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04.08.21 -- Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021

04.08.21 Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021

On this episode of the
Business of Biotech, Nevan Charles Elam, J.D., founder of Rezolute Bio, shares the company s rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses the company s approach to process development and manufacturing. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Philip Chen, Kayleigh McGlynn, and Jenny Shmuel, Fish & Richardson P.C.
This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020, transition date, as well as the FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic. ....

Niklas Sandler , Samsung Biologics , Satu Lakio , Oliver Stauffer , Josh Russell , Lee Allen , Fred Hines , Patrick Guertin , Megan Mason , Abdelaziz Toumi , Megan Kuikstra , Brad Larson , Lonza Biologics , Samuel Chia , Jim Springer , Steve Halpin , Jones Healthcare Group Packaging Services , Article Ajinomoto Bio Pharma Services , Automated Systems Of Tacoma Inc , Health Canada , Pharmaceutics International , Automated Systems , Professor Niklas Sandler , Richard Tree , Vlad Spehar , Jones Healthcare Group Packaging ,

04.01.21 -- Auditing Electronic Batch Records For cGMP Status

04.01.21 Auditing Electronic Batch Records For cGMP Status

Sponsor
Pharmaceutical Online and Techceuticals, in collaboration with Federal Equipment Company, are excited to announce Virtual Pharma Expo: Oral Solid Dose Manufacturing. Don’t miss this FREE LIVE event on May 5th & 6th featuring 15-minute presentations with leading OSD packaging and process equipment manufacturers. Register Now.
Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
This article presents some advice for auditing electronic batch records to assess their cGMP status. This is useful in the qualification stage and essential once the electronic record system is in operation.
Industry Insights
Article ....

Comunidad Autonoma De Cataluna , Paul Magreta , Majaz Hussain , Brian Stephens , Mukta Acharya , Jessica Settimi , Quadro Comil , Case Study Seeq Corporation , Case Study Flow Sciences Inc , Equipment Company , Article Promega Corporation , Application Note Silverson Machines Inc , Samira Shore , Thermo Fisher , John Barley , Grifols Recombinant Protein , David Winger , Federal Equipment , Maurizio Della Pietra , Particle Measuring , Brandy Sargent , Lonza Pharma , Silverson Machines , Flow Sciences , காமுனிடட தன்னாட்சி டி கடலுள் , அஜாஸ் ஹுசைன் ,

03.16.21 -- 11 Critical Steps To Manage Solvents During API Manufacturing

03.16.21 11 Critical Steps To Manage Solvents During API Manufacturing

Gibco premium peptones are specifically created for bioprocessing to achieve a higher level of quality and limited variability. The result can improve performance and speed-to-market for your next monoclonal antibody (mAb) blockbuster. Considering peptones but unsure where to start? Learn about smaller-sized Starter Paks the easiest way to assess the variety of peptones offered and to identify the ideal supplements for your process.
Featured Editorial
By Grant Mordue, Pro-Active GMP Consulting Ltd.
To reduce costs and provide flexibility, manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of APIs and associated intermediates. This article explores the risks and 11 mitigation options available to API manufacturers. ....

Sandra Conway , Oliver Stauffer , Jeff Morrow , Mark Santos , Peter Walton , Derek Pendlebury , Bruce Mccafferty , Daniel Carpenito , Jonathanm Glynn , Bobby Sheng , Jones Healthcare Group Packaging Services , Case Study Seeq Corporation , Bora Pharmaceuticals , Case Study West Pharmaceutical Services Inc , Pfizer Centreone Contract , Jones Healthcare Group Packaging , Jeff Morrow Lucas , Pfizer Centreone , Thermo Fisher , Particle Measuring , Anton Paar United , West Pharmaceutical Services , Thermo Fisher Scientific , சாண்ட்ரா கான்வே , ஆலிவர் ஸ்டாஃபர் , ஜெஃப் நாளை மறுநாள் ,

03.04.21 -- FDA Steps Up Support For Advanced Manufacturing Technologies

03.04.21 -- FDA Steps Up Support For Advanced Manufacturing Technologies
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.

Niklas Sandler , Iwan Roberts , Satu Lakio , Mark Cappucci , Chris Gilmor , Bernt Dietmar Schober , Andrea Franks , Emmanuel Ligner , Cmos Cmdos , Jeff Phillips , Apis Hpapis , James Klingelhoefer , Frank Panofen , Andreas Stolle , Jones Healthcare Group Packaging Services , Alconox Inc , Qa Evonik Corporation , Case Study Pfeiffer Vacuum Inc , Webinar Dec Group , Thermo Fisher , Jones Healthcare Group Packaging , Particle Measuring , Professor Niklas Sandler , Pfizer Centreone Contract , Pfeiffer Vacuum , ஆண்ட்ரியா பிராங்குகள் ,

02.25.21 -- Developing Future Delivery Models For ATMPs

02.25.21 Developing Future Delivery Models For ATMPs

Seeq is hosting a live virtual event featuring pharmaceuticals and life sciences experts from Eli Lilly, Lonza, Amgen, and more on March 10, 2021. Mark your calendars and register to hear how other companies in your industry are using advanced analytics technology to turn their data into insights, drive process improvement, and increase profitability.

This is a live event, and the presentations will not be accessible afterward. Save your spot today spaces are limited!
Featured Editorial
By Erich H. Bozenhardt and Herman F. Bozenhardt
With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial ma ....

Paola Lazzeri , Anna Campanella , Samsung Biologics , Giulia Artalli , Robin Bogner , Frank Panofen , Dennis Seibert , Mike Coyne , Kevin Lawler , Timothy Aschl , Yongho Ahn , Matthew Olsen , Martin Gonzalez , Alok Tayi , John Gill , Daniele Pandolfi , White Paper Alconox Inc , Pfeiffer Vacuum Inc , Pharma Services , Equipment Company , Application Note Silverson Machines Inc , University Of Connecticut , Pfizer Centreone Contract , Anton Paar United , Sartorius Stedim , Maurizio Della Pietra ,