Newsletter | April 8, 2025

04.08.25 -- Training Specifically For Tech Transfer Skills Does Exist

SPONSOR

Webinar: Keeping Hope Alive: Transforming Rare Disease Drug Development for a Faster Cure

Join us on April 15th to explore how the rapid development of COVID vaccines sets a precedent for curative therapies for rare diseases. Learn how CDMOs expedite workflows, streamline manufacturing, and ensure reliable, scalable processes. Discover how supporting analytics and robust strategies accelerate the development, commercialization, and timely delivery of life-changing gene therapies. Click here to learn more.

INDUSTRY INSIGHTS

Optimizing Cell Therapy Development: Part 2

Plan early and align research, development, and commercial priorities to ensure a seamless transition from clinical development to scalable, cost-efficient commercialization.

Unlocking The Future: Exploring Cutting-Edge Cell And Gene Therapies

Explore the transformative potential of cutting-edge cell and gene therapies, focusing on CAR-T cell therapy, CRISPR-Cas9 gene editing, and other advanced approaches.

Improving Viral Vector Production Through Addressing Complexity

In a recent webinar, Novartis Contract Manufacturing experts explored innovations in viral vector manufacturing and addressed production challenges and quality control strategies.

FEATURED EDITORIAL

Training Specifically For Tech Transfer Skills Does Exist

Professionals in our development and manufacturing outsourcing ecosystem are worried about inadequate training – in-house at their biotechs, and at their CDMOs. A main concern is a lack of sufficiently trained personnel to perform the various technology transfers to keep our industry running efficiently.

The Costs Of Disengagement From China

If we ever did implement (suffer through?) some rather large-scale “disengagement” between the U.S. and China in the biopharma industry realm, what costs would we incur?

Alternatives To Testing Sterility In Cell- And Tissue-Based Products

Testing depletes precious product, and regulators increasingly support using other methods if they're backed by robust validation data.

INDUSTRY INSIGHTS CONTINUED

Comprehensive Pathway To Seamless Scale-Up Of mRNA DP Manufacturing

An integrated approach to mRNA drug product manufacturing helps to accelerate drug development, mitigate risks, and ultimately deliver life-changing therapies to patients.

Developing An mRNA-Encoded Antibody Platform To Accelerate Therapies

In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.

Recommendations For Successful IND Approval Of RNA-LNP Drugs

The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

Scale-Up Allogeneic Cell Therapies To Large Patient Populations

Achieve your therapeutic and commercial goals by utilizing a tried-and-tested standardized approach combined with the latest technology and reliable analytics.

Strategies For Engineering Mammalian Cells

Using cells with a pre-engineered TARGATT™ landing pad, we achieve inducible expression within just 4-6 weeks after donor plasmid creation, significantly reducing development time and effort.

Navigating The Allogeneic Commercialization Journey

Review the pivotal moments, challenges, triumphs, and lessons learned that have shaped an evolution from facility construction to a fully operational, patient-focused CDMO.

SOLUTIONS

A New Horizon In AAV cGMP Gene Therapy Manufacturing

For cell expansion to occur, we use the world-leading cell line: Pro10™ by AskBio. Viralgen is the only company in the world with a license to manufacture for third parties.

With Passion We Bring Pharmaceutical Solutions To Life

By combining technical excellence with a passion for progress, we enable our customers to bring life-changing therapies to market efficiently and reliably.

Toxicity Studies

Utilizing statistical analysis and a proprietary metabolomics database, see how we detect and identify molecular toxicity markers, providing critical safety insights into potential drug candidates.

What We Do

From early pre-clinical phases into the clinic and out on the market, we understand that consistent product quality is not negotiable and work to get it right early on.

Analytical Services And Quality

Our robust analytical capabilities support development processes and ensure our products are well characterized, safe and meet regulatory guidelines.

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: