Newsletter | March 6, 2025

03.06.25 -- Which Of These 6 Outsourcing Models Best Suits Your Program?

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Webinar: Shifting the Future of Drug Development with Advanced Analytical Characterization

Understanding the structural properties and impurities of biotherapeutic molecules is crucial for regulatory submissions and product development. As biotherapeutics become more complex, new analytical challenges emerge. This webinar covers advanced tools like mass spectrometry, biophysical characterization, and high throughput analytics to ensure safe, compliant medicines. Click here to learn more.

FEATURED EDITORIAL

Which Of These 6 Outsourcing Models Best Suits Your Program?

Outsourcing was once seen solely as a cost-cutting measure. Today, drug developers leverage it as a strategic advantage—gaining specialized expertise, enhancing manufacturing efficiencies, and strengthening their production teams to accelerate innovation and ensure quality.

Go Ahead, Outsource Your Entire Biotech

Persephoni BioPartners CEO Hilary Schultz has created a business model that may propel “externalization” to an ultimate implementation: The formation of a biotech by outsourcing the entire organization, which then outsources to advance an asset. Schultz describes Persephoni as a venture studio. Chief Editor Louis Garguilo investigates further ...

INDUSTRY INSIGHTS

Nuances Of Sample Preparation For UHPLC Testing In Early Phase Programs

In early-phase stability programs for drug development, precise sample preparation for UHPLC testing is crucial to ensure accurate and reliable stability data.

Mammalian Or Microbial? Choosing An Expression System For Your Product

Whether you’re trying to achieve speed and cost-effectiveness or higher yields and glycosylation capabilities, the right system can be tailored to meet the needs of each unique biologic.

From Formulation To Manufacturing: An Emerging Biopharma’s Journey

Partner with a CDMO that understands the unique challenges of emerging biopharma, providing expert guidance in formulation development, manufacturing, and regulatory navigation.

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.

Leveraging Digital Solutions To Reshape The CDMO Experience

CDMO customers consistently state that access to near real-time data is crucial to their ability to make timely, informed decisions, especially during early development.

Scalable Protein Expression With Pichia Pastoris

Explore the benefits of the XS® Pichia 2.0, including speed, simple fermentation regimes, and robust, scalable processes that can be tuned according to the specific objectives of a program.

Integrated Services For Cell Line Preparation And Storage

Utilize this comprehensive suite of services for the manufacture, characterization, and storage of cell banks as well as the advantages of working with an experienced partner.

CDMO Expertise Accelerates Biologics Development, Manufacturing

An experienced contract manufacturer can help drug developers to better utilize internal resources, leverage deep industry experience, and mitigate risk across development cycles.

ICP-MS And ICP-OES: Tools For Elemental Impurity Analysis

Leverage advanced elemental impurity testing methods to ensure the safety, compliance, and accuracy of your drug products throughout the manufacturing process.

SOLUTIONS

Proven Vial Containment That Scales From R&D To Commercial

Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.

Capacity Update January 2025: Fill/Finish

Discover 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.

BD Libertas Wearable Injector

BD Libertas™ Wearable Injector is designed to deliver subcutaneous injections of large volume (2-5 mL or 5-10 mL) and/or high viscosity (up to 50 cP) fixed dose biologics for the non-acute setting.

Potency Assay Development — Creating Potential Together

It is necessary to achieve a well-designed and developed potency assay as it is the only analytical technique that can demonstrate the biological mechanism of action and the link to clinical efficacy.

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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