Newsletter | July 2, 2024

07.02.24 -- Breaking: BIOSECURE Act Out. Long Live Wuxi Apptec?

FEATURED EDITORIAL

Breaking: BIOSECURE Act Out. Long Live Wuxi Apptec?

The U.S. House Rules Committee did not include the BIOSECURE Act in the final list of amendments for the National Defense Authorization Act (NDAA). Chief Editor Louis Garguilo has been outspoken in defending WuXi Apptec’s right to due process. Readers have responded in spades. Here's the latest.

New Guide Tackles Best Practices For Making Allogeneic Cell Therapies

The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into some of the bigger themes in its recent guide.

Don't Blame The Molecule; You May Be The Problem

Ali Pashazadeh has been a healthcare investment banker for 20 years, surgeon for 30, and biotech CEO. Today he leads Treehill Partners. “I can explain our logic in two minutes,” he says of his approach to developing drugs, and targeting diseases.

INDUSTRY INSIGHTS

6 Key Questions When Selecting Your Cell Banking Manufacturing Partner

Evaluating a cell banking partner's experience, testing capabilities, and approach to material management can help guarantee the quality and consistency of your cells.

Enhance Autologous Cell Therapy Trials With Collaborative Protocol Design

Uncover how autologous cell therapy clinical trial protocol designs can greatly benefit from the inclusion of multifunctional, multi-departmental stakeholders’ input and feedback.

Optimization-By-Design - A Critical Factor In Viral Vector Scale Up

Learn how leveraging the expertise and capabilities of an experienced partner is a key factor in optimizing AAV processes using DoE, thereby reducing variability and risk.

Producing High-Quality, Therapeutically Relevant NK Cells

This platform for allogeneic NK cells offers a scalable solution for the production of potent and viable NK cells as well as enhanced expansion of NK cells >12,000 fold.

Safe And Compliant Shipping Of Viral Vectors In Gene Therapy

Learn about customized shippers for transporting viral vectors, the importance of comprehensive shipment monitoring, the advantages of rigorously requalifying every shipper after transport, and more.

Revolutionizing How Medicines Are Made, Funded, And Scaled

Virtually tour the process and analytical development laboratory and GMP manufacturing facility which includes four additional 2,000L single-use bioreactors.

SOLUTIONS

HLA Testing: Comprehensive Genotyping For Human Leukocyte Antigen

HLA testing is a crucial component of advanced therapeutics. Learn how leveraging a cell therapy-focused CDMO enables a true end-to-end solution and accelerates treatment timelines for patients in need.

Gene Therapy, Oncolytic Viruses, Viral Vaccines CDMO Services

Our gene therapy viral vector process development and manufacturing capabilities are designed to confidently and rapidly progress your products from gene to market through development of robust and reproducible cGMP practices.

GMP-Compliant Production Lines Of Plasmid

The OBiO Intelli-M GMP manufacturing site has three production lines of prokaryotic cell culture plasmid for commercial manufacturing, including a single-use whole process production line and two stainless steel production lines.

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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