Newsletter | August 5, 2025

08.05.25 -- Tech Transfer 2025 – A High-Stakes Game Of Trust

INDUSTRY INSIGHTS

How-To Master Tech Transfer: Strategies To Sidestep Common Pitfalls

Ensure a smooth and efficient technology transfer by following key strategies to streamline your process and achieve consistent, error-free results.

Accelerating Gene Therapy Development For NEDAMSS

Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

Signature Of Base Editor RNA Edits And Reduced Exogenous RNA Editing

Learn how this groundbreaking method for distinguishing base editor-induced RNA edits can enhance the safety and efficacy of genomic medicines.

FEATURED EDITORIAL

Tech Transfer 2025 – A High-Stakes Game Of Trust

Trust us. You'll want to read this editorial from Chief Editor Louis Garguilo, who was (gently) reminded he hadn't visited the subject of tech transfer in a while. He answers the questions both sponsors and CDMOs ask to gain the trust to make a tech transfer work for both sides.

Advanced Manufacturing And CDMOs Are Rewriting The CGT Cost Equation

Without contract manufacturers, small biotechs often don't stand a chance of reaching commercial production scales, let alone global access for their drugs.

INDUSTRY INSIGHTS CONTINUED

Nanomedicine Modalities Find Path To Clinic Through Analytics

Lipid nanoparticles have revolutionized drug delivery, ushering in a new era. Observe how advanced analytical tools are accelerating the development of next-generation LNP therapeutics.

How A Sponsored CMC Platform Optimizes mRNA Projects Into The Clinic

Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.

Impact Of Media Selection

Review a study conducted to assess the effect of three commercially available cGMP-grade media and their influence on T-cell phenotype.

Powering Cell Therapy Access: Louisville, KY's Unique Position

Uncover why this area is poised to become a leading hub for cell and gene therapy, as highlighted by CCS and industry experts at the 6th Annual Supply Chain Summit.

Protect Patients, Ensure Regulatory Compliance With Impurity Control

Examine a sponsor’s commitment to rigorous impurity control throughout manufacturing, as it is vital to ensuring continuous patient safety. 

Setting The Standard For Plasmid DNA Production

Witness how our expertise plays a pivotal role in developing genetically engineered pharmaceuticals, which can propel your innovative therapies forward and transform patient care.

Developing Scalable, Global Solutions For Manufacturing

Cell and gene therapies offer transformative potential for treating complex diseases, but their manufacturing and global delivery face significant challenges.

Boosting CMC Regulatory Efficiency In Gene Therapy

Guarantee your business stays ahead in today’s complex regulatory environment by implementing robust affairs strategies that streamline compliance and product approvals.

SOLUTIONS

Viral Clearance Services

Establish safety with expert-led viral clearance studies. Our global team delivers regulatory-compliant, scientifically robust solutions to eliminate viral risks and support the success of your product.

Minimizing Variability In Cellular Starting Material

Immunotherapy is an evolving and promising cancer treatment that works by stimulating the immune system. However, they are not fully representative of what is going on in vivo.

Powering Progress With High-Performance

Accelerate your gene therapy pipeline with our cost-effective, high-quality lentiviral vectors, optimized for clinical and commercial success.

Optimizing Therapy Through Seamless Formulation

Delve into our focus on selecting the correct buffer and excipient combinations, conducting thorough stability testing, and confirming device compatibility and dosing procedures.

Mammalian Services

Our deep expertise in cell line development, process optimization, and scalable GMP manufacturing ensures high-yield, high-quality protein production tailored to your therapeutic goals.

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: