Newsletter | October 27, 2025

10.27.25 -- Effective Supplier Management In Drug Delivery Development

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Developing new delivery routes for biological therapies is essential for creating more patient-centric and effective treatments. By using nanoforming techniques, it's possible to simplify dosing regimens and enhance patient comfort, compliance, and even reduce overall healthcare costs. Find out how this is best demonstrated through two real-world examples. Learn more

FEATURED EDITORIAL

A Companion Diagnostic Strategy For Combination Products

In the United States, the Office of Combination Products assigns primary jurisdiction for in vitro diagnostics (CDER, CBER, or CDRH). This article shares regulatory and commercial considerations.

Effective Supplier Management In Drug Delivery Development

This episode of In Combination offers considerations around supplier relationships in product development for combination products and other delivery devices. These include quality management, documentation, usability testing, regulatory pathways, post-market design changes, and other aspects of supplier controls. 

INDUSTRY INSIGHTS

Formulation And Evaluation Of Enteric Coated Aspirin Capsules

Enteric polymer coatings play a crucial role in oral drug formulations, protecting the API from harsh gastric conditions and enabling targeted drug delivery with optimized release based on location.

Layer By Layer: 3D Screen Printing And The Future Of Drug Development

3D screen printing can produce tablets across a range of release profiles, from conventional immediate release tablets to multi-compartment drug delivery systems that mix different release profiles.

Microphysiological Systems For Safety Testing In Personalized Medicines

MPS use human cells to model tissue function, offering faster, more predictive insights for drug discovery, safety testing, and personalized medicine — bridging gaps left by animal and 2D models.

De-Risking FDA ANDA Submissions: Disposable Pen For Liraglutide

BD’s Vystra™ Disposable Pen for Liraglutide 3.0 mg demonstrated comparable usability to the reference device, helping de-risk ANDA submissions through proactive human factors evaluation.

Utilizing Multiplex ddPCR To Streamline Viral Gene Therapy Workflows

Analytical technologies like Droplet Digital PCR (ddPCR) provide a more rapid and robust approach to nucleic acid quantification for better sensitivity, accuracy, and precision in therapeutic development.

Computational Modeling Of Injection-Related Tissue Responses

Optimizing delivery along with the formulation is the key to successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force, and needle length.

Vial Adapter Transfer Device Compatibility With Cell Therapies

Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.

SOLUTIONS

Bionanoparticle Technology

Supporting GLP-1 And Peptides With Integrated Solutions

Fill-Finish Capabilities Update