Newsletter | March 6, 2025

03.06.25 -- Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings

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The rapid advance of ADCs has tested the fine balance between speed to IND and process development that stands up to the rigors of scale-up and transfer. Explore the processes leading ADC developers are employing to mitigate manufacturing-scale risk, and how automation and artificial intelligence are beginning to inform their work. Join Bioprocess Online Live for this interactive discussion. Registration is free thanks to the support of Thermo Fisher Scientific.

FOCUS ON FACILITIES DESIGN & MAINTENANCE

Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings

Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.

Discover The World Of Digital Twin Technology

Create a virtual replica of your facility or equipment to enable the highest levels of operational readiness and excellence.

Sustainability And Corporate Responsibility In Capital Asset Management

Learn how pharmaceutical companies can reduce waste, cut emissions, and improve financial performance by prioritizing equipment reuse and optimizing asset management.

Bacteria To Consider For The Growth Promotion Test

The Growth Promotion Test (GPT) evaluates whether the culture media is suitable for use in environmental monitoring sampling. Explore recommendations to follow to ensure a successful GPT.

Extractables In Single-Use Systems Used In ADC Manufacturing

To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

Reducing Risks In Your SIP Validation Cycles

Utilizing tape for positioning during Sterilize in Place (SIP) validation can introduce numerous issues. Explore the top eight reasons why tape should be avoided during SIP validation cycles.

Embarking On A Successful Cleanroom Project: Conception To Delivery

Learn how you can obtain comprehensive solutions for cleanroom projects that help you ensure regulatory compliance and operational efficiency.

Empowering Biopharma With Single-Use Cryopreservation Solutions

Explore four common applications of cryopreservation and the science behind selecting the appropriate materials to build single-use solutions that enable cryogenic storage for cell and gene applications.

Clarification Efficiency: Analyze The Bio-Separation Of CHO-S Cells

Could this single-use centrifugation be the solution to optimizing your clarification process by purifying and concentrating CHO-S cell feeds with low shear stress and minimal impact to cell viability?

Improved Viable Particle Discrimination With Real-Time Particle Counter

A new algorithm developed by a real-time viable particle counter determines the viability of a particle based on its measured optical properties, improving the detection of microorganisms.

FACILITIES DESIGN & MAINTENANCE SOLUTIONS

Biological Indicators To Fit Your Needs - Mesa Laboratories

Lancer Ultima Series Labware Washing Systems - Getinge

A Single-Use, Automated Depth Filtration System - Cytiva

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Webinar: Do Not Bear Cross Contamination in the Pharmaceutical Industry – Prevent it

Save the date to explore how process optimization plays a key role in achieving effective critical cleaning in pharmaceutical manufacturing. Learn how optimizing cleaning chemistry, selecting the right detergents, and refining process parameters can prevent cross-contamination, improve efficiency, and ensure product quality. Hear case studies on enhancing compliance, reducing costs, and meeting regulatory standards for safe, quality production. Click here to learn more.

FOCUS ON MANUFACTURING CONTROLS

Streamlining Drug Development With The Right Digital Tool

The BioPharma industry must shift from data collection to process knowledge, leveraging digital tools to optimize drug development, enhance quality, and streamline tech transfer through digital maturity.

Digitalizing Pharma Control Strategies: A Roadmap

Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

AI-Driven Spatial Proteomics Reveals Immune Diversity In 4T1 Tumor Model

AI-driven spatial proteomics in 4T1 murine tumors reveals diverse immune populations, and pro-tumorigenic environments, advancing insights into tumor progression and therapeutic resistance.

Understanding Nitrosamines: Key Regulations And Best Practices

Gain expert insights into nitrosamine regulations and discover practical strategies for ensuring compliance and safeguarding product safety.

If Your Data Could Talk...

Explore two examples where data contextualization plays a critical role in a biopharma manufacturing environment, and learn how to get your data to speak the same language across different systems.

How To Maximize Automation ROI In Modular Environments

To fully optimize their efficiency, modular facilities require integrated modular automation systems. Learn why modular automation is critical.

Biomolecular Characterization With Mass Photometry

What is mass photometry and how is it used? Explore this powerful analytical technology that measures the mass of single particles in solution accurately and without labels.

Modern Industrial Data Architecture Strategies And Best Practices

Explore the processes and technologies being utilized by life sciences manufacturers to achieve success on their Industrial DataOps maturity journey as well as real-world best practices from the field.

MANUFACTURING CONTROLS SOLUTIONS

Quality Risk Management Software - MasterControl, Inc.

Boston, MA: Process, Analytics, And Manufacturing Facility - Resilience US, Inc.

Novel Cell Lysis Solution: Scaling Up The Harvest Process - Avantor

Take The Right First Step To Manufacturing Digitalization - Aizon

Data Harmony – Your Data, Always Available - Eppendorf SE

Reduce The Burden Of Software Validation Testing - ValGenesis

Batch Manufacturing Software For Pharma - Honeywell Life Sciences

Slurry Bin Functionality With The DAC Ergo - Asahi Kasei Bioprocess

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