Newsletter | May 14, 2025

05.14.25 -- Mastering Tech Transfer, CMC, And CDMO Strategy — A Must-Read Guide

SPONSOR

Webinar: A New Look at Subcutaneous mAb Delivery Using Nanoformed Particles

Subcutaneous (Sub-Q) delivery offers self-administration and fewer hospital visits but is challenging for high-dose biologics. Nanoform developed a concentrated, non-aqueous Sub-Q IgG1 suspension using its patented dry particle platform. The study evaluated particle size impact, formulation properties, protein quality, and stability, with pharmacokinetic studies ongoing. Key topics include Sub-Q benefits, Nanoform’s dry particle process, and non-aqueous suspension formulation. Click here to learn more.

INDUSTRY INSIGHTS

Step-By-Step Guide To Tech Transfer Preparation And Execution

How does a sponsor accurately transfer detailed knowledge about its product composition, development, and current manufacturing processes to its CDMO?

Early Solid Form Screening To Guide Drug Development

Conducting solid form screening early can help your team select and isolate the ideal lead polymorph to ensure manufacturability and stability while avoiding costs and hiccups down the road.

Costs And Risks Associated With In-House Stability Storage

By performing stability storage in-house, you are taking on several risks. Find out how you can eliminate stability storage risks and save your resources and finances.

FEATURED EDITORIAL

Lynn Cinelli's Wake-Up Call: Pharma's Forecasting Makes CDMOs Sick

Lynn Cinelli, VP Global Biologics Supply Chain at Bristol Myers Squibb, has been strategizing on why Pharma is so poor at forecasting demand. "The entities that feel the pressures most may be our CDMOs,” she says. She has a better way to go about it — and it starts with the patient.

The Expanding Role Of CMC In Biotech Investor Decision-Making

With increasingly complex modalities, undruggable targets, rare diseases, and narrowly defined patient subpopulations, CMC is an important area of due diligence scrutiny for prospective investors and licensees. Part 1 of a two-part analysis.

INDUSTRY INSIGHTS CONTINUED

PBPK Modeling: Mitigating Absorption Risks In Early Drug Development

Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.

Reducing Risks By Outsourcing OSD Manufacturing And Packaging

Uncover the key benefits of outsourcing your OSD production and review real-world examples and best practices to help you streamline your processes and enhance your operational agility.

A Solvent-Free, Fusion-Based ASD Manufacturing Process

Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.

SOLUTIONS

Medicinal Chemistry — India

Our business model doesn't add additional costs to your project. Review our network's medicinal chemistry capabilities and contact us to simplify your outsourcing solutions.

Nasal Spray Development And Manufacturing Services

A partner with experts who are adept at working with complex, sensitive, and potent APIs; screening for the optimal formulation; and scaling up efficiently is vital for successful trials and commercialization.

South Haven cGMP Manufacturing Services And APIs

Learn how our chemical manufacturing facilities are equipped to support a wide range of projects with on-site pilot plants and large-scale commercial capabilities for manufacturing high-quality APIs.

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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