Newsletter | April 18, 2025

04.18.25 -- Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making

SPONSOR

Enhance Bioprocess Sampling With MAST® Autosampling Solution

Looking to reduce contamination risk, increase measurement frequency and save time and resources? Automate your bioprocess sample collection! With an automated sampling system, samples can be pulled from the process stream and sent to different analyzers to obtain data without the need for operator intervention. This can replace both at-line and off-line sample analysis. Discover now how to enhance bioprocess sampling with MAST® Autosampling Solution!

FOCUS ON REGULATORY

Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making

The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.

Biological Indicators - Population Assay

Watch this discussion to learn about resistance testing and using it to control and monitor incoming biological indicators (BI).

Utilize Modular Cleanrooms To Reduce Your Risk Of A Form 483 Violation

Maintaining a cleanroom facility that remains safe for your workers – and where the therapeutics they produce remain safe for patients – can ease your compliance concerns.

Compressed Gas Contamination: Guidelines For Control

Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.

REGULATORY SOLUTIONS

Cleanroom Classification Zone Creation - TSI Incorporated

SPONSOR

The debate rages on. While the automation that enables continuous processing gets a lot of hype, there are plenty of dyed-in-the-wool biopharma pros who contend that process optimization and intensification yield comparable benefits, without requiring the capital-intensive process overhaul that continuous demands. Join Bioprocess Online Live for a virtual deep dive into the scalability, sustainability, and capital implications of the continuous-versus-optimized debate. Registration is free thanks to the support of Cytiva.

FOCUS ON QUALITY/ANALYTICAL METHODS

Assessing A Targeted Molecular Method For Adventitious Virus Detection

Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

Using Novel Biological Responses For Robust Cell-Based Potency Assays

Ensure the potency and efficacy of your biologic products with Catalent's GMP-compliant potency bioassay, offering accurate real-time assessments for GMP release and stability testing.

Top 8 Benefits Of Mass Spectrometry Imaging Early In Drug Development

Here we explore the top 8 benefits of using mass spectrometry imaging in the oncology drug discovery and early development stages.

Why DSC Testing Is A Critical Step In Developing Biosimilar Drugs

Explore the importance of testing in the regulatory process and how tools like Differential Scanning Calorimetry (DSC) are helping to bring more biosimilars to patients in need.

High-Sensitivity IVT mRNA Analysis

Quality analysis of in vitro transcribed (IVT) has become an essential part of biotherapeutic workflows. Discover a high-sensitivity kit made for analyzing IVT mRNA quality to advance your research.

nanoDSF As An Efficient, High-Throughput Method For ID Testing

Unlock efficient, high-throughput biologics ID testing with a label-free method that analyzes protein stability via thermal unfolding, creating unique fingerprints for rapid quality control.

Flow Cytometry Panel Design Fundamentals

Multicolor flow cytometry is a powerful technology that enables simultaneous analysis of multiple markers at the single-cell level. Read on to explore the flow cytometry panel design journey.

Navigating The Analytical Complexity Of Oligonucleotide Therapeutics

From identity and purity testing using chromatography and electrophoresis to PCR and microbial studies, explore advanced analytical solutions tailored for siRNA, miRNA, pDNA, and mRNA products.

The LabZient Analytical Platform: Q&A With Eric Miller

Discover how our LabZient™ Analytical Platform is revolutionizing biopharmaceutical development — streamlining processes, reducing risks, and accelerating your pathway to success.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Sample Quality Control For Vaccine Development - Agilent Technologies

LC/MS/MS Analysis Of Coproporphyrin 1, Coproporphyrin 3 - Aliri Bioanalysis

Connect With Bioprocess Online: