Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date New-Drug Development: Succeeding With the FDA Premier Consulting - Kristi Miller, Ph.D., Senior Vice President, Regulatory Affairs Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the s... 1 year ago | 47 mins FINDING THE COMMON ROAD TO QUALITY FOR SINGLE-USE MATERIALS Dr Trishna Ray-Chaudhuri, Genentech & Dr Hélène Pora of Pall Biotech | – GMP requirements touch every single use assembly used in clinical studies to commercial manufacturing. The drug product produced in clinical studie... 5 years ago | 64 mins New Paradigm of Building Quality during Manufacture - Challenges with Biologics Dr Rajesh K. Gupta Historically, quality of biological products has been ensured through testing representative samples. Shift in quality paradigm started with implement... 6 years ago | 75 mins New-Drug Development: Succeeding With the FDA Premier Consulting - Kristi Miller, Ph.D., Senior Vice President, Regulatory Affairs Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the s... 1 year ago | 43 mins Corning®バイオプロセスの最新培養技術とシングルユース技術導入ポイントセミナー コーニングインターナショナル株式会社 ライサイエンス事業部 石渡 孝至 バイオロジクスの大量培養を具現化に向け、幹細胞、癌細胞、タンパク発現系細胞の基礎的培養技術を示しながら、弊社のシングルユース品質規格（ISO / GMP / QMS）について概説します。 ＜セミナーのポイント＞ 細胞治療・遺伝子治療を中心にバイオプロセス開発が急速に進められております。幹細胞、癌細... 4 years ago | 60 mins Challenges and Processes for Development and Scale-up of Stem Cell Therapies Carolyn Wrightson, Ph.D., VetStem Biopharma and Austin Mogen, Ph.D., Corning Incorporated GMP cell manufacturing for new clinical cell therapies is a rapidly expanding need in the life science space. This presentation will discuss the found... 2 years ago | 62 mins Bringing Gene Therapies to Life: Navigating Scale Up, Partnerships, and Barriers Ben Josey Ph.D., Field Application Scientist, Corning Life Sciences Cell and gene therapies are rapidly advancing and with that, the need to effectively generate large volumes of viable cell and gene therapy products t... 10 months ago | 29 mins New-Drug Development: Succeeding With the FDA Premier Research Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the s... 6 months ago | 43 mins
