Industry Insights
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A Brief Overview Of Vaccine Purification Technologies And Analytical Tools
3/23/2023
Downstream processing remains a major bottleneck for vaccine production, and the industry is racing to develop new purification technologies. Here's a snapshot of where we stand and of what needs to happen next to increase quality and yields.
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The Formulation Development Journey
Successful formulation journeys start with a roadmap where scientific studies and decision points create a route for understanding a molecule’s personality and its viability to help it along the way to the patients.
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5 Qualifying Questions To Evaluate Solution Providers For Temperature-Controlled Shipping
1/3/2019
Life sciences companies with complex warehousing and shipping requirements have a lot of questions. Here are the questions to ask to identify a logistics vendor with the right competency.
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Referencing A Listed Drug For The 505(b)(2) Pathway
8/27/2021
Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) new drug application (NDA) as an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.
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What Is The Best Way To Keep Up With Changes In FDA Standards?
This is an interesting concept, one that actually goes by the name of “Regulatory Intelligence.” Regulatory Intelligence (RI) is something that's really important because the standards are always evolving. In the United States, for example, they start at the top with the Federal Food Drug & Cosmetic Act, and recently, the Drug Quality and Security Act of 2013. FDA takes these laws and promulgates regulations and guidance documents to interpret those regulations.
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FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug & Biological Products
1/19/2022
The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and real-world evidence (RWE) into clinical research, product approvals, and post-approval monitoring of drugs. You can submit public comments until March 3, 2022.
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Challenges And Innovation In Gene Therapy Manufacturing
8/8/2022
The road to final approval for a biotherapeutic is long and filled with obstacles, from manufacturing and scale-up to regulatory adherence and business practices.
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Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance
11/29/2017
A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.
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Comparing Analytical Approaches For AAV Characterization
3/28/2024
Explore evidence that mass photometry is a favorable method due to its accuracy, versatility, and low time, sample, and expertise requirements.
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The Future Of Influenza Vaccines: Self-Amplifying mRNA
2/4/2022
As we recognize National Immunization Awareness Month, valued contributor Roberta Duncan of Seqirus looks to the future of vaccine development and the priority that mRNA has become in vaccine research programs. Among other benefits, she says the tech can be moved into clinical trials more rapidly than other platforms.