02.18.25 -- Computer Systems Validation Pitfalls, Part 4: Inattention To Details

Here, we explore the key elements of a robust compliance culture, including leadership commitment, clear policies and procedures, and employee empowerment.

Uncover how tablet debossing aids medication identification and must meet FDA standards. Font, scale, color, shadow, and stroke details are key for optimal legibility and safety.

Gain insight into the implications of the shift to the European Medicines Agency's Pharmacovigilance System Master File (PMS) database for the pharmaceutical industry.

In response to a 2023 Open Letter from leading pharma companies, CDMOs are determining how to adapt their SOPs to improve sustainability and reduce CO2 emissions.

Learn about the global impact of pharmacy compounding, which plays a critical role in mitigating drug shortages and providing personalized medication solutions when commercial drugs are unavailable.

As the biotech industry has grown exponentially, so has the number of FDA clinical holds. Biotech companies need strategic planning to avoid or quickly resolve costly clinical holds.

A CDMO’s manufacturing science and technology (MSAT) plays a crucial role in optimizing a biomanufacturing process to meet the needs of the modern healthcare landscape.

Optimize your oligonucleotide processes with an expert-backed checklist that covers key equipment considerations, troubleshooting tips, and best practices to enhance your workflow efficiency and yield.

Gain insights into a platform for creating injectable and implantable long-acting drug delivery products, including its technical basics and how it can be used to deliver small molecules, peptides, and biologics.

Delve into the complexities of scaling decisions as well as strategies for avoiding common pitfalls during scale-up from biopharma developers and a CDMO.

Explore how modern advancements can improve the efficiency of microbial air sampling while minimizing the chances of false positives in cleanrooms.

Depending on the protein or peptide of interest for your therapeutic and manufacturing goals, there are a number of different approaches that can prove advantageous. Learn more about these various methods.

Discover a platform that consists of several technologies allowing for the cultivation and monitoring of CHO cells in cell line development. Find out how to set up your experiment on this device.

By leveraging the country's regulatory advantages and partnering with a New Zealand-based CDMO, international companies can accelerate approvals and navigate the regulatory pathway with ease.