Newsletter | March 28, 2024

03.28.24 -- What Does It Take To Make Higher Quality AAV?


Setting the Standard in Reproducible Performance

Start with a process that delivers high performance and ensure your results can be consistently reproduced. Accelerate your cell and gene therapy development with high-throughput technologies that promote process efficiency, optimized critical raw materials that improve yield, and intuitive data analytics that inform decision-making. Whether you’re in early drug development or approaching large-scale manufacturing, you can rely on our productivity-driven solutions to help you set the standard in reproducible performance. Learn more.


What Does It Take To Make Higher Quality AAV?

In this episode of Cell & Gene Live, experts examine the current state of AAV quality control and improvement, as well as which advancements the industry could be on the brink of realizing.

What's New For 2024: A Look Inside The Office Of Therapeutic Products

What is the Office of Therapeutic Products, where did it originate, and what's on its regulatory agenda for 2024? Dr. Nicole Verdun provides information about the new super office, which is the result of a reorganization of CBER’s Office of Tissues and Advanced Therapies.


Quintessential Role Of Apheresis In Gene-Modified T Cell Therapy

Learn more about process standardization and comprehensive quality management programs as it relates to leukapheresis and cell therapy manufacturers.

Remote Regulatory Assessments Q&A: Here To Stay

Explore what remote regulatory assessments (RRAs) are and how updated guidance on these examinations could help clarify the consequences of non-compliance.

Breaking Down Barriers In Cell Therapy Manufacturing

A byproduct of several cell therapy groups attempting to reduce process complexity to make them safer and more cost-efficient is that there's a lack of standardization across the production sector.

Flexible, Global Delivery For Alzheimer’s Patients

Uncover how MRN was able to take charge of overseeing clinical trial nurses and participants and work with Washington University to deliver clinical services to over 100 participants worldwide.

Guidance For Pass-Throughs In cGMP Cell And Gene Therapy Facilities

How do active purging pass-throughs offer a higher level of material control for cell and gene therapy facilities? Get the answer here.

Strategic Clinical Consulting Success Stories

Access real-world examples of how the combination of strategic consulting, regulatory insights, and technical expertise can impact the development and approval process.

Disrupting The CGT Manufacturing Industry

Dennis Powers, VP of Sales Engineering and Business Development, discusses how the off-site manufacturing of modular/podular cleanrooms is affecting therapeutics and industry.


Modernizing TMF Culture To Better Support Today's Clinical Trials

TMF can represent two very different concepts: for some, it's "Trial Master File," while for others, it jokingly stands for "Too Much Fun!" This duality highlights diverse attitudes toward the essential task of preparing and managing the content within the TMF. When structured as a more engaging and less overwhelming task, the TMF can be more beneficial for all who must collaborate to complete it.


Process Development Services

Cleanroom Partnership Showcase: Avid Bioservices

Orphan And Rare Disease CRO Services


Stem cells are the backbone of many allogeneic therapies and where they come from affects development and supply chain logistics, particularly cryopreservation. What temperatures are ideal to maintain product potency? How do you build a reliable cold chain? How do you work with existing infrastructure to allow for an “off-the-shelf” therapy? Don’t miss the next Cell & Gene Live digital event! Registration is free thanks to the support of Charter Medical and Bio-Techne.

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