Newsletter | July 24, 2025

07.24.25 -- Investors Create A U.S. Biotech With GLP-1 Assets From China

INDUSTRY INSIGHTS

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 it should be supported by all available data, as well as a thorough risk assessment.

Handling Protocols: Considerations In The API Market

Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

What Is Causing Limited Bioavailability

Discover how this label-free whole-body QMSI combined with plasma LC-MS/MS can help identify the root causes of limited bioavailability and guide smarter optimization strategies early in development.

FEATURED EDITORIAL

Investors Create A U.S. Biotech With GLP-1 Assets From China

U.S.-based Kailera Therapeutics formation is a revelatory story highlighting the prowess of today’s investor class. All four of its clinical candidates are GLP-1-based therapies. All were in-licensed from China. Kailera's CTO Doug Bakan fills us in on how it came together, and what's next.

Budgeting Key Component In Biologics Flexibility At CDMOs

You want flexibility in scheduling, contracts, and the entire CDMO relationship. While money can't buy you love, it can go a long way in getting that more flexible partnership.

INDUSTRY INSIGHTS CONTINUED

How Oral Therapies Are Revolutionizing Obesity Treatment

The rising severity of obesity has amplified a therapeutic need in healthcare. Observe as Dr. Srinivasan Shanmugam discusses the challenges and impacts of GLP-1 analogs.

The Assessment Of Nasal Delivery

Reconstructed nasal epithelium and CT-based 3D nasal casts provide more predictive, physiologically relevant models for assessing nasal drug delivery, improving accuracy in formulation development.

New Analytical Methods For Traditional And Unique Modalities

Review several challenges in biologics analysis and take a closer look at the advanced tools and methods being utilized to improve biophysical analysis reliability and efficiency.

Set Up And Qualify GMP Laboratories

Witness our established microbiology lab in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.

Novel Chromatography For Antibody Variants And Recombinant Proteins

Watch to uncover key considerations for developing purification processes for bispecific antibodies and learn about an innovative affinity chromatography technology for purifying any recombinant protein.

Strategic Biomanufacturing Partner For Multispecific Antibodies

A structured approach integrating technical expertise, advanced process solutions, and scalable, flexible infrastructure can address unique development and manufacturing challenges.

Obtain Proteins With Optimal Properties For Commercial Applications

Delve into the vast diversity and potential of proteins found in nature using a unique protein platform based on machine learning and design of experiments.

SOLUTIONS

Commercial/Clinical cGMP Quality Control Analysis

On-site labs with our own personnel offer greater control of samples and timelines, minimizing risk for our customers.

Capacity Update April 2025: Large Molecule Development

Leverage our proprietary non-viral gene insertion technology, ensuring rapid development timelines and high-yield production, making it an ideal solution for complex biologics.

in vitro Kill Rate Studies For Antimicrobial Screening

Utilize advanced studies to assess antimicrobial activity accurately, understand drug-microbe interactions, and evaluate the effectiveness of combination therapies.

Excellence In Every Injection.

We don’t just manufacture sterile injectables — we provide trusted partnership, operational excellence, and a deep commitment to getting life-saving therapies to patients safely, reliably, and on time.

Container Closure Integrity Testing

Our drug product services provide a holistic approach to DP development, preventing problems early and producing a product that is fit for purpose.

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: