02.13.25 -- Addressing Blind Spots In Assuring Therapeutic Equivalence

For complex projects involving oral solid dosage (OSD) and sterile drug products, selecting the ideal CDMO can play a pivotal role in determining the success of a drug candidate. Learn more here. 

Discover why a strong commitment to operator training is essential to prevent production issues, ensure product quality, and safeguard patient safety.

Advances in different therapies require a rethinking of cleanroom manufacturing facilities. What factors lead to successful entry into the commercialization of new therapeutic production capital projects?

Successful migration to a new HPLC system can be challenging. Review the gradient USP method for Quetiapine Fumarate Impurities analyzed on two legacy HPLC systems and on modern technology.

Learn how a physicochemical-based approach can help to accelerate the development of bioanalytical assays for insulin analogs, avoiding delays and increasing efficiency in clinical trial processes.

Explore the power of headspace gas ingress in ensuring product quality. Dr. Derek Duncan, Director of Product Lines, Lighthouse Instruments, reveals the golden tool for container closure integrity testing.

The most common cause of downtime is the use of incorrect or out-of-date equipment. Delve into considerations for improving your processes and increasing productivity.

Follow trends that are transforming the industry, explore common speedbumps on the road to innovation, and learn how a new platform offers unprecedented process transparency and continuous improvement.

Discover how isothermal microcalorimetry (IMC) rapidly screens API-excipient compatibility, detecting physical and chemical interactions faster than conventional methods.

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.

In today's fast-paced production, precision checkweighing is crucial. Find out how smart algorithms, real-time analysis, and automation optimize performance and minimize downtime.

Uncover how pharmaceutical companies now have a wearable solution designed to enable new delivery formats in alternate settings and customization to support adjustments. 

Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

Digitalizing commissioning, qualification, and validation (CQV) with a validation lifecycle management system streamlines processes, enhances compliance, and mitigates risks. Learn more here.