Exclusive Pharma Microbiology interview with Maria Jose Lopez Barragan, formerly at FDA
SMi Reports: An exclusive interview with María José López Barragán, Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, who will be speaking at the 3rd Annual Pharmaceutical Microbiology East Coast Conference released.
The Pharmaceutical Microbiology Conference East Coast Virtual Conference will be commencing on 28th and 29th October 2020 and will focus on technological developments that push innovation and tackle the most pressing challenges in the world of pharmaceutical microbiology.
SMi caught up with María José López Barragán, Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, who will be presenting a keynote address at the conference.
María José (Pepa) Lopez Barragán is a former U.S. FDA regulator and founder of Barragan BioConsulting, where she offers Regulatory and Compliance consulting services to pharmaceutical companies globally. Pepa has 15 years of combined experience in Regulatory Affairs (CMC) and multiple aspects of drug development and research and has participated in the approval of 15 original and biosimilar biologic license applications, focusing on microbiology product quality and sterility assurance aspects.
Here is a snapshot of what was discussed:
The pharmaceutical microbiology market has matured greatly over recent years, what significant developments have you noticed in the last year within the field?
The use of robotics and automation continues to take over the pharmaceutical industry with a fast-increasing utilization of single-use systems (SUS). The combination of automation and single-use equipment (including even disposable ultrafiltration/diafiltration systems) has contributed to a higher level of microbiology control and have represented a new paradigm for the biopharmaceutical industry. However, this new paradigm was not free of challenges such as restricted production batch size, systems handling and testing to assure integrity throughout the manufacture and storage of products, need for enhanced suppliers quality agreements, higher risk for extractables and leachables into the product, and a long etc.
What current hot topic will you be addressing in your presentation and how it makes it relevant to 2020?
During my presentation, I will discuss about humans as ecosystems and how they pose a source of contamination risk during the manufacture of biopharmaceuticals. My presentation will also address the types, material and use of garment in cleanrooms. This topic may be considered of major interest in our present times due to the COVID-19 pandemic, which has created worldwide awareness of how the adequate use of specific garments can control the spread of microbes.
The full interview can be downloaded at: www.pharma-microbiology.com/PR9
Interested in joining the conference and workshop you can register your place for only US$499 (conference) and US$299 (workshop) www.microbiologyeastcoast.com/PR9
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SMi’s 3rd Annual Pharmaceutical Microbiology East Coast
Virtual Conference: Online Access Only
Conference: October 28th-29th, 2020
Workshop: October 30th, 2020
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