical manufacturing.

• Transitioning A Process And Qualifying GMP Materials

  10/2/2026

  This opening segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” features panelists Tiffany Rau, Ph.D., an adjunct professor at University College Cork, co-founder of BioPharam Technical Consulting, and founder of Rau Consulting; Mary Rodley, an independent consultant at Medius Consulting; and Wei Lu, Ph.D., a senior staff engineer in downstream process development at Takeda. They share their thoughts on when preparation for clinical manufacturing should begin, especially in terms of qualifying compendial and GMP-grade materials.