Newsletter | June 9, 2025

06.09.25 -- To Enhance Biotech Investments, Involve CDMOs Early In CMC Decisions

SPONSOR

Webinar: Understanding the critical role of developability assessments to enable effective lead candidate selection

Discover how developability assessments can streamline lead candidate selection in this Abzena webinar. Learn how evaluating key attributes like manufacturability, safety, and efficacy early in drug development helps reduce risks and improve clinical success rates. Explore advanced methodologies and technologies that provide comprehensive insights, enabling better decision-making and more efficient progress toward regulatory approval. Click here to learn more.

INDUSTRY INSIGHTS

Upstream Optimization Paved A Straightforward Path For Full Capsids In AAV6

Because clinical applications for AAV are increasing rapidly, there is a high demand for further increasing yields as well as product quality, particularly for a higher percentage of full capsids in the final product.

Analyzing The Need For An Engineering Run: A Risk-Based Decision

Executing or skipping an engineering run is a consequential decision for any biopharma or CDMO and should be supported by all available data as well as a thorough risk assessment.

3 Key Trends Shaping The CDMO Industry

Stay up to date on the future of CDMOs by reading about key trends, such as adopting a customer-centric mindset, agile manufacturing, and embracing digitalization.

FEATURED EDITORIAL

To Enhance Biotech Investments, Involve CDMOs Early In CMC Decisions

In Part 1, we introduced the critical link between CMC and prospective investors and/or licensees. Here we conclude with suggestions for how CDMOs can lend expertise early in discovery/development to improve the probability of securing investment or license for their clients.

A Brief Intro To CMC Compliance Through CDMO Collaborations

Chief Editor Louis Garguilo provides a brief introduction and background to our Outsourced Pharma Live Event: CMC Compliance Through CDMO Collaborations.

INDUSTRY INSIGHTS CONTINUED

Pairing Robust Analytical Methods With Efficient Process Development

Analytical method development is a critical phase in development, and its successful implementation is essential for delivering high-quality products to market efficiently and effectively.

CMC Strategies For Multi-Specific Immuno-Cytokines, Enzymes

Discover how implementing a strategic approach to optimize the platform can establish a solid foundation for the efficient, reliable, and successful manufacturing of biopharmaceutical products.

Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

Utilizing Fed-Batch Intensification To Increase Titer In Biologics Manufacturing

Learn how the advanced principles of process intensification can be applied to process and equipment design, increasing facility throughput, and ultimately offering a wide range of benefits to customers.

Mastering QbD For Process Validation Campaigns, Commercial Manufacturing

In this presentation, industry-leading bioprocess experts explore the challenges and opportunities that arise when implementing Quality by Design (QbD) in biologics development and manufacturing.

SPONSOR

Webinar: Transposase-Enabled CLD: From Transfection to High Titer with Ease

Join KBI Biopharma for a webinar on transposase-enabled cell line development. Built on Selexis® SUREtechnology™ and CHO-M™, this platform delivers high titers, rapid development, and stability for complex biologics. Learn how it accelerates timelines, supports diverse molecule formats, and meets regulatory demands—offering a scalable, efficient alternative to traditional CLD methods. Perfect for teams seeking speed, quality, and flexibility in biotherapeutic development. Click here to learn more.

SOLUTIONS

Developing A mAb For A Small Biotech Developing Precision Medicines

See how Corvus, a small biotech, was able to advance Mupadolimab from development to clinical trials, leveraging flexible capacity, proven antibody platforms, and regulatory-ready CMC support.

Autoinjector For Deep Intramuscular Delivery

ArQ®-Vita enables reliable, large-volume intramuscular delivery in a compact, patient-friendly device — ideal for chronic condition treatments.

Specialized Scientific Expertise From 2 Centers Of Excellence: US, Canada

Review how our state-of-the-art instrumentation, technology, and scientific expertise are capable of supporting all aspects of biologics testing across all modalities.

Flexible Manufacturing Solutions, Services To Meet Evolving Industry Needs

Take a look at our full range of support services to streamline manufacturing processes through to the commercialization of aseptic and lyophilized products.

A Broad Design Space For Agile Development To Support Your Time-To-Market

BD Neopak Glass Pre-fillable Syringe is built on years of BD’s unmatched experience partnering with leading biopharmaceutical companies to support drug development and launch. 

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: