Newsletter | November 16, 2023

11.16.23 -- Gamida Cell On Improving NK Cell Therapies

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Improving Resilience of Post-Pandemic Biopharma Supply Chains

Improving supply chain resilience is critical for Biopharma. One lesson learned from the pandemic is the need for new models and approaches to managing supply chains. Download our white paper to learn more about how a value chain model mitigates risk, the four critical ingredients to supply chain resilience, and why preparations based on "the last war" aren't enough.

FEATURED EDITORIAL

Proposed Best Practices For Cell & Gene Therapy Aseptic Process Simulation

Aseptic process simulation (APS) plays a critical role in demonstrating that the processes, equipment, and materials involved in sterile manufacturing work in synergy to maintain sterility. Applying existing APS guidelines to cell and gene therapies/ATMPs can be challenging, so BioPhorum proposes a best practice approach in alignment with regulatory guidance.

Gamida Cell On Improving Natural Killer Cell Therapies

Gamida Cell CEO and CSO discuss the company's nicotinamide (NAM) technology and its potential to improve natural killer (NK) cell therapy products.

INDUSTRY INSIGHTS

Contamination Control Considerations For Cell And Gene Therapy Facilities

Gain a thorough understanding of active HEPA purging pass-throughs along with the numerous benefits associated with their use in cell and gene therapy facilities for material control.

Overcoming Commissioning Challenges To Achieve Operational Readiness

As the data center market continues to grow exponentially, third-party testing and commissioning have become vital to achieving operational readiness on time and within budget.

Improve Your Processes With Alternative Buffer Management Strategies

Understanding the alternative buffer management strategies available can help ensure you have the tools and resources necessary to remain competitive in today’s growing bioprocessing industry.

How To Best Optimize CD4 T Cells Expansion

Learn how stirred-tank bioreactors can be used to efficiently expand T cells from different donors.

Leverage Automated Workflows To Enable Complex Organoid Assays

Learn about automated methods that utilize an integrated workcell, providing automated cell plating, culture monitoring, media exchange, and high-content imaging.

Recommendations For Successful IND Approval Of RNA-LNP Drugs

The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

Immunohistochemistry (IHC) Handbook

Learn more about immunocytochemistry, immunohistochemistry workflow, visual workflow, troubleshooting, and basic buffer and reagent recipes.

Disrupting The Cell And Gene Therapy Manufacturing Industry

Learn how the off-site manufacturing of modular/podular cleanrooms is affecting therapeutics and the cell & gene industry.

Streamlining Viral Vector Development And Gene Therapy Manufacturing

Explore solutions for gene therapy production from experts, as they highlight the key features of a GMP manufacturing facility, including its technologies and infrastructure, through a virtual tour.

Cryopreservation's Impact On Cell Therapy Consistency, Quality

Explore the underpinning mechanisms driving freeze/thaw applications and their implications across varied drug product containment configurations and volumes.

Building The Complete Solution For Viral Vector Production

AAV is becoming the go-to biological delivery method for gene therapy breakthroughs. Learn how to scale and accelerate your viral vector production from research to commercialization.

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Webinar: Upstream To Downstream: A Comprehensive Approach To AAV Production

Paula Decaria and Chiu Lau-Barre of Thermo Fisher Scientific will share strategies to meet the rapid pace of the industry. Gain insights on the challenges and considerations involved in scaling up AAV manufacturing processes, facilitating AAV production with high titers using single-use bioreactors at 50 L to 500 L to 1,000 L scales and techniques for enhancing recovery and purity in downstream processing.

SOLUTIONS

INDe sgRNA Manufacturing

Process Development Services

Chromatography Resins For Efficient Purification Of Oligonucleotides

Introducing On-Demand Cell/Cell Line Mimics

Discover A Platform For Antibodies With Increased ADCC Activity

Cationic Lipids For LNP Formulation: LipidBrick IM21.7c

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As additional mRNA-based cancer immunotherapies vaccines enter clinical development, operational and supply chain challenges must be addressed to reduce turnaround times and COGS. Join Cell & Gene Live on December 5 for a breakdown of ways to address uncoordinated and inefficient processes to promote greater stability and immunogenicity. This digital event is free to attend thanks to the support of Thermo Fisher Scientific. Register Now

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