Newsletter | January 24, 2025

01.24.25 -- Political Influences And Regulatory Implications For Biotech In 2025

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Let Us Handle Your Buffer Preparation

Thermo Fisher Scientific is here to support you with the buffer preparation in your manufacturing workflow. Leaving the non-core activities to us enables you to focus on the patient therapy development. Our capabilities cover off-the-shelf products like WFI, NaOH, NaCl, or EtOH, a library of the most frequently used buffers that are made-to-order, as well as fully customized buffers.

FOCUS ON REGULATORY

Political Influences And Regulatory Implications For Biotech In 2025

In this segment of the executive roundtable discussion, our panelists discuss the changing political landscape and its potential effects from a regulatory and economic point of view.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

Steps For Proper Cleaning Validation

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

Avoiding The Pitfalls Of PQR

Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

FDA Recalls: Why They Happen And How to Avoid Them

This guide offers life sciences professionals valuable insights into the reasons behind FDA recalls, their consequences, and how innovative solutions can help companies avoid them.

Powering Sustainability In Pharma

These best practices, real-world examples, and industry insights can guide you in enhancing productivity and ensuring regulatory compliance while maintaining the highest quality standards.

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Following its popular inaugural 2024 Bio-Expo Live, Bioprocess Online brings you the next opportunity to advance your drug development agenda. Over just a small portion of your week and from the comfort of your computer, discover the latest solutions in upstream and downstream bioprocessing as well as bioprocess quality, data, and analytics. 15-minute presentations from leading suppliers will give you just the right insight to make your next best move in drug development. Register here.

FOCUS ON QUALITY/ANALYTICAL METHODS

Novel Biological Responses For Robust Cell-Based Potency Assays

Ensure the potency and efficacy of your biologic products with Catalent's GMP-compliant potency bioassay, offering accurate real-time assessments for GMP release and stability testing.

Innovating The mAb Characterization Process

Understanding the characteristics of a molecule's "personality" is crucial for optimizing development and manufacturing. Learn how to overcome the challenges in the characterization process.

Keeping Up With New Emerging Analytical Technology

Explore advancements in emerging analytical technologies like Process Analytical Technology (PAT) and mass spectrometry, improving drug development through enhanced bioprocess monitoring and control.

Immunophenotyping Of Whole Blood Using BD Flow Cytometry

In this study, a fully automated workflow utilizing the BD FACSDuet Premium Sample Preparation System integrated with the BD FACSLyric Flow Cytometer was assessed and compared to manual processing.

HCP Detection And Quantitation

Learn the ins and outs of host cell proteins (HCPs), HCP ELISA, and HCP contaminants, as well as how to improve your recombinant protein production.

Bridging The Gap Between Traditional Organ-Chip Models, Human Biology

Whether you are new to Organ-on-a-Chip technology or seeking to expand your expertise, watch to gain the knowledge and insights needed to effectively implement this technology into your research.

QUALITY/ANALYTICAL METHODS SOLUTIONS

Multiplexed Digital PCR With The QX ONE ddPCR System - Bio-Rad Laboratories, Inc.

A Tool To Support Your Everyday Analytical Needs - IDBS UK HQ

Understanding The Intricacies Of qMSI - Aliri Bioanalysis

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