Newsletter | January 29, 2025

01.29.25 -- The Intelligent CDMO: A Vision With Agentic AI

SPONSOR

We're ready to help usher your next drug into market! 2025's first Outsourced Pharma Capacity Update provides a unique, virtual experience and the details necessary to find a CDMO for your specific timeline, volume, and production needs. Join us the last week of January as we draw the curtains on the industry's best and give you complimentary VIP access to the resources available to support your success. Learn more and register to save your seat!

FEATURED EDITORIAL

The Intelligent CDMO: A Vision With Agentic AI

Agentic AI is the next artificial-intelligence iteration for the biopharma industry. It propels prediction to autonomous decision-making. It can usher in transformative efficiencies to CDMOs. If you've day-dreamed of more effective external-support, this may be a ticket to that destination.

ASTM International Pharmaceutical Cleaning Standards: Status And Direction

Get an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

INDUSTRY INSIGHTS

The Rise Of Complex OSD Generics: Understanding Development Challenges

See why having an awareness of the potential pitfalls and partnering with the right experts can make all the difference in overcoming the complexities of complex generic OSD development.

Small Molecule API Production: Unveiling The Impact Of Fermentation

Tech developments have led to growth in the suitability of fermentation for a myriad of applications. Explore the impact of the evolution of synthetic biology and supporting technologies on modern practice.

The High Potent Market And The Role Of A Specialist CDMO

Safe handling of HPAPIs is complex and the associated regulatory requirements are growing. Discover how leveraging a CDMO can ensure treatments reach patients faster, safely, and cost-effectively.

Outsourcing Stability Storage: A Cost-Effective And Quality-Driven Approach

Partnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry to ensure product quality and compliance. 

Spray Drying Biologics: An Alternative To Freeze Drying

Uncover how innovative drying technologies can enhance the stability and efficacy of biologics, ensuring successful outcomes in this rapidly growing sector of the pharmaceutical industry.

Improving Solubility With Spray Drying

Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.

SPONSOR

Webinar: CMC and Clinical Strategies for the Successful Development of Injectable and Oral Peptide Drugs

Save the date for February 6th! Explore key drivers and delivery options for injectable and oral peptides. Learn strategies for transitioning from IV to subcutaneous delivery, phasing CMC investment, and minimizing risks. Hear insights from 14 oral peptide programs, PBPK modeling, and rapid pharmacokinetic prototyping to optimize development and meet target product profiles. Click here to learn more.

SOLUTIONS

Bridging Molecules From Early Discovery To POC And Beyond

Learn how partnering with us provides customer flexibility, dedicated project teams, and bespoke services customized for each development program.

Solid Form Services

We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program.

Commissioning, Qualification, Regulatory Compliance Services

Let us aid you in implementing innovative approaches to achieve higher quality, increased reliability, faster project delivery, reduced energy and operating costs, and meet regulatory compliance.

Formulation And Manufacturing Equipment

Our integrated GMP manufacturing services for oral dosage forms provide a full complement of analytical development and testing capabilities.

Biomarker Development And Assessment

Whether used for primary or secondary endpoints or in exploratory research, our seasoned scientists provide scientifically robust support to ensure the successful application of biomarker assays.

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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