Newsletter | February 6, 2026

02.06.26 -- New USP Research Shows MAM As Alternative To Conventional Methods

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Join us for February's Bio-Expo Live, a three-day virtual event designed to empower biopharma professionals with the chance to conveniently explore the newest equipment and offerings in Upstream Bioprocessing, Downstream Bioprocessing and Bioprocess Quality, Data, and Analytical Solutions. Registration is free, reserve your spot today!

FOCUS ON QUALITY/ANALYTICAL METHODS

New USP Research Shows MAM As Alternative To Conventional Methods

Results show the multi-attribute method provided superior specificity and detected molecular modifications far better than the status quo.

Colon Intestine‑Chip For Studying GI Disease Mechanisms

What are the application and benefits of Organ-Chips and what makes them superior to organoids in the study of GI-related diseases?

Make Your Production Sites Adaptable And More Efficient

Pharma faces mounting complexity and tighter margins, demanding agile, future-ready production. Discover how smart manufacturing enables faster adaptation and continuous therapy availability.

Fluorescent Western Blot Detection

Review this step-by-step guidance for fluorescent western blot detection, including membrane prep and antibody handling, to improve signal clarity and consistency across imaging platforms.

5 Key Principles Of Cleanroom Particle Counting

Explore the five essential principles of cleanroom particle counting and how they ensure compliance, prevent contamination, and protect product quality in highly regulated manufacturing environments.

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

New And Improved Analytical Methods For Traditional And Unique Modalities

Here, we share several challenges in biologics analysis and take a closer look at the advanced tools and methods being utilized to improve biophysical analysis reliability and efficiency.

Analyzing Biological Drug Effects In 3D

See how 3D tumor microtissues paired with fluorescence-based assays offer scalable, high-sensitivity drug testing to deliver stronger signals and reproducible results compared to monolayer cultures.

Comparing Use, Process, And Reproduction Of Two Fermentation Systems

Maximize your yield by choosing systems with active pH and oxygen control. Learn how environmental stability and strain diversity impact reproducibility during high-temperature yeast propagation.

The Art Of Phosphitylation

Phosphorylation is key for bioactives, with phosphoramidites favored for high selectivity. Find out how choosing specific protecting groups and new technologies fine-tunes the synthesis process.

Calculating The ROI Of EAM/CMMS For Pharma Manufacturers And CDMOs

Observe how modern EAM and CMMS systems help manufacturers reduce risk, improve compliance, and cut costs, as well as nine signs it’s time to move beyond outdated asset management practices.

Optimize DNA Clearance In High-Salt, GMP-Grade Purification Processes

Efficient hcDNA removal is vital for therapeutic safety and compliance. Examine how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.

Optimizing Bispecific Antibody Expression Via Multi-Omics Analysis

Gain insight into how diagnosing ribosome pausing sites and optimizing codon usage dramatically improves bispecific antibody titers, turning difficult-to-express candidates into viable therapeutics.

How Intelligent Automation Transforms CQV Workflows

Discover how intelligent automation is revolutionizing CQV in life sciences to eliminate manual bottlenecks, accelerate timelines, and enhance compliance in an era of increasing regulatory scrutiny.

AOC GMP Manufacture For A FIH Study

Successful development of AOCs for FIH studies requires robust GMP processes and efficient scale-up. A key step is careful management of a multi-day conjugation process with vital in-process checks.

Supporting The Future Of cGMP Drug Product Manufacturing

Read about how holistic training and validation services help manufacturers navigate complex regulatory demands and achieve operational readiness faster.

Revolutionizing Pharma Validation With AI

Validation in GxP environments is often the bottleneck in digital transformation—manual, repetitive, and complex. One company's Intelligent Agents are transforming that process.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Forge Biologics: Facilitating External Collaboration With Quality - Veeva

Contract GMP Biologics Analytical Services - Catalent

Increase Speed, Sensitivity, And Resolution With UPLC - Waters Corporation

Advanced Performance And Fluorochrome Flexibility - BD Biosciences

FOCUS ON REGULATORY

GMP Manufacturing Cycle Time Reduction

Identifying process redundancies and enhancing visual management allows manufacturers to stabilize workflows. These data-driven improvements can decrease operational variability by nearly 50%.

Improve Facility Monitoring Systems To Comply With Regulations

A facility monitoring system is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime.

A Sustainable Future: Phasing Out Animal Testing

Explore a practical roadmap for replacing animal tests with advanced molecular methods, as well as how regulatory updates and innovative technologies are shaping a sustainable future.

REGULATORY SOLUTIONS

Digital PCR System And 21 CFR Part 11 Regulations - QIAGEN

Innovating Unmet Needs For Next-Generation Cellular Immunotherapies - Femtobiomed Inc.

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