Newsletter | March 20, 2025

03.20.25 -- February 2025 — CDMO Opportunities And Threats Report

INDUSTRY INSIGHTS

Virtual Quality Audits — Overcoming Pandemic Limitations

A properly executed virtual audit facilitates thorough qualification, condenses production timelines, enhances relationship-building, and provides early insight into a CDMO’s capability and expertise.

What Are The 5 Key Differences Between A Good CDMO And A Great One?

Market dynamics will continue to favor engaging with CDMO partners who have the capabilities and experience to manage short-term needs while anticipating and planning for long-term requirements.

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.

Top 3 Things Your Sterile Fill Finish Operator Wants You To Know

Sterile fill finish operations can be complex. Those on the floor handling these products every day answer the question, "What are the top things customers should consider when beginning this step?"

Optimizing Bioprocesses Using Functional DOE

See how combining Functional Design of Experiments (DOE) with traditional DOE methods enhances process optimization by capturing dynamic, time-based variations in cell culture systems.

Navigating Your Holistic Approach To CCI For Biologic Drug Products

Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.

Rapid Developability Assessments To Assist Lead Candidate Selection

Uncover how rapid, multidimensional assessments that optimize stability, manufacturability, and clinical success potential have been able to accelerate lead candidate selection.

CM Partnering For Adaptable, Accelerated Market Acceptance

The need for manufacturing support that offers adaptable, scalable solutions has become more crucial than ever for the diagnostic space.

FEATURED EDITORIAL

February 2025 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma collaborates with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

Outsourcing Reinvented: A Bold Strategy For Biotech Efficiency

Bob Discordia had been in stealth mode for a while. When he finally emerged, Chief Editor Louis Garguilo knew his newco would include a precise model of outsourcing. The reveal came earlier this year with the announcement he had founded EQUULUS Therapeutics, a neuroscience biotech. So how will Discordia outsource? He'll take an Uber ... and advises you do the same.

SOLUTIONS

Capacity Update January 2025: Large Molecule Development

Learn how our expertise and advanced capabilities provide customized analytical solutions that ensure quality, precision, and regulatory compliance for your biotherapeutics.

DNA2.0 - Gene Optimization And Synthesis

Building on DNA2.0's reputation for fast, reliable DNA synthesis, we use GeneGPS® and VectorGPS® to optimize constructs for your system, from single genes to complex bispecific antibodies.

OPCU January 2025: Large Molecule Development

Go on a virtual tour of our GMP-certified facility, where we uphold our expanded capabilities for large molecule development to the highest standards for clinical and commercial manufacturing.

Capacity Update October 2024: ADC

We've expanded our U.S. and Germany sites to offer end-to-end services for product development, clinical and commercial fill/finish, and ADC conjugation and purification by 2025.

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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