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08.17.21 -- 10 Critical Validation Parameters For Microbiological Experiments

08.17.21 -- 10 Critical Validation Parameters For Microbiological Experiments
pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.

Dominic Hyde , Paul Magreta , Megan Mason , Harry Benson , Webinar Samsung Biologics , Hunter Malanson , Rose Pham , Peter Poechlauer , Eleonora Bellissimi , Lee Allen , Matthew Jones , Herb Crosby , Thermo Fisher , Ken Ball , Hue Rose Pham , ஆதிக்கம் செலுத்தும் ஹைட் , மேகன் கொத்தனார் , ஹாரி பென்சன் , உயர்ந்தது ஃப்யாம் , லீ ஆலன் , மேத்யூ ஜோன்ஸ் , மூலிகை கிராஸ்பி , தெர்மோ மீனவர் , கேன் பந்து , சாயல் உயர்ந்தது ஃப்யாம் ,

01.21.21 -- Using Production And Postmarket Data To Validate FMEA Assumptions

01.21.21 Using Production And Postmarket Data To Validate FMEA Assumptions

Acepodia s Dr. Sony Hsiao, CEO, and Dr. Mark Gilbert, SVP of R&D, join
Business of Biotech for a discussion on the company s approach to dramatically reducing the cost of cell therapy development, manufacturing, and administration via its oNK, CAR, and ACC candidates. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Mark Durivage, Quality Systems Compliance LLC
One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and post-market surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings. ....

Paul Magreta , Sheri Gimigliano , Beth Kendserky , Dan Updyke , Spencer Bolte , James Faust , Albert Cheong , Mariana Curcio , Allison Alix , Eleonora Bellissimi , Gillian Miller , Rose Pham , Hunter Malanson , Timothy Wortley , Patrickm Hutchins , Scott Martin , John Erdner , Debra Barnes , Frederic Baudry , Jeff Sizemore , Seption Group , Article Stevanato Group , Rockwell Automation , Automated Systems Of Tacoma Inc , Pharma Services , Application Note Silverson Machines Inc ,

Upstream Considerations For Biosimilar Development

Upstream Considerations For Biosimilar Development
By Hunter Malanson, Staff Scientist, Field Applications; Mariana Curcio, Technical Sales Specialist; and Albert Cheong, Associate Director, Services & Product Application, Thermo Fisher Scientific Bioproduction Cell Culture
Many of the early and costly steps of drug development can be eliminated with biosimilars, which offer several advantages to pharmaceutical companies exploring new strategies for increasing their presence in the market. However, essential information regarding aspects of process control, such as upstream control parameters, may be unknown about the innovator drug, resulting in challenges during biosimilar development. Understanding these challenges and creating a strategy to overcome them is critical for ensuring a high chance of success with your biosimilar product. ....

Hunter Malanson , Mariana Curcio , Albert Cheong , Services Product Application , Staff Scientist , Field Applications , Technical Sales Specialist , Associate Director , Product Application , Thermo Fisher Scientific Bioproduction Cell , மரியானா கூர்ஸிோ , ஆல்பர்ட் சியோங் , சேவைகள் ப்ராடக்ட் விண்ணப்பம் , ஊழியர்கள் விஞ்ஞானி , புலம் பயன்பாடுகள் , தொழில்நுட்ப விற்பனை நிபுணர் , இணை இயக்குனர் , ப்ராடக்ட் விண்ணப்பம் ,