03.01.24 -- Is WuXi Apptec An Enemy Of The State?

Expedited regulatory pathways are being used more often, even as small molecule pipeline candidates grow in complexity, creating new risks for drug developers. Join Outsourced Pharma Live March 14th for a discussion with small molecule biopharma executives on the key considerations for CDMO selection, pitfalls to avoid with service providers, and tips for getting to the next development milestone.

In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.

Understand the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.

Nasal spray administration of medicine offers advantages over oral and intravenous (IV) delivery. Experts discuss the advantages and opportunities of adopting unit- and bi-dose nasal delivery technology.

Experts discuss the challenges they encounter in formulation development and tips on mitigating them to facilitate IND application and advancement along the development pathway.

We share important factors to consider when weighing your contract service provider options. These “Three Cs” can indicate whether a service provider has the capabilities desired by a drug sponsor.

Dysphagia impacts treatment compliance and affects the elderly. Learn how microencapsulation-enabled formulation of a soluble powder drives patient adherence.

The 8th CCP Summit offers a content-rich experience with cutting-edge presentations from leading pharma and biotech, covering content across small molecules, biologics, and ATMPs. This forum will harmoniously pair technical case studies with the business case realities to leave you with the definitive answer of why NOT continuous processing. Download the full event guide to learn more.

We have defined work flows to assess and select solid forms in a cost- and time-efficient manner that meets the needs of each individual program.

As the pharmaceutical industry innovates and evolves, learn more about how Nanoform can play a critical role in empowering your company's journey to net zero.