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1. Unpacking Pfizer's Advanced Process Control Platform For Upstream Ops 8/29/2025

   Pfizer's advanced process control platform gives modelers more dexterity compared to default controllers, thus speeding up process development.

2. Weight Of Evidence Assessments For Carcinogenicity Studies: An Overview 8/20/2025

   Carcinogenicity assessments often rely heavily on two-year rodent bioassays. The weight of evidence (WoE) approach seeks to streamline this process, combining thorough science with regulatory practicality.

3. Report: Nearly 40% Of Biomanufacturers Eyeing Continuous Processing 8/19/2025

   Continuous perfusion manufacturing came about before the technology was mature enough to support it. Now, new data suggests an inflection point in the status quo.

4. The Building Blocks Of A Robust Analytical Assay 8/1/2025

   Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

5. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

   In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

6. Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet 6/19/2025

   This scientific article presents a summary of the formulation development strategy of a JAK1 inhibitor extended-release tablet, with a focus on experimental design, data interpretation, and formulation decision-making.

7. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

8. AI's Potential To Aid Multispecific Analytical Characterization 5/16/2025

   Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.

    

9. Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis 5/6/2025

   Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.

10. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.