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By Gregory MacMichael, Ph.D., president, CMC Bioservices LLC
Biologics development and manufacturing platforms should fit their target product profile. Here are four considerations for building more efficient platforms as part of overarching strategies to shorten path-to-market timelines while protecting quality and safety.
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Having covered what a clinical hold is and the disruption they cause, Umoja Biopharma VP of regulatory affairs, Helen Kim, and NDA Partners regulatory affairs expert consultant, Daniela Drago, Ph.D., dig into how biopharmas can avoid them from the outset in this segment of the Bioprocess Online Live event “IND Success: Navigate Through The Regulatory Gray.”
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White Paper
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By Josh Hoops,
CAI
Read more about what a facility needs to achieve operational readiness and the necessary steps to take to be at full-scale production when the “go” button is hit.
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Article
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By Paul Priebe,
Qosina Corporation
Mechanical hose barb connections look deceptively simple, but the process of bringing all three elements together to meet application requirements must be controlled based on risk assessment.
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Webinar
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ILC Dover
This webinar covers a well-designed, single-use flexible enclosure system that delivers equivalent, if not better, containment performance than a hard-shell isolator, at a fraction of the cost.
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Article
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By Ahmed Besheer,
Lonza
As the field of biologics increases its focus on identifying new diseases to target and novel constructs to treat them, innovative administration devices are once again in the spotlight.
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Case Study
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By Daniel L. Kirschner, Ph.D., and Tom Lovelace,
Cambrex
With a complete picture of the parameters that control each step during manufacturing, chemists can monitor and control individual reactions to optimize the overall production process.
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Application Note
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Daniel Tischler,
Single Use Support
Learn about hybrid solutions for drug freezing and thawing, control over freezing and thawing of bottles, and how single-use bags support the start of a change in bioprocessing technology.
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Article
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By Evan Zynda and Aditi Singh,
Thermo Fisher Scientific Bioproduction
Learn more about how allogeneic approaches have the power to revolutionize the use of CAR T-cell therapies.
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Article
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By Alla Zilberman,
Cygnus Technologies Inc.
Read how host cell proteins can constitute a significant component of a biopharmaceutical drug developer’s overall risk-management strategy.
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Article
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By Martin Gonzalez, Ph.D.,
Pfizer CentreOne
Explore some of the most relevant engineering activities that are necessary to successfully transfer a product from vial into a prefilled syringe presentation.
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e-book
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Rockwell Automation
Learn how advances in modern manufacturing execution systems can help you optimize production, speed time-to-market, and ease compliance.
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Application Note
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Pall Corporation
Discover a digital transformation solution that provides first-of-its-kind data analytics for filter integrity testing. The software helps operators and supervisors reduce time lost through review processes.
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Article
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IDBS UK HQ
Learn more about a significant area of opportunity for improvement when addressing the inefficiencies in manual record keeping and data management.
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Article
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Cytiva
Purespring Therapeutics explores the importance of pursuing new treatments for kidney conditions and shares why it's poised for long-range commercial success.
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West Pharmaceutical Services, Inc.
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Yourway, The Biopharma Services Company
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Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.
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