Newsletter | October 14, 2025

10.14.25 -- Paying For Lots Of Formulation Work At Your CDMO

SPONSOR

Webinar: Unlocking Allogeneic Cell Therapy: Exploring Durable Approaches

Join Applied StemCell's webinar with Ruby Tsai, Ph.D., to explore how developers are tackling durability challenges in allogeneic cell therapies. Gain insights into approved therapies, treatments in clinical trials, and novel approaches still in development. Learn how genome engineering and iPSC technologies are enabling scalable, cost-effective solutions that could transform accessibility and impact in the future of cell-based therapies. Click here to learn more.

INDUSTRY INSIGHTS

Synergies Between Vaccine Development, Manufacturing C&G Products

Understanding these synergies and their impact on efficiency, safety, and cost-effectiveness is essential for stakeholders navigating the complexities of cell and gene therapy development and production.

Navigating Complex Testing For Viral Vector-Based Gene Therapies

To ensure the success of gene therapy, learn why it is crucial to partner with a contract research organization that can navigate the challenges of viral vector development and testing.

Extractables, Leachables, And Risk: Ensuring Safety In Pharma Manufacturing

This session is designed for teams developing new products, optimizing processes, or preparing regulatory submissions, and provides practical tools for a better approach to E&L management.

FEATURED EDITORIAL

Paying For Lots Of Formulation Work At Your CDMO

We’ve investigated the outsourcing of early-to-commercial drug formulation. So how do you pay for all that work? For answers and examples, again, we've turned to Dileep Boinipally. He starts with the "usual method of payments" — fee-for-service (FFS), but adds a whole lot of options and strategies.

The Criticality Of Biannual Overview Meetings With Your Suppliers

Daily communication and periodic project- and individual team-level meetings are important. But according to one outsourcing professional with decades of experience, do not overlook the importance of biannual (or quarterly) meetings to ensure outsourcing success.

INDUSTRY INSIGHTS CONTINUED

Windsor Framework: What Is It?

Learn about the Windsor Framework and how it addresses the challenges of medicine supply chains between the UK and the EU, creating stability and certainty in the post-Brexit world.

Accelerating Your Gene Therapy: Not All Platforms Are Created Equal

Standardized methods, materials, and analytics are critical for overcoming hurdles in the gene therapy space. Explore how a platform approach to fast-track AAVs can enhance quality and efficiency.

The Key To Faster RNA-LNP Drug Development

Accelerate mRNA drug development by leveraging pre-optimized ionizable lipids and reagent kits that streamline early-stage hurdles and speed candidates to the clinic.

The Future Of Allogeneic Cell Therapy: Hypoimmunogenic Donor Cells

Follow along as President and Chief Scientific Officer, Ruby Tsai, Ph.D., explores innovative strategies for developing hypoimmunogenic cells, a critical advancement for the field of allogeneic cell therapies. 

AI For Faster, Smarter Gene Therapy Development And Manufacturing

Here, we highlight real-world applications of AI in gene therapy, providing case studies and addressing the challenges and prerequisites for successful implementation.

Proud To Be Part Of ARM: Advancing The Future Of Regenerative Medicine

With hundreds of members spanning over 25 countries, ARM serves as a hub for innovation, policy development, and cross-sector collaboration in regenerative medicine.

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.

Unlock The 3 Keys To Drug Discovery Success — Foresight, Hindsight, And Insight

If you don’t know where you are going, how will you get there? Articulating the destination of your therapeutic is essential for determining whether it is commercially viable and meets required milestones.

SPONSOR

Webinar: From Plasmids to Cell-free DNA using Megabulb DNA

This Touchlight and ElevateBio webinar explores how non-viral methods are transforming T cell engineering by overcoming cost, safety, and scalability challenges of viral transduction. Speakers highlight CRISPR-based editing with mbDNA™ paired with Life Edit’s LEG14 nuclease. Data show mbDNA™ enabled efficient, precise TCR knock-in with superior performance over Plasmid (next generation circular double stranded) offering a scalable path to next-generation T cell therapies. Click here to learn more.

SOLUTIONS

Groundbreaking Cryogenic Freezer Technology

Consider the benefits of a new cryogenic storage tank and how this innovative technology will mitigate risk in the cell and gene therapy supply chain.

Driving Innovation And Scalability In Advanced Therapies

By fostering strong collaborations and maintaining flexibility, BaseCamp is preparing for the complex landscape of commercial manufacturing while prioritizing quality, efficiency, and patient access.

Moving Cell Therapy Innovations From Lab To Market Quickly

Cell therapies hold immense promise, but navigating the development process can be daunting. A strategic partner can bridge the gap between early-stage innovation and successful commercialization.

Progressing Your Virotherapy Seamlessly

As an experienced global CDMO, we're dedicated to meeting your evolving virotherapy development and manufacturing needs through a collaborative approach.

Gene Therapy Manufacturing Support Designed To Optimize Yield, Quality

Advance your biologics from preclinical to commercial stages with a flexible CMC platform backed by global development labs and scalable GMP manufacturing capacity.

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

Focusing on critical parameters such as cell culture conditions, viral vector yield, and downstream purification strategies, can drive the success of scale-up and scale-down models for AAV production.

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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