Newsletter | June 5, 2025

06.05.25 -- Outsourcing GLP-1 Programs: Is There Capacity For Biotechs?

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

Why Cell Line Screening Is Crucial For Successful CDC Assay Development

In developing a CDC assay for therapeutic mAb characterization or QC release testing, consideration should be made to the expression of CRPs on the cell surface.

The Value Of Engaging A Single CDMO For Comprehensive Biologics Services

By forging strategic partnerships with comprehensive CDMOs, see how emerging biopharma firms can navigate through early-phase development and ensure a smooth transition to clinical advancement.

Leveraging Platforms To Create Vaccines At Pandemic Speed

Learn about the University of Queensland's rapid development of a vaccine candidate for COVID-19 and the role GS Xceed® system played in this project.

FEATURED EDITORIAL

Outsourcing GLP-1 Programs: Is There Capacity For Biotechs?

CDMOs want GLP-1 projects. Doug Bakan of Kailera Therapeutics says, “We see companies growing their existing GLP-1 manufacturing capabilities or communicating plans to introduce them. Our job is to find out which in fact have capacity now, and that vision to continue to expand.

AI's Potential To Aid Multispecific Analytical Characterization

Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.

 

INDUSTRY INSIGHTS CONTINUED

Regulatory Considerations For First-Time Drug Developers

Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO that can provide the regulatory, clinical, and CMC expertise needed to move your therapeutic forward.

Tactics For Successful Upstream Manufacturing Process Scale-Up

Scale-up challenges often arise when bioreactor geometry, design, mixing, or sparging differ from those used in initial process development, potentially compromising cell culture performance.

Why Biotechs Are Expanding In Combination Product, Drug-Fill/Finish

We're doubling down on growth, expanding its capabilities in combination product and drug-fill/finish manufacturing to meet the evolving needs of the biotech industry.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically improve your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

SPONSOR

Join Outsourced Pharma Live on June 11th at 2pm ET for a virtual panel discussion on the specific challenges of biologics development that must drive CDMOs to embrace more flexible approaches. Registration is free thanks to the support of Curia.

SOLUTIONS

Integrated Biotech Services: From Strain To Commercial Product

Backed by more than 30 years’ expe­rience and expertise, we offer our customers a full “one-stop-shop” service package at all stages of development and production.

Cell Line Development Solutions

Discover technology that enables a cost-effective, easily implemented cell line development workflow while delivering high productivity pools and cell lines.

International Supply Chain Management

Utilizing Singota's International SCM services involves cost savings, risk mitigation, logistics support, and streamlined communication.

Building The CDMO Of The Future

The kojoX philosophy is designed to overcome capacity constraints, regulatory complexities, and geopolitical risks to deliver unmatched scale, speed, supply chain agility, and resilience.

Capacity Update April 2025: Fill/Finish

Committed to customer-focused solutions, we’re proud to introduce our specialists to the global biopharma community and share insights that drive innovation forward.

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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