INSIGHTS ON CONTRACT PHARMA MANUFACTURING
Transitioning From Academic Research To Drug Formulation And Development
The transition from academic research and studies to industry research demands that individuals master additional skills, sets different objectives, and defines “success” differently.
Advancing Aseptic Filling: Evaluating The Revolutionary SA25 Workcell
Examine how leveraging a fully robotic aseptic filling system enables versatility, high yields, and low losses, as well as precise and repeatable fill parameters batch to batch.
Opportunities To Accelerate Allogeneic Cell Therapy
Learn more about the potential of allogeneic cell therapies to combine the efficacy of personalized medicine with the scalability, accessibility, and uniformity of traditional off-the-shelf therapeutics.
Nitrosamine Impurities Deadline: Are Your Products Compliant?
The FDA nitrosamine contamination guidance set deadlines of Nov. 1, 2023, for risk assessment updates and Aug. 1, 2025, for full NDSRI limit compliance.
The Role Of The Technical Transfer Executive Sponsor
Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.
The Fundamental Outsourcing Question All Sponsors Face
To end our Outsourced Pharma Live event on strategies for quality and regulatory outsourcing challenges, Chief Editor Louis Garguilo emphasizes the crucial question to ask when selecting a CDMO.
How To Connect Quality And Regulatory “At The Hip”
Our Outsourced Pharma Live panel of experts introduce challenges and strategies to ensure your internal – and external partners’ – quality and regulatory professionals work together.
File First In Europe, Then The U.S.?
Karla Knower, Global Head of Regulatory Affairs, Paradigm Biopharmaceuticals, answers a challenging question from an attendee at a recent Outsourced Pharma Live.
The Nature Of Quality Management Needs To Change
In these 3 minutes, Bikash Chatterjee, an Outsourced Pharma Board Member, discusses how the current drug development and manufacturing landscape necessitates different approaches for quality teams.
The Wrong Way For Your CDMO To Upgrade Facilities
Christine Feaster, who has worked for top 50 pharma and start-up organizations, relates a case study as a warning to sponsors when CDMOs look to upgrade facilities and add capabilities.