01.24.23 -- Frequent Deficiencies In GMP Inspections

During a company's nanomedicine development program, selecting the right drug delivery technology is key. Deciding which is most suitable for an API must be determined by a complex array of factors.

Explore the typical supply chain challenges faced by global CROs and CDMOs and how one company has transformed its supply chain to mitigate these risks and turn them into a competitive advantage.

Managing today’s supply chain complexity begins by transforming historically transactional relationships to those that drive suppliers to value-added status, working toward shared customer goals.

To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

Since procuring equipment for your facility is a critical step for any manufacturing organization, it is in a manufacturer’s best interest to turn to an organization that can serve as a strategic procurement partner.

The more efficient your API synthesis, the lower your cost of goods. The author shares his tricks of the trade for route selection, equipment choice, manufacturing techniques, and more.

Discover how to identify characteristics at the earliest stage, a vital step in autoinjector device platform development, with the use of the innovative injection characterization system (ICS).

This series of frequently asked questions covers the research and design mindset applied to the development of the BD Neopak™ XtraFlow™ solution and the anticipated clinical benefits of 8 mm needles.

More than ever, the quality functions in biopharma manufacturing are under pressure due to regulatory and political scrutiny combined with a global market rife with complex quality standards.

We discuss three enabling technologies designed to improve drug solubility in organic solvents for spray drying and define the advantages and risks of each technology.

Learn about key product parameters affecting patient acceptability and therapy adherence, and taste masking strategies, including organoleptic and barrier coating approaches and microencapsulation technologies.

Substitution is the essential starting point in every risk assessment. Learn how to conduct a legally compliant substitution check using real substances as examples.

This webinar focuses on moving the HPAPI powders through the entire process, starting with chemical synthesis of the molecule to finishing in multiple solid dosage forms.