Newsletter | June 12, 2025

06.12.25 -- Validation, PAT, And AI In Fed-Batch And Continuous Environments

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Explore the latest biotech equipment and solutions — all online, wherever you are.

Don't miss the next Bio-Expo Live! This interactive, multi-day event is organized by stages of drug development and production, making it easy to find sessions tailored to your company's needs. Browse the full agenda and register for free to join the conversations most relevant to your work.

FOCUS ON MANUFACTURING CONTROLS

Validation, PAT, And AI In Fed-Batch And Continuous Environments

In this Bioprocess Online Live event, David Bruehlmann, Ph.D., addresses questions on process analytical technology validation, stressing the importance of process understanding.

Integrating CPV, APQR Data, And Workflows To Reduce Redundant Activities

Experts in the pharmaceutical industry share insights on how to effectively implement a strong, integrated CPV and APQR framework. Watch now and learn how automation enhances efficiency.

10 Steps To Designing An Industrial Data Architecture For Scale

Manufacturers generate vast amounts of data daily but struggle to make it actionable. Walk through these 10 steps and questionnaires to help you transform raw data into valuable insights for your company.

Why Manual CQV Costs More Than You Think

Discover how modernizing commissioning, qualification, and validation processes in pharmaceutical and biotech manufacturing can streamline operations, reduce risks, and enhance efficiency.

Evolving Into Biopharma 4.0: A Stepwise Journey Of Digital Transformation

You don’t need to make huge investments to shorten time-to-market. Watch to discover how incremental steps can transform your processes using digitalization and automation.

Monitoring And Determining The Cause Of Antibody Discoloration

View a study which provides additional insight into the factors that govern the discoloration of protein therapeutics and the role of AGEs in color change.

The Future Of Compliance, Efficiency, And Data Integrity

Explore how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

Supplier Quality And The True Cost Of Recalls

Recalls can cost millions (or even billions) and threaten a company’s public perception. See how to minimize recall costs and enhance compliance with effective quality management strategies.

Driving Continuous Improvement In The Digital Age

Uncover the need for organizations to modernize Quality Management Reviews (QMR) through digital tools and analytics to enhance efficiency, collaboration, and continuous improvement.

Addressing The Evolving Needs Of Variable Drug Delivery Regimens

Pharmaceutical companies now have a wearable solution designed to enable new delivery formats in alternate settings and customization to support adjustments to formulations and variations in treatment.

How A CDMO Gained 40%+ Efficiency By Generating Automated APQRs

Find out how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.

Build Better BioTherapeutics Using Machine Learning And Synthetic Biology

Learn about high throughput biologic automation and GMP master cell banking services as well as variable selection services that search the SQL space to find promoters.

Unlocking Agility And Efficiency In Biomanufacturing

Examine a standardized yet flexible modular biomanufacturing system designed to accelerate timelines, improve scalability, and enhance quality while reducing costs and environmental impact.

MANUFACTURING CONTROLS SOLUTIONS

The Leading Electronic Quality Management System (eQMS) - ETQ

Efficient Process Lifecycle Management For Optimized Drug Development - IDBS UK HQ

One Bioprocess Controller For All Your Needs - Eppendorf SE

Quality And Risk Management Software For Life Sciences - Honeywell Life Sciences

Simplify And Streamline Your Processes With Sanitary Clamps - Nordson MEDICAL

A Solution Brief For Life Sciences - HighByte

A Leading Digital Validation Platform For Life Sciences - Kneat Solutions

Electronic Batch Recording Software For CGT - Koerber Pharma

FOCUS ON FACILITIES DESIGN & MAINTENANCE

Prioritize Cleaning And Disinfection During Facilities Design

Thorough consideration of cleaning/disinfection during facility design eases maintenance across the facility lifecycle, optimizes workspace utility, and contributes to efficient facility operation.

Steps For Proper Cleaning Validation

Gain insight into the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.

Five Habits For Reliable Biomanufacturing

Implement strategies to reduce unplanned downtime and keep your biomanufacturing on track with a checklist that covers maintenance, monitoring, and contingency planning to enhance reliability.

Filling Industry Gaps With Dedicated Cell & Gene Therapy Fluid Transfer Sets

Read how the incorporation of transfer sets designed to support CGTs will aid in the implementation of controllable, consistent, and safe cGMP amenable manufacturing procedures.

FACILITIES DESIGN & MAINTENANCE SOLUTIONS

Rapid Nanomedicine Formulation - Cytiva

Remote Cleanroom Microbial Air Sampler (Annex 1-Compliant) - Particle Measuring Systems

Cleanroom Manufacturer Expands Capacity To Meet Industry Needs - AES Cleanroom Technology

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