Industry Insights
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Strategic Partnership Delivers Innovation, Efficiency In Biotech Training
6/9/2020
While manufacturing training typically takes years, a Cytovance Biologics methodology developed in partnership with academia resulted in a fully-functional biotech floor team in under 3 months.
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6 Tips For Successful Drug Discovery Teamwork
12/16/2022
While people don’t always think about the choreography of good scientific teamwork, there are factors that should be considered and skills that can be developed to increase a drug discovery team’s overall effectiveness and chance of success.
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3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma
4/25/2022
Outsourcing and technology have morphed our industry into a new decentralized model. Now, each sponsor must carefully develop an ongoing compliance strategy considering its unique business model and its influence on the drug development journey. Strategies are needed to design QMS' that can expand and pivot in tandem with corporate and clinical development.
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Nanoparticle Engineering: Revolutionizing Oral Drug Delivery
Nanoparticle engineering has emerged as a promising solution for enhancing drug solubility and bioavailability and improving efficiency within the drug development pipeline.
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What Is A P&ID And How Can I Use It To Understand My Bioreactor Better?
11/14/2023
Learn how to interpret a P&ID in order to understand the functionalities of your bioreactor and its capabilities.
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Harmonious Harmonization: How To Get Quality System Alignment Right
4/8/2020
This article is the second in a two-part series explaining how to successfully harmonize disparate quality systems when two companies combine. Part 1 shared horror stories — drawn from the author’s experiences — illustrating what NOT to do during each phase of QMS harmonization. Here in Part 2, we look at case studies in which companies got it right, bringing together parallel quality systems in a way that increased the probability of success.
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21 CFR Part 11: 7 Ways To Avoid Noncompliance
12/20/2022
Explore the elements critical to 21 CFR Part 11 compliance, how they relate to noncompliance risks, and how a QMS software solution for life sciences simplifies the compliance process.
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Expedite Commercial Launch Readiness For ADC Manufacturing
An effective strategy will reduce the probability of late-stage process, analytical, or manufacturing site changes which could put chemistry, manufacturing and controls (CMC) activities on the critical path.
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Modularity And Mobility Hold The Keys To Surge Manufacturing
11/30/2022
When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.
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Rare Diseases And Intellectual Property: Creative IP Strategies
7/15/2015
In recent years, medical research and drug development have transformed the outlook of countless people living with diseases that were formerly untreatable. Desire for tenable treatments and cures, however, is not sufficient to prompt the ongoing development of new therapies. Policymakers now face a challenge: to create and maintain a climate that fosters innovations in health while providing widespread access and meeting therapeutic needs.