Newsletter | June 19, 2025

06.19.25 -- Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements

FOCUS ON MANUFACTURING

Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements

This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

Vial Adapter Considerations For Cell And Gene Therapy Applications

Review features that need to be considered to choose a vial adapter for cell and gene therapy drug products and a case study where vial adapter transfer devices have been used to extract lentiviruses.

Maintain Sterility And Ease In CGT Development, Including Cryopreservation

Sterile connectors streamline cell and gene therapy processes while maintaining sterility. By withstanding extreme temperatures and cryoprotectants, they can ensure product viability during cryopreservation.

CHOp Your Protein Production Timelines

How can you leverage flow electroporation technology to drive your biologics development forward and deliver gram-scale transient protein production within two weeks?

Reducing CAR-T Manufacturing Costs And Duration

Addressing critical hurdles in CAR-T cell production, this research demonstrates methods to enhance efficiency and reduce expenses for broader patient benefit.

Revolutionizing Cell Therapy Manufacturing With AI

Discover how AI can optimize processes, improve efficiency, and enhance the understanding of cellular processes, ultimately leading to more effective and personalized patient treatments.

Selecting The Right Single-Use Materials In Biopharmaceutical Manufacturing

Manufacturing operations are getting a boost thanks to single-use technologies, but how do biopharmaceutical manufacturers choose the right materials for constructing their single-use solutions?

Using Robotics In The ATMP Space

With regulatory requirements and GMP recommendations trending towards less human interaction and more robotic automation, robotics is the way of the future for the ATMP industry.

Viral Vectors: Are We There Yet?

What must we do as an industry to continue the momentum of cell and gene therapies and ensure these revolutionary treatments become a reality for patients who need them?

3 Things To Consider For Capacity Expansion

In this panel discussion, you’ll learn from experienced colleagues who share their approaches to capacity expansion and offer tips for your success.

Responding To Fill-Finish And Automation Scale-Up Challenges

Behind every life-saving cell therapy is a complex manufacturing journey. Examine the critical role of automation in overcoming production challenges and ensuring quality.

Three Key Considerations For Optimizing Process Development

When it comes to process development, timing, technology, and partners all merit careful consideration. Explore expert insights into these three crucial factors.

Tackling Allogeneic Immunotherapy's Scale-Up Bottleneck

New bioreactor technology provides an optimal environment for shear-sensitive cells, addressing key scale-up challenges for allogeneic therapies from research to commercial production.

Mastering The Complexity Of CGT Process Development

Successfully bring your CGT products to market by joining industry experts as they discuss challenges in CGT process development.

MANUFACTURING SOLUTIONS

Organ On A Chip: Advancing New Approach Methodologies - Battelle

CRISPR From Research To Therapy - Lonza

Ultra-Sensitive, Precise Structural Measurements Of Your Biomolecules - RedShiftBio

At-Line Analysis For Cell Culture Media - Repligen – PAT

Sterility Testing For Cell Therapy Bioproduction Samples - Thermo Fisher Scientific

Filter Guide For Exosome Research - Cytiva

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