On this unique Drug Digest video interview, Felicity Thomas, Affiliate Editorial Director, and Feliza Mirasol, Science Editor, Pharmaceutical Know-how Group, interview consultants about aseptic processing and manufacturing. Throughout the dialogue, business consultants will consider the significance of aseptic processing and manufacturing, highlighting the challenges impacting business, the intricacies of the regulatory panorama, the significance of understanding nuances between merchandise and processes, the need of addressing QC/QA early on, greatest practices to make sure aseptic sterility, and potential future tendencies.
Interviews that includes
Maik W. Jornitz, Founder and Principal Marketing consultant, BioProcess Sources
Maik W. Jornitz, founder and principal advisor of BioProcess Sources, is a 35-year veteran of the business. He’s extremely skilled in single-use bioprocesses, aseptic processing, and a subject professional in sterilizing-grade filtration and filter integrity testing. He has printed a number of books, e-book chapters and over 100 scientific papers on numerous bioprocessing and facility design matters. He’s the previous chair of the Parenteral Drug Affiliation (PDA) board of administrators and science advisory board, and member of a number of PDA Job Forces, together with the European Union Annex I response group. He’s board member and senior enterprise and technique advisor of DIANT Pharma. As a college member of varied coaching actions, together with PDA Coaching and Analysis Institute, he trains members of the business and regulatory authorities regularly. In his earlier roles, he was the CEO of G-CON for 10 years, he labored 26 years for Sartorius, along with his final function being the senior vice-president for International Product and Advertising Administration Bioprocess. He obtained his Grasp of Engineering in Bioengineering on the College of Utilized Sciences in Hamburg, Germany, and completed the Program for Government Growth at IMD Enterprise College in Lausanne, Switzerland.
Dan Unusual, PhD, Chief Know-how Officer, Mobile Origins
Dan Unusual has been working on the intersection of engineering and biology for nearly 15 years, and he’s an inventor on 20 patents. After finishing a PhD in regenerative drugs on the College of Cambridge, he moved to TTP the place he developed advanced drug supply units. He was instrumental within the creation of a number of expertise platforms efficiently licensed to giant pharma in offers price over $100 million. For the previous 4 years, Unusual has targeted on cell remedy manufacturing gear. Unusual is an lively member of varied automation working teams and was a reviewer on the Alliance for Regenerative Medicines A-Cell report on cell remedy manufacturing.
Sponsors
This episode of Drug Digest is sponsored by:
- Kindeva Drug Supply
- Veltek Associates
About Drug Digest
Drug Digest is a tech speak video collection with the Pharmaceutical Know-how® editors, who interview business consultants to debate the rising alternatives, obstacles, and advances within the pharmaceutical and biopharmaceutical business for the analysis, improvement, formulation, evaluation, upstream and downstream processing, manufacturing, provide chain, and packaging of drug merchandise.
Upcoming episodes
- September 2024: Small Molecule APIs, Excipients, and Formulation
- October 2024: Automating Course of Growth
- November 2024: Stable Dosage Drug Growth and Manufacturing