Newsletter | June 10, 2024

06.10.24 -- 4 Strategies To Formulate Poorly Soluble APIs

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New FDA QMSR: Its Role in Part 4 Compliance for Combination Products

The FDA’s release of the new Quality Management System Regulation (QMSR) significantly revises 21 CFR Part 820 Quality System Regulation and, in turn, Part 4 CGMP for combination products. Join us on June 26th as experts discuss the history and intentions of the new QMSR and what it means for combination product manufacturers and areas of risk your organization may need to address.

FEATURED EDITORIAL

4 Strategies To Formulate Poorly Soluble APIs

One of the toughest challenges facing small molecule drug development today is poor solubility of the API. No single technique has universal application, so several strategies exist. Examine four notable strategies.

INDUSTRY INSIGHTS

Overcoming Formulation Challenges For mRNA, High-Concentration Proteins

Increased demand for protein delivery and the emergence of advanced modalities – including mRNA – are introducing new challenges to the development lifecycle, such as high-concentration formulations.

Off-The-Shelf Vs. Novel Devices: Selecting A Drug Delivery System

Whether bringing a novel therapy to market or altering current devices, companies must determine the best selection for administration without impacting drug efficacy, quality, and safety.

PBPK Modeling For Optimized Controlled Release Formulation Development

Examine the benefits of controlled release, the application of PBPK modeling in formulation development, and how modified release products can be developed to deliver optimal patient outcomes.

Formulating Better ASDs And mAbs: Advances In Applied Nanotechnology

Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long acting injectables, inhalation, and ophthalmic.

Applying Automation To The Manufacture Of Drug Delivery Devices

Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.

How An Innovative Technology Is Disrupting Spray Drying

Review a commercially ready process that not only reduces manufacturing complexity and environmental impact but also holds the capability to out-design and outperform spray drying.

Innovating For Subcutaneous Delivery Of Large-Volume Complex Biologics

Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

SOLUTIONS

Modeling Platform To De-Risk Container-Closure Selection

End-To-End Oral Dosage Form Services From A Technology-Driven CDMO

Aidaptus Auto-Injector Manufacturing

Building Better Delivery Device Solutions Using Human-Centric Design