Newsletter | September 18, 2025

09.18.25 -- Blood Plasma Fractionation: Engineering And Facility Design For The Future Of Biotherapeutics

SPONSOR

Join Bioprocess Online Live on October 7 at 11am ET for an interactive discussion on evolving CMC strategies for ADCs with leading experts in the space. This Q&A will feature CrossBridge Bio’s CEO and co-founder, Michael Torres, Ph.D., and acting CTO, Morris Rosenberg, Ph.D., as well as Borys Shor, Ph.D., an advisor to OS Therapies and director at Manhattan BioSolutions. Registration is free for this digital event thanks to Cytiva.

FOCUS ON FACILITIES DESIGN

Blood Plasma Fractionation: Engineering And Facility Design For The Future Of Biotherapeutics

This article shares key considerations for bioprocessing facility design for plasma-derived medicinal products.

The Hidden Costs Of Equipment Storage: What You're Really Paying For

Don't let idle assets drain your resources. Uncover the often-overlooked expenses of equipment storage, from rental fees to lost opportunity costs, and learn how to reclaim value.

Extractables And Functional Design In Bioprocessing Film Development

Learn more about a single-use film that is engineered for durability and minimal extractables to enhance efficiency, reliability, and product quality across diverse applications and environments.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Building the right cleanroom involves critical early decisions. Learn about a methodical framework ensuring flexibility, compliance, and operational readiness from initial concept through delivery.

Critical Cleaning For 3D Printing In The Life Sciences

Learn about the critical cleaning of hard surfaces utilized in 3D printing processes across industries, such as extruded plastics, photosensitive substrates, metals, and metal alloys.

Environmental Monitoring Handbook For Pharmaceutical Manufacturers

Acquire a thorough understanding of environmental monitoring, covering the fundamentals of particle counting and cleanroom designs, regulatory expectations regarding market release, and more.

Demonstrated Strength And Durability Of Ultimus® Film

Here, we outline the development of Ultimus® film and summarize the strength and robustness tests conducted in accordance with the American Society for Testing and Materials (ASTM).

FACILITIES DESIGN SOLUTIONS

Clean In Place Detergent For The Life Sciences Industry - Alconox Inc.

PharmaLok ZerO Sanitary Clamps - Nordson MEDICAL

DEHP-Free CryoProtect™ Bio-Containers - Charter Medical

Strategic Monitoring: Leveraging FMS Web Client Floor Plan Mapping - TSI Incorporated

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Delve into trending topics and pressing challenges facing the pharmaceutical industry at the 2025 ISPE Annual Meeting & Expo with experts from around the world. Explore a wide range of topics, including emerging trends in advanced therapies, practical risk-management approaches to enable innovation, strategies to help streamline validation, support for sustainability efforts, and opportunities to drive digital transformation. Learn more and register here

FOCUS ON MANUFACTURING CONTROLS

Exploring The Potential Of Agentic AI

Learn how agentic AI is poised to transform Enterprise Asset Management in regulated industries to enhance compliance, reduce downtime, and bridge fragmented systems for resilient operations.

AI Predictive Maintenance Prevents Batch Loss And Production Shutdown

AI-powered predictive maintenance with wireless vibration sensors prevented costly batch loss and production shutdowns in pharma manufacturing by detecting and fixing equipment issues before failures occurred.

Drive Innovation With Validation 4.0

Discover how Validation 4.0 can revolutionize your organization by boosting innovation, efficiency, and compliance with strategies that overcome challenges and stay ahead of evolving regulations.

Digital Transformation Optimizes Production, Quality, And Compliance

Examine how advanced automation solutions at Fermion's new facility were implemented to enhance production, quality, and compliance in pharmaceutical manufacturing while meeting industry standards.

AI-Powered Visual Inspection: Boosting Efficiency In Production

Understand how AI is transforming visual inspection and gain a deep understanding of defect detection, real-time performance, and integration challenges.

The Power Of Digital Twins In GxP Pharma Manufacturing

Explore how digital twins revolutionize pharma manufacturing by enhancing bioprocess efficiency, ensuring compliance, leveraging AI and IoT, and safeguarding product quality.

Simplifying Recipe Creation In The Life Sciences

Discover how an innovative SaaS-based workflow management solution is transforming pharmaceutical manufacturing to enable agility and innovation in personalized medicine.

Frequently Asked Questions: New Cloud-Based Monitoring Platform

Monitor assets in real-time, anticipate issues, and maintain optimal performance effortlessly by exploring a cloud-based asset monitoring platform that offers proactive support and rapid response from experts.

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The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. Register today!

MANUFACTURING CONTROLS SOLUTIONS

Moving Visual Inspection Into Pharma 4.0 With The Identifier Software - InQuest Science

Composable MES For Pharma - Tulip

Evolve From Paper To Digital Operations Quickly And Simply - Aizon

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

Flexible Manufacturing Solutions For Evolving Industry Needs - Jubilant HollisterStier

Ensure Consistency Across Batches With A Powerful Tool - Thermo Fisher Scientific

A Solution Brief For Life Sciences - HighByte

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