Cell and Gene Manufacturing and Logistics
-
Smart Scaling For Cell And Gene Therapies
2/5/2026
To meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.
-
Sterile Filtration Of Cell Debris
2/5/2026
AccuStrain™ 40μm & 150μm Filters are designed and packaged for bioprocessing applications, providing filtration of cell aggregates and extraneous particulate removal in cell separation, media preparation, and final fill workflows.
-
Why Clinical Supply Risk Starts With Demand Signals
2/5/2026
Clinical supply risk often begins long before manufacturing or distribution. Flawed demand signals and enrollment forecasts can quietly create shortages, delays, and costly material waste.
-
How To Choose The Right Isolator For Cell Therapy
2/4/2026
Closed isolator systems provide Grade A aseptic environments necessary for cGMP cell therapy scaling. By integrating essential equipment and automation, these systems ensure rigorous quality control.
-
Maintaining Sterility Through Precise Component Design And Manufacture
2/4/2026
Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.
-
Derisk Multimodal CGT Manufacturing With These Key CDMO Capabilities
2/4/2026
For CGT sponsors developing multiple modalities, choosing one CDMO partner that can manufacture each of their drugs enables speed and consistency. However, developers must be rigorous in their assessment of multimodal partners, evaluating contamination control, technical prowess, quality infrastructure, and regulatory expertise.
-
Sourcing, Analyzing, And Ensuring Quality In CGT Raw Materials
2/4/2026
Biopharmaceutical sponsors should utilize phase-appropriate strategies to mitigate risks like material variability and regulatory scrutiny in cell and gene therapy development. These proactive measures ensure quality and supply chain security, stabilizing delivery of these complex treatments despite significant cost and consistency challenges.
-
Flexible Cell Culture Media For High Titer Production Of AAV In HEK 293
2/4/2026
To maximize the results of viral titer and full capsids, it's necessary to undertake systematic process development and optimization of AAV production. The choice of cell culture medium is foundational.
-
AccuStrain™ Filters: 40μm And 150μm For Bioprocessing Applications
2/4/2026
Discover how these sterile filters remove particulates with high efficiency while supporting flexible setup, low hold‑up volume, and cleanroom‑compatible packaging to help maintain process integrity.
-
Compressing Tech Transfer Timelines Through Digital CMC Standardization
2/2/2026
Digital CMC platforms address tech transfer inefficiencies by unifying process knowledge, reducing compliance risk, and significantly compressing CDMO onboarding timelines.