Newsletter | May 1, 2025

05.01.25 -- A Closer Look At Buffer Recycling For More Sustainable Bioprocessing

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Multispecific molecules bring added complexity to downstream purification—think incorrect chain pairings, aggregation, fragmentation, and lower yields. Join Bioprocess Online Live as we explore how developers are addressing these challenges to achieve high purity and efficient processes. Gain insights into key considerations for downstream teams when designing purification strategies for these advanced biologics. Registration is free thanks to the support of Thermo Fisher Scientific.

FOCUS ON FACILITIES DESIGN & MAINTENANCE

Experts' Advice On Facility Design And Construction

This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.

A Closer Look At Buffer Recycling For More Sustainable Bioprocessing

Recognizing the unexplored potential to save resources, one researcher realized consumption reduction of up to 50% during a key phase of downstream processing.

The Problem With Construction Quality

Hundreds of issues plague data center commissioning, mostly due to construction errors. Discover how a shift from quality assurance to robust quality control can prevent costly rework.

Improve Single-Use Training Through Vendor And End-User Collaboration

Learn about a combination of teaching methodologies that facilitate engaging and efficient training on single-use technology to help users of all skill levels prevent damage and leakage.

Poking And Prodding The Molecules Of Life

Using advanced biophysical techniques, researchers have shed light on the dynamic behavior of individual biomolecules, driving breakthroughs in our understanding of life's molecular intricacies.

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.

Vaporized Hydrogen Peroxide (VHP) Resistance Testing

Explore test results demonstrating the suitability of a robust microbial sampler for environments where frequent exposure to harsh cleaning and sterilization methods, like VHP in isolators, is routine.

Tips For Designing A Single-Use Manifold For Advanced Therapies

Expert single-use engineers address six common questions posed by cell and gene therapy manufacturers in the design of custom single-use manifolds for the critical handling of biological fluids.

FACILITIES DESIGN & MAINTENANCE SOLUTIONS

Self-Contained Biological Indicator For Monitoring Steam Sterilization - Mesa Laboratories

Implementation Of Multi-Column Chromatography Systems - MilliporeSigma

Multi-Use Bioreactor Washing And Sterilization - Getinge

Cleaning Coveralls And Other Potentially Contaminated PPE - Alconox Inc.

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The biotechnology sector is transforming with AI, automation, and digitalization playing key roles in drug development and manufacturing. As the industry moves toward end-to-end digitalization, don't miss the opportunity to join the 2025 ISPE Biotechnology Conference, 2 – 3 June in Boston, Massachusetts, USA, and virtually, to gain a holistic perspective on how to view and apply digital transformation in biopharmaceutical manufacturing. Register today: visit ISPE.org/Bio25.

FOCUS ON MANUFACTURING CONTROLS

Rapid Thermal Stability Screening Of High Concentration Biologic Drugs

Explore data demonstrating the effectiveness of a rapid screening-differential scanning calorimeter as well as its detection limits and the range of concentrations suitable for DSC analysis.

Leveraging AI To Build Process Intelligence

Accelerate drug development with AI. Enhance process intelligence and achieve gold-standard data sets with the right digital tools and improved maturity.

Mastering Technology Transfers: Our Blueprint For Success

Uncover how this expert approach to process transfer supports reliable, scalable commercial manufacturing in the rapidly growing biopharmaceutical market.

Adapting To Evolving Regulations: Validation In A Changing Landscape

Discover how evolving regulatory expectations in life sciences present new challenges and opportunities, as well as gain insight into strategies from experts in the field to navigate risk-based validation processes.

Understanding Technology Transfer In Pharma Contract Manufacturing

Technology transfer is a crucial process in the pharmaceutical industry, ensuring drugs developed in labs can be manufactured consistently at scale.

4 Steps To Implementing Predictive Quality Analytics In Manufacturing

Stay competitive in Industry 4.0 by exploring how predictive quality analytics, powered by AI and ML, transform manufacturing by predicting outcomes, optimizing processes, and minimizing disruptions.

Leveraging Digitalization To Resolve CGT Manufacturing Challenges

Uncover digitalization's role in overcoming manufacturing challenges in cell and gene therapies to enhance efficiency, quality, and scalability through data analytics and real-time monitoring.

How A Leading CDMO Reduced Yield Variability With Automation

Explore the transformative journey of a leading CDMO company and how they adopted an innovative platform that enhances data analytics and drives pharmaceutical manufacturing advancements.

Data Modeling Best Practices And Pitfalls For Pharma 4.0

Explore best practices that serve as a guideline for commonly encountered data modeling challenges and how life sciences manufacturers can overcome them by leveraging an Industrial DataOps solution.

Pushing Boundaries In Biophysics And Biomanufacturing

Gain valuable perspectives on the future of biomanufacturing, including the impact of data science, automation, and continuous learning, shared by an experienced biophysics specialist in the field.

MANUFACTURING CONTROLS SOLUTIONS

A Biotech Solution For Biopharma Excellence - Koerber Pharma

Leave Paperwork Behind In Your CQV Process - ValGenesis

Biopharma Manufacturing Process Data Made Simple - Danaher Life Sciences

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