Tim Wright

3 weeks ago | contractpharma.com | Tim Wright

Welcome to the April issue of Contract Pharma. This month’s edition highlights critical trends and challenges shaping the pharma manufacturing and development landscape, highlighting new regulatory requirements, advances in therapies, and shifts in manufacturing strategies. First, the pharmaceutical industry’s reliance on analytical testing has grown substantially, driven by increasing regulatory demands and the need for improved quality assurance.

3 weeks ago | contractpharma.com | Tim Wright

The life sciences industry operates under immense pressure to maintain product quality, meet strict regulatory standards and optimize efficiency. At the same time, many manufacturers struggle with outdated systems and processes that exacerbate bottlenecks, slow down production and increase the risk of noncompliance.

3 weeks ago | contractpharma.com | Tim Wright

Formulation optimization during the scale-up process from preclinical through early phase clinical trials is crucial for maintaining control over dissolution rates, which directly impact the bioavailability and therapeutic efficacy of drug products. As drug candidates transition from the research lab to larger-scale production, managing factors such as particle size and formulation composition becomes essential to uphold the integrity and performance of the drug.

3 weeks ago | contractpharma.com | Tim Wright

Obesity and type 2 diabetes are not only widespread, they are also partly interrelated. People suffering from obesity have an increased risk of developing type 2 diabetes. According to estimates by the International Diabetes Federation, 540 million people worldwide are currently living with diabetes, more than 90 percent of whom have type 2.

3 weeks ago | contractpharma.com | Tim Wright

Testing for the presence of nitrosamines on pharmaceutical drug products will be a requirement on all prescription drugs, over-the-counter (OTC) drugs, and drug products in clinical development starting on August 1, 2025. This mandate ensures compliance with regulations from the U.S. Food and Drug Administration (FDA) as well as other global regulatory agencies.1,2 At the time of publication, organizations have less than four months remaining to comply with the new regulations.