Exceeding Your Benchmark

Pharmaceutical manufacturers are under increasing pressure to deliver sterile, high-quality medicines in smaller batches and faster cycles. As pharma manufacturing evolves evolves, regulatory demands have intensified especially following the 2023 revision of EU GMP Annex I, which places new emphasis on contamination control strategies, improved traceability, and minimizing human intervention throu...

In this episode of Exceeding Your Benchmark, host Michelle Dawn Mooney speaks with Abby Roth, founder of Pure Microbiology, about sterile compounding and contamination control. Abby shares her expertise in microbiology, sterile environments, and best practices in pharmaceutical compounding. The conversation begins with a distinction between traditional drug manufacturing and sterile compounding, h...

In the rapidly evolving domain of life science manufacturing, validation emerges as a cornerstone to ensure that products meet stipulated requirements concerning quality, safety, and efficacy. This pivotal aspect of manufacturing comes to focus as regulatory landscapes shift, mandating stringent compliance to ensure patient safety. In a recent episode of Exceeding Your Benchmark , a podcast by Ben...

Fred Ayers at pharmaceutical manufacturer Eli Lilly discusses the trends in contamination control and regulations surrounding this.

Contamination control is absolutely critical in the pharmaceutical industry and includes particulate, microbial, product carryover, chemical, and viral aspects of contamination and often involves proactive, reactive, and supporting aspects. However, regulations, liabilities, and patient health added to the mix create data silos that often form multiple processes and make it difficult to create eff...

Pharmaceutical companies invest significant resources in research and development to discover new drugs and therapies and improve existing ones. This involves rigorous testing, clinical trials, and obtaining regulatory approval before a drug can be sold. Government agencies, such as the Food and Drug Administration (FDA) in the United States, oversee the approval process and conduct regular inspec...

In this podcast episode of "Exceeding Your Benchmark," host Gabrielle is joined by Ashley Harp, Lead Process Engineer at CRB. They discuss the challenges life science companies are facing as they adapt to new technologies and advancements in manufacturing, specifically in the area of combining highly potent active pharmaceutical ingredients (HPAPIs) and monoclonal antibodies into antibody drug con...

Between 2022 and 2030, the cell and gene therapy sector is expected to experience a compound annual growth rate (CAGR) of 39.42 percent, BioSpace said of a recent Vision Research Report. This is quite a large anticipated growth; how will startups and current manufacturing companies work to meet this growing demand? On today’s episode of Exceeding Your Benchmark, Guest Sumit Verma, Senior Vice Pres...

Over the summer new GMP Annex 1 regulations were released by the FDA and EMA, prompting new changes to become standard protocolin sterile manufacturing companies. By August 2023, the regulations will take effect and companies will have to ensure that they are in compliance with the guidelines set. Discussing this on a new podcast, host Gabrielle Bejarano talked to Chris White, who is the Global He...