04.23.24 -- FDA Publishes Final Guidance On Reporting Listed Drug Amounts

The first critical step in your digital journey, before implementing AI, is to ensure you’re at the right level of digital maturity.

In this podcast episode on Annex 1 compliance and gap assessment, Patrick Nieuwenhuizen shares his insights and expertise gleaned from extensive experience in pharmaceutical regulation and compliance.

From fully developed large-scale manufacturing and packaging to a single development batch, a contract services organization must be prepared to handle multiple compounds in the same facility.

Once a company has demonstrated proof of concept, it is critical to consider process elements like scalability, sourcing raw materials, and GMP adherence.

A strategic partner should seek innovation that improves your compound or product’s value. Pfizer CentreOne’s Tom Wilson shares tips for picking the perfect API partner.

New higher volume, higher viscosity pharmaceutical formulations for subcutaneous injection, alternatives to traditional intravenous treatment, enable chronic disease therapy in alternate settings.

Advancements in cell line development workflows have created the potential for greater standardization and automation, eliminating the most common workflow bottlenecks and improving reproducibility.

Sustainability is a growing issue in the pharmaceutical industry. Review strategies for reducing your carbon footprint and learn how the right CDMO can help drive the sustainable manufacture of APIs.

Among the numerous benefits of N-1 technology-backed CM are reduced bioreactor size, standardized sizes, a simplified process, and the potential to utilize single-use bioreactors (SUBs).

Discover the challenges pharma companies are facing as they switch focus as well as the actions and technologies companies are implementing to help achieve a brighter future for patients.

Innovative drug-eluting implants, inserts, and transdermal films delivering biologics and small molecules can meet the goals of patient-centric therapies, improved medicine, and better healthcare economics.

Drug developers must successfully navigate the path to market under the growing pressure of regulation and competition, while carefully managing technical and financial risk.