Newsletter | January 15, 2026

01.15.26 -- Single-Use Standards Are Maturing, But The Process Remains King

FOCUS ON MANUFACTURING CONTROLS

What Will Allow For True Digital Twins?

In this segment from the Bioprocess Online Live event “How Digital Tools Are Accelerating Biopharma Development,” panelists Moiz Diwan, Ph.D. (AbbVie), and Kat Kozyrytska (independent technology consultant) consider the factors that need to come together to actualize digital twins for process development.

The Best Regulatory Practices For Lifecycle Management

Discover how Quality by Design strategies can reduce regulatory burden, simplify post-approval changes, and improve lifecycle flexibility while maintaining product quality and supply continuity.

Proven Strategies For GxP Compliance And Inspection Readiness

Struggling with data integrity challenges? Learn about proven strategies for GxP compliance and inspection readiness, as well as how to build a robust framework and avoid common pitfalls.

Modern Control Systems Enable Step Change Improvements

Modern control systems are helping manufacturers improve traceability and streamline compliance. Explore how digital tools are simplifying migration and enabling smarter, more connected operations.

The GxP Digital Maturity Model

Find out how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.

The Right Partnerships Are Key To Streamlined Drug Development

Examine how to select the right CDMO partner for your pharmaceutical project to navigate the evolving drug development landscape and ensure successful outcomes.

Increasing Batch Size And Reducing Cycle Times For A Biologic

JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.

Elevating Downstream Process Development With Real-Time Data Monitoring

Reveal how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.

Biopharma's Path To MES In The Cloud

The industry is shifting to cloud-based Manufacturing Execution Systems (MES). See how you can use a modern MES to enhance efficiency, collaboration, and compliance.

From Paper To Performance: A Journey Toward Smart Manufacturing

As the digital backbone for real-time production control and data integrity, review how a manufacturing execution system (MES) orchestrates production processes from start to finish.

The Benefits Of Automating Your Requirements Traceability Matrix

The Requirements Traceability Matrix ensures every system requirement is verified through testing, supporting compliance, reducing risk, and strengthening validation efforts across development.

De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions

Learn more about a disposable pen for Liraglutide 3.0 mg that demonstrated comparable usability to the reference device, helping de-risk ANDA submissions through proactive human factors evaluation.

Partner Case Study: Accelerating Gene Editing Manufacturing

Read about how a new partnership is advancing base editing therapy for sickle cell disease, combining cutting-edge science with streamlined manufacturing to accelerate clinical trials.

Innovative AI Software Solutions Driving Biomarker Research Efficiency

Watch to discover how AI-powered tools streamline biomarker discovery, enhance data analysis, and improve research efficiency in personalized medicine.

Prioritizing Data Security Through Digital Transformation

Integrating advanced digitalization solutions and prioritizing data security can accelerate drug development while reducing costs and ensuring consistency across a global network.

MANUFACTURING CONTROLS SOLUTIONS

Solutions For Advanced Scientific Research - LICORbio

Built-In Knowledge For Planning And Controlling Runs And Analyzing Results - Cytiva

At-A-Glance Monitoring - TSI Incorporated

Simplify Assembly And Save Time - Nordson MEDICAL

Easy-To-Use 1 mL Disposable Autoinjector - BD Medical - Pharmaceutical Systems

Why The Right Electronic Logbook Solution Matters - Honeywell Life Sciences

Obtain Uniform Compression With Sanitary Clamps - Nordson MEDICAL

Enterprise Maintenance Management - Blue Mountain

High-Precision Z-Axis Nanopositioning - Mad City Labs, Inc.

Bio-Expo Live: Downstream Bioprocessing - Aizon

FOCUS ON FACILITIES DESIGN & MAINTENANCE

Single-Use Standards Are Maturing, But The Process Remains King

The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.

The Case For Pre-Owned Equipment In Drug Manufacturing

Explore how used equipment can deliver faster ROI by eliminating long lead times and reducing capital outlay, allowing for quicker production and revenue generation.

FACILITIES DESIGN & MAINTENANCE SOLUTIONS

Advanced Single-Use Mixing Technology - Repligen

Connect With Bioprocess Online: