Industry Insights
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Asian Companies Leverage MES At Manufacturing Facilities
2/24/2025
Asian pharma manufacturers are constantly under pressure to produce high quality products on time. Explore how Asian pharmaceutical companies are leveraging MES to enhance efficiency and compliance.
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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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Supporting AAV And Lentiviral Vector Development And Commercialization
1/12/2021
Plasmids are essential for the development of viral vectors used to manufacture novel gene therapies and viral vaccines. We are supporting the innovation of drug developers in this space by providing standardized royalty-free, bulk AAV helper and lentiviral packaging plasmids for research and GMP production.
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Effective Separation Of Full And Empty AAV Capsids By Anion Exchange
We show how Capto Q resin with dextran surface extenders, magnesium chloride (MgCl2), and the elution salt type (especially for rAAV9) significantly enhance separation.
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Equipment Validation In The Pharmaceutical Industry
12/17/2024
Equipment validation ensures pharmaceutical equipment meets regulatory and quality standards. Explore how a structured process ensures compliance, reliability, and high product quality.
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Understanding And Navigating Diverse Regulatory Environments
2/21/2024
Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.
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Revolutionizing Drug Manufacturing: A Closer Look At GMP Inspections
12/20/2023
Learn about the collaborative efforts among global regulators currently underway to address drug availability challenges following the supply shortages and disruptions from the COVID-19 pandemic.
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5 Biggest Trends Of Oligonucleotide Manufacturing In 2022
2/18/2022
The rapidly growing market for Oligonucleotide manufacturing represents an opportunity for investors and pharma companies that wish to produce novel pharmaceutical products and therapies.
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Monoclonal Antibody Development For Commercial Success
11/29/2022
With roughly 90% of all drugs failing to make it through clinical trials, see why it is crucial to accelerate the first step of getting to the clinic with a new mAb candidate.
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Quality Without Compromise: GMP Annex 1 For Sterile Manufacturing
2/4/2025
Annex 1 sets EU regulatory standards for sterile manufacturing, which emphasize contamination control, quality management, and risk prevention to enhance patient safety and regulatory compliance globally.