Newsletter | August 27, 2024

08.27.24 -- Clinical Trials In China Reboot BIOSECURE Act

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FEATURED EDITORIAL

Clinical Trials In China Reboot BIOSECURE Act

Clinical trials are not my beat, but the BIOSECURE Act targeting CDMOs sure is. Now the congressional committee involved with putting that legislation together has found something of perhaps more substance, and better substantiated, to add to the impetus of the Act: clinical trials in China.

Select Your CDMO Based On How You Operate

“We tell them up front we will be hands on. That's a good way to pick the right partners. In other words, we select and view our CDMOs based on the way we operate," explains BlueSphere Bio CEO Keir Loiacono. With a background as an attorney, it's an interesting outsourcing operations indeed.

How CSL Behring Worked With EMA/FDA To Develop Hemgenix Potency Assays

Gene therapy products are complicated, and it can be hard to know at which step to measure potency. Here's how CSL Behring did it for Hemgenix.

INDUSTRY INSIGHTS

Accelerated Development: Gene Therapy Vs. Small Molecule

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

Exploring The Cost Considerations Of Immune Cell Therapies

Immune cell therapies have incredible potential for cancer treatment, and making them more cost effective is a critical consideration for improving patient access and outcomes.

Potent Immune Response With Vernal's LNP-mRNAs

As mRNA medicine continues to evolve, understand how trusted manufacturing partners will continue to play a pivotal role in translating innovative concepts into clinical reality.

Unlocking Potential: A Deep Dive Into AAV Development And Manufacturing

When it comes to furthering AAV's potential in the biopharma pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.

Scalable Suspension LVV Production Platforms

Review a scalable suspension-based Lenti production platform using a proprietary HEK293T clonal cell line and improvement steps to generate commercially viable therapies from concept to patient.

Leveraging The Right RNA Polymerase Enhance Capping Efficiency

By utilizing an engineered co-transcriptional capping RNA Polymerase, researchers can reduce dsRNA byproducts and enhance the functionality of mRNA therapeutics.

Reduce The Environmental Footprint Of Oligonucleotides

Industry experts answer attendee questions from a recent webinar about sustainability concerns surrounding oligonucleotide manufacturing.

The Importance Of Advanced Solutions For CGT Material Management

Innovative supply chain solutions can help companies mitigate risk to their overall supply chain while saving valuable capital for the research of their lifesaving therapies.

Navigating Challenges In Progressing Breakthrough RNA Therapeutics

RNA therapeutics hold promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and timelines can help reduce costs.

SOLUTIONS

Gene Editing

We have a powerful suite of proprietary gene editing technologies to accelerate the development of life-changing and curative therapies for patients.

Allogeneic And Autologous Cell Therapy CDMO Services

As a CDMO Partner for Life, our goal is to advance your cell therapies from lab to commercial scale, leveraging our CGT expertise and global cGMP network.

UpTempo AAV Platform Process

The UpTempo AAV platform process is a scalable, cGMP-ready process for viral vector manufacturing that can reduce the current development timeline for drug product in half.

Pfizer CentreOne Capacity Update May 2024: Cell & Gene Therapy

Review Pfizer CentreOne’s overall gene & cell therapy capabilities, with a focus on their ability to help meet your complex viral vector needs.

Plasmid DNA

Our microbial team is dedicated to providing solutions in pDNA manufacturing, including long terminal repeat (LTR)-containing plasmids, for gene and cell therapy developers.

Cryopreservation Centers Of Excellence

Learn how our cryopreservation services are enabling hospital, biotech, and pharma clients to safely preserve and store valuable cellular products, tissues, and biomaterials.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

Connect With Outsourced Pharma: