Newsletter | December 10, 2024

12.10.24 -- I Outsource, Reluctantly

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Put Your AAV On The Fast-Track To The Clinic

Advancements in molecular biology and viral therapy over the last 30 years have enabled rapid progression in the gene therapy space. Viral vectors, most notably lentiviruses, adenoviruses, and adeno-associated viruses (AAVs), are regularly used as gene delivery vehicles in gene and cell therapies. To meet the increasing demand for AAV gene therapies, developers and manufacturers must successfully navigate the challenges of AAV production. Learn more now.

FEATURED EDITORIAL

I Outsource, Reluctantly

“I’ve worked with CROs and CDMOs since 2000,” says an outwardly jovial Jin-an Jiao, VP, Process and Analytical Development, Synthekine, a developer of CAR T therapies and biologics. His apparent mirth, though, masks a complication: Generally speaking, Jiao is a reluctant outsourcer. Here's how he handles that.

Emerging Partnership Trends In Oligo-Based Medicines

The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.

INDUSTRY INSIGHTS

The Role Of Platform Processes In Cell Therapy

Learn how the streamlined processes and reduced complexity enabled by a platform approach can lead to scalable manufacturing, rapid delivery, and expanded patient access for cell therapies.

Tech Transfer: 8 Typical Stumbling Blocks To Avoid

Optimize your biopharmaceutical technology transfer by prioritizing clear communication, thorough training, and strategic planning to ensure success.

Maximize Starting Material Consistency

By implementing an efficient characterization strategy, researchers can enhance the consistency of allogeneic cell therapy starting material, ultimately leading to improved clinical outcomes.

Overcoming Challenges: Optimize And De-Risk Your mRNA Product Manufacture

mRNA therapy and vaccine manufacturing can become complex and challenging when working with multiple CMOs. Partnering with an end-to-end CMO is key to overcoming these hurdles.

Realizing A New Approach To Allogeneic Cell Therapy Process Development

Increased investment in allogeneic therapies and process-level advancements to achieve commercial scale are paving the way for streamlined, standardized cell therapy development and manufacturing.

RNA Nanoparticle: Formulation, Process, And Characterization

As the field grows, understanding how to formulate RNA nanoparticles effectively is essential for advancing therapeutic innovations.

Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics

What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?

Methods for mRNA Poly(A) Sizing

This study used Oxford Nanopore Technologies' Direct RNA Sequencing Kit and obtained successful sizing of poly(A) tail regions. The results are presented in a histogram and table format.

cGMP-Ready HEK293 Cell Line For AAV, Lentiviral, And Adenoviral Production

See how this advanced SKPT-HEK293 4G9 was able to provide a robust, CGMP-ready solution for efficient viral vector production, supporting a range of AAV serotypes and CAR-T Lenti-viral vectors.

Tackling Cell & Gene Therapy Manufacturing Challenges

Allogeneic therapies are gaining popularity due to diversity, scalability, and affordability. A partner with innovative solutions can help streamline the path from discovery to commercialization.

Accelerated Adventitious Virus Testing In Viral Vector Vaccines

Implementing NGS technology for adventitious virus testing in viral vector vaccine development and manufacturing is crucial for ensuring safety. Gain insights for an optimized sequencing method.

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.

Untangling The Regulatory Maze Of The ATMP Supply Chain

For ATMP manufacturers seeking to expand operations across the EMEA region, understanding global trade and supply chain regulations is crucial.

Engineered Plasmids, Optimized HEK293 Cell Line Improves AAV Productivity

Low AAV productivity and lack of platform processes continue to drive AAV production costs up. Explore a robust and scalable suspension manufacturing platform for AAV production.

Reducing Risk For Commercial Manufacturing Of Cell And Gene Therapies

For any biotherapeutic in development today, a critical element in achieving commercialization is reducing manufacturing risk.

How We Deliver The Science, Partnership And Technical Solutions You Need

Uncover how our collaborative approach positions us as an extended workbench for our partners, enabling faster, more effective solutions for patients.

SOLUTIONS

Kit Building: High Quality Kit Packing And Distribution

Discover better logistics support for the pharmaceutical, biotechnology, and medical device industries with high-quality kit packing and distribution through in-house kit-building facilities. 

Virotherapy Manufacturing

We navigate the rapidly evolving field of virotherapy to support the development and manufacturing of your gene therapies, viral vector vaccines, and oncolytic viruses (OVs).

CDMO Services: Customized mRNA-LNP Solutions

Take advantage of a highly connected CDMO network that has the capabilities to ensure quality, speed, scalability, and flexibility. Learn more about the services available.

Capacity Update October 2024: ADC

Leverage our flexible solutions and access to proprietary CHO-K1 cell lines in our state-of-the-art cGMP suites equipped with both single-use and traditional stainless steel bioreactors.

Codex HiCap RNA Polymerase

Codex HiCap RNA Polymerase delivers enhanced safety, cost-effectiveness, and performance, empowering researchers to unlock the full potential of mRNA therapeutics.

Capacity Update October 2024: Cell & Gene Therapy

Katie Jorgensen introduces ElevateBio BaseCamp's path to commercial readiness in cell therapy, highlighting key strategies for scaling from clinical to commercial manufacturing.

Technologies That Smartly Scale iPSC To Benefit Human Health

Learn how leveraging a GMP-like environment even in early R&D stages is crucial for setting your cell therapy up for success as you advance toward IND and NDA approvals.

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.

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