Whitepapers

Close gaps in culture-based testing before they delay product release
Friday, March 20, 2026
Culture-based contamination detection can extend timelines and may not detect every relevant organism fast enough for today’s cell therapy workflows. This application note reviews data from a qPCR-based MycoSEQ Plus workflow that delivered ... read more
Reduce contamination risk for short-shelf-life cell therapies with 5-hour sterility testing
Friday, March 20, 2026
For short-shelf-life cell therapies, waiting up to 14 days for sterility results can create real manufacturing risk and logistics challenges. This application note highlights a qPCR-based approach that detected the six USP <71> organisms in ... read more
Unlocking Primary Cell Transfection
Monday, March 16, 2026
ProteanFect™ TuffCell Transfection Kit is a novel, protein-based system designed to deliver nucleic acids efficiently and safely into difficult-to-transfect cell types. Using a coacervate-based mechanism derived from engineered mammalian ... read more
Overcoming AAV cargo limits: Dual AAV and triple vector strategies in gene therapy
Monday, February 23, 2026
AAV is a workhorse for in vivo gene delivery, but its ~5 kb cargo limit forces hard tradeoffs that can make or break a program. This white paper breaks down dual- and triple-vector designs used to push past that ceiling, how cells ... read more
Mix with confidence: LevMixer™ 10 L mixer delivers clean result
Wednesday, October 29, 2025
In our latest study, we evaluated particle generation in extreme conditions (mixing speed and temperature). The results? No increase of low visible and sub-visible particle levels, and well within United States Pharmacopeia specifications. read more
Optimize your mixing and filtration strategy
Wednesday, October 29, 2025
Elevate your process development with the LevMixer™ 10 L mixing system and Supor™ Prime filters. Discover improved mixing efficiency, sterility assurance, and scalability for cell culture media reconstitution – bench to GMP. read more
Monitoring to manufacturing: Cyto-Facto’s approach to safe and scalable cell and gene therapies
Tuesday, October 28, 2025
Discover how Cyto-Facto and Dr. Shin Kawamata and his team are overcoming the unique challenges of living therapies — such as maintaining sterility, standardization and traceability — by integrating QbD, automation, and continuous ... read more
Cell therapy system provides one-step isolation and activation with flexible active release to optimize T cell phenotype
Friday, November 01, 2024
Antibody-coated magnetic beads were crucial in the manufacturing process to achieve one-step cell isolation and activation, and enabled clinical-scale dose production within 2 to 3 weeks. Since then, the technology has become well ... read more
Navigating the complex testing strategies for viral vector-based gene therapies
Friday, November 01, 2024
Safely introducing transgenes into cells is one of the greatest challenges facing the field of gene therapy. Using viral vectors has become one of the most effective means to achieve this by taking advantage of a virus’s natural ability to ... read more
Upstream process development with a kLa criterion within the Bione single-use bioreactor
Friday, November 01, 2024
The FDA's Quality by Design (QbD) directive emphasizes the importance of comprehensive bioprocess characterization and understanding in future bioprocess development. It is recommended that process development incorporates a central ... read more

Close gaps in culture-based testing before they delay product release

Reduce contamination risk for short-shelf-life cell therapies with 5-hour sterility testing

Unlocking Primary Cell Transfection

Overcoming AAV cargo limits: Dual AAV and triple vector strategies in gene therapy

Mix with confidence: LevMixer™ 10 L mixer delivers clean result

Optimize your mixing and filtration strategy

Monitoring to manufacturing: Cyto-Facto’s approach to safe and scalable cell and gene therapies

Cell therapy system provides one-step isolation and activation with flexible active release to optimize T cell phenotype

Navigating the complex testing strategies for viral vector-based gene therapies

Upstream process development with a kLa criterion within the Bione single-use bioreactor

Subscribe to Magazine

Upcoming Events

BioTechX USA 2026

Meeting on the Mesa 2026

AAPS PharmSci 360 2026

Connect with Us