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Why Lactococcus Lactis Might Be The Best Membrane Protein Factory
11/17/2023
The bacteria lactococcus lactis has emerged as a promising alternative expression system for membrane proteins, which are difficult to manufacture. L. Lactis is inexpensive and easy to grow. It also doesn't produce endotoxins, which makes it a good fit for therapeutic applications.
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Liquid Biopsy: The Next Evolution In Personalized Prostate Cancer Screening
11/7/2023
The prostate-specific antigen (PSA) blood test has long been the gold standard in prostate cancer diagnostics. More recently, liquid biopsy, which includes the analysis of circulating tumor material in the blood or urine, has emerged as a promising non-invasive tool.
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FDA’s Proposed Laboratory-Developed Tests Rule Raises Many Questions But Provides Few Answers
10/11/2023
The FDA has issued a new proposed rule on laboratory-developed tests (LDTs), expressly defining LDTs as a type of in vitro diagnostic (IVD) device, and subject to device regulations, including registration and listing, premarket review, and more. The FDA is accepting comments on the proposed rule through December 4.
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Using Automation For Antimicrobial Screening
10/5/2023
A major challenge with antimicrobial drug development is the necessity to test millions of drug compounds in the hope of finding one that will kill a given microbial pathogen. Laboratories are using robotic machines and automated solutions to try growing previously unculturable organisms that might be sources of antimicrobial compounds — and these efforts are finding success.
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Preformulation Of Excipients In Biologics Development
9/28/2023
Most of the instability problems of a drug product come from excipients, in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatability.
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FDA Introduces Quality Management Maturity Program
9/26/2023
The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.
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New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters
9/11/2023
The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.
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From Chips To Genes: The New Era Of Animal Models Transforming Drug Testing And Research
8/16/2023
The U.S. is at the forefront of the AI-based research trend surge to elevate the understanding of human physiology, testing potential therapies, and identifying disease mechanisms. Let's examine the five most promising innovative advancements in animal models, as well as key considerations for those working in the field.
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CGMP Requirements For Automated Facility Monitoring Systems
8/15/2023
To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.
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Mechanistic Modeling To Optimize rAAV Production For Gene Therapy
8/11/2023
Current processes in recombinant adeno-associated virus (rAAV)-based gene therapy production are generally not readily scalable. A group of scientists and engineers at MIT collaborated with the team at UMass Chan Medical School to develop a mechanistic model for the intracellular phenomena occurring during baculovirus infection and rAAV virion production in insect cells. A free and user-friendly implementation of the model is available online, and you can use it to test a wide range of conditions and hypotheses.