04.16.25 -- What Biotechs Learn From Takeda's Internal Manufacturing Competition

Transitioning oral solid dosage (OSD) forms from Phase 1 to Phase 2 clinical studies demands effective strategies and solutions to overcome formulation and development challenges. This white paper explores practical techniques to refine formulations, manage Phase 1 outcomes, and optimize timelines. From navigating PK/PD results, addressing sub-optimal data, and advancing formulations, the paper discusses methods that support development, minimize risks, and prepare for regulatory and clinical milestones. Read more...

By integrating scientific rigor, regulatory foresight, and market awareness into early-stage planning, companies can leverage a robust TPP to optimize decision-making and development.

Some drugs violate multiple Ro5 elements but remain developable, while some molecules adhere strictly to the Ro5, but their properties are not conducive to development.

With so many different media available that vary widely in properties and composition, it is important to know how to select a dissolution media that can effectively test formulation robustness.

The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

Advances in peptide drug delivery have opened new opportunities for peptide drug products, with non-parenteral routes of administration — such as oral and nasal — now feasible.

Delve into the evolving landscape of pediatric dosage forms, with a focus on how ODTs are emerging as a specialized and practical drug delivery system for children.

We know how tough it can be to find the right CDMO, especially when capacity is tight and timelines are critical. That's why we're bringing together 31 CDMOs for our Outsourced Pharma Capacity Update Partners Week — a chance to explore their latest capabilities and available capacity, all from the convenience of your screen. Learn more about our sessions grouped by modality to join us to find the right partner for your project.

Our innovative business model won't add additional costs to your project. Review our network's API capabilities and contact us to simplify your outsourcing solutions.

Dr. David Rowe, Head of Manufacturing at Nanoform, provides an overview of Nanoform's manufacturing capabilities and introduces a new, state-of-the-art nanotechnology facility.

Equipped with advanced isolator and RAB technologies, our aseptic filling facilities feature multiple filling lines capable of producing liquid and lyophilized vials as well as prefilled syringes.

Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches.