Newsletter | November 20, 2025

11.20.25 -- Is Passion A Criteria For Your CDMO Selection?

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Take a brief tour of Nanoform's advanced nanoformulation, nanoanalytical, and best-in-class capabilities. This video highlights Nanoform’s advanced characterization tools, state-of-the-art formulation technologies, and expert-driven solutions designed to tackle bioavailability challenges. Watch the video now.

INDUSTRY INSIGHTS

Fragmented Outsourcing: Difficulties Working With Multiple Siloed Partners

By working with a single supplier that can handle the entire manufacturing value chain, companies can reduce risk, improve flexibility, and accelerate their time to market.

Leveraging Bio-Functional Assays For Charged Variants Characterization

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

Onshoring Advantage: 7 Forces Reshaping Global Biologics Manufacturing

Policy, trade, and security pressures are fundamentally reshaping global biologics manufacturing. Uncover practical steps sponsors can take to de-risk their supply chains proactively.

FEATURED EDITORIAL

Is Passion A Criteria For Your CDMO Selection?

With a tinge of trepidation at being thought of as whimsical, I asked our Editorial Advisory Board: Can consideration of a CDMO’s passion play a role in due diligence for selecting a partner? Is there a qualifiable measurement (intuition?) related to a CDMO’s enthusiasm? I was surprised (and relieved) by some replies.

How Sethera Harnesses A Promiscuous Enzyme To Make Recombinant Peptides

As interest grows in chemoenzymatic approaches to drug development, we wanted to know more about Sethera Therapeutics’ approach. Here’s what we were told.

INDUSTRY INSIGHTS CONTINUED

5 Outdated Practices Holding Back Modern Bioanalysis

To support complex modern therapies, bioanalysis must replace outdated paper, manual processes, and disjointed systems with integrated, automated platforms.

Support Of Scale-Up And Technical Transfer Through Understanding Equipment

See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

Demonstrating Value Throughout The Product Development Lifecycle

Examine how a partner with extensive capabilities and expertise adds value to drug development and helps to solve complex formulation, analytical, and manufacturing challenges our clients face.

The Stage-Gate Model: A Proven Approach To Streamline Biomanufacturing

Learn how a Stage-Gate approach to technology transfer and biomanufacturing can help to mitigate risk while shortening cycle times throughout the project lifecycle.

Analytical Techniques For Assessing Quality Of Therapeutic Proteins

Evaluating quality attributes of therapeutic proteins requires a strategic, regulation-compliant selection of analytical techniques that consider molecular characteristics and phase to ensure characterization.

The Power Of The Pool: Using Bulk Cultures For Clinical Trial Manufacturing

Stable bulk cultures, made highly uniform using transposase-mediated technologies, may be the key to expediting clone selection for many biopharmaceutical applications.

Effective Procurement Strategies For Labeling Systems In Drug Manufacturing

What is actually behind the procurement of a pharmaceutical labeling machine and how does the process work? You can find out here what the path to your pharmaceutical labeling machine looks like.

Streamline The Path To FIH Trials With Advanced Cell Line Development

Many CDMOs cannot handle complex recombinant proteins, which often require a CLD process fully integrated with other CDMO components, including analytics and formulation development.

An Industry-Backed Approach To Container Closure Integrity

Ensuring container closure integrity in an increasingly complex pharmaceutical industry requires a holistic approach that incorporates quality control into all phases of product design and development.

SOLUTIONS

Pharmaceutical Commissioning And Qualification Services

GMP project delivery is a demanding endeavor. Find out why our skilled and well-managed teams, who use proven GMP information management software, are the right choice for your project.

Trusted End-To-End CDMO Partner For Your Journey

In an increasingly competitive environment, working with the right CDMO is vital for successful drug lifecycle management. We now serve more than half of the world’s leading biopharma companies.

Easy-To-Use 1 mL Disposable Autoinjector

Recognized by the Arthritis Foundation®, the BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.

Capabilities Update April 2025: Large Molecule Development

Site head Bill Hermans showcases our facility's specialized capabilities in Hopkinton, Massachusetts, and shares how our team serves as a true scientific partner to clients.

20 Years Of Sterile Manufacturing Excellence

Ensure the highest quality and sterility for your injectable manufacturing with proven aseptic expertise. Expect customer-first service, regulatory excellence, and a commitment to long-term success.

Capabilities Update January 2025: Fill/Finish

Watch how Lonza Biologics’ end-to-end Drug Product capabilities support the full lifecycle of biologics, seamlessly integrated with their extensive drug substance network across diverse modalities.

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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: