Newsletter | September 11, 2024

09.11.24 -- Warning To U.S.-Based CDMOs: Don't Get Complacent

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Technical Excellence In ADC Manufacturing

On October 24, join industry experts for an exclusive series of cutting-edge presentations on demonstrating technical excellence in process development and manufacturing for ADCs and bioconjugates. Register to gain access to expert knowledge that will drive innovation and accelerate your ADC development and manufacturing program. Gain valuable insights on successfully scaling up from PAD to manufacturing, leveraging an integrated linker-payload supply chain, and implementing Process Analytical Technology (PAT). Register here.

FEATURED EDITORIAL

Warning To U.S.-Based CDMOs: Don't Get Complacent

How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

August 2024 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction 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.

No Strategic Outsourcing Without An Internal Strategy

Antiksha Joshi, Urmi Quality Management Consulting, and Reza Oliyai, Oliyai Consulting, stress the need to establish a coherent, internal outsourcing strategy at biotechs before looking to form strategic partnerships at CDMOs, and provide some examples.

INDUSTRY INSIGHTS

The Write Side Of AI: Augmenting Capabilities, Not Replacing Them

AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.

Understanding Quality Agreements Between You And Your Service Provider

An effective quality agreement communicates the responsibilities of each party in a clear, concise manner, allowing the reader to quickly and accurately determine to whom a specific responsibility is assigned. 

The Art And Science Of Pre-Picking Tablet Designs

Picking and sticking are the most common tablet defects that can reduce your product quality and performance. This makes perfecting the right pre-picking strategy essential to improving your processes.

Improving A Cancer Medication Using Innovative ASD Technology

Review the case study and learn how a novel solid dispersion technology lowered pill burdens and demonstrated an improved therapeutic response for Galeterone.

Recent Innovations And Enhancements To Pharmaceutical Spray Drying

Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.

SOLUTIONS

Method Optimization

We offer a comprehensive method optimization service to take early stage development methods with poor stability indication, excessive run time lengths, or legacy column chemistries and modify them.

Capacity Update July 2024: Small Molecule Finished Dosage Form

Douglas CDMO specializes in high-potency softgels and liquids and has deep experience producing prescription drugs for classifications including oncology, dermatology, the central nervous system, and immunity.

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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