03.20.23 -- Women Rising In Biotech

Data privacy will be a much bigger focus for small and midsize businesses in 2023, as stricter privacy legislation is enacted. Learn key reasons to review your privacy policy.

This regulation from the FDA outlined serialization and traceability requirements spread over the course of 10 years with preparation for each phase accumulating into a potentially high overall price tag.

This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

Mathematical models are recommended to generate enhanced process understanding and meet QbD guidelines. Explore the differences between statistical and mechanistic models along with their use in improving process development.

The increasing complexity of the drugs currently in clinical development has created mounting pressure for companies hoping to surmount the myriad of challenges that typify these therapeutic modalities.

In this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.

It is important to pursue a dualistic, longer-term supply strategy that embraces cost control and supply reliability/diversity to improve the integrity and resilience of international supply chains.

Understand why the demand for CDMOs with experience in the formulation of ophthalmic products is on the rise. 

Specializing in oncology, anti-infective, and complex formulations, this facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.

A pharmaceutical company was looking to partner with a CMO with commercial manufacturing capabilities, large-scale assets, multinational sites, and exemplary quality systems/U.S. FDA track records.

Discover how it worked to manufacture clinical supplies of flavored tablets with multiple APIs in just six months while ensuring content uniformity and stability.

This e-book describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality reviews.

Review helpful insights on critical quality attributes impacting plasmid DNA.

The benefits of continuous flow manufacturing are significant and numerous, and those benefits grow with each technological breakthrough and methodological advance.

Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit. 

Taste masking for children can present unique challenges for drug developers. Learn how we can use flavor not just to provide a desired taste, but also to provide taste masking.

Using the Cytiva SA25 Aseptic Filling Workcell, a standardized system designed with flexibility built in, ensures that companies can pivot between products quickly and adapt as manufacturing needs change.