Newsletter | November 14, 2024

11.14.24 -- The Complex Regulatory Landscape Of Flow Cytometry For Cell Therapy

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FOCUS ON REGULATORY

The Complex Regulatory Landscape Of Flow Cytometry

Flow experiments must be controlled to produce consistent data. With a gush of new technology, regulators have put more scrutiny on flow cytometry-based approaches.

How Generative AI Streamlines GxP Compliance In Life Sciences

Generative AI is reaching a critical juncture in the life sciences industry. Learn how it is changing the game for GxP Compliance and enabling organizations to improve operational efficiency.

The BIOSECURE Act: Implications For US Biopharmaceutical Companies

Uncover the implications of the BIOSECURE Act and how US-based pharmaceutical companies and CDMOs are adapting to the new legislative landscape in order to remain competitive.

PUPSIT As Part Of A Contamination Control Strategy (CCS)

Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

Streamlining Testing For Optimized mAb Production

Delve into the intricacies of mAb production, emphasizing the importance of accurate and precise testing at various production stages to help ensure product safety, quality, potency, and regulatory compliance.

REGULATORY SOLUTIONS

Pharmaceutical Automation And Information Technology Services - CAI

FOCUS ON ANALYTICS & QUALITY

Computer Systems Validation Pitfalls: Misinterpretations & Inefficiencies

In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

The Transformational Impact Of A Digital Backbone

Relying on fragmented data becomes problematic when teams need to dissect cell line performance data and that data is not in a digital backbone.

How To Value Automation With The Return On Invested Capital Model

Gain insight into the Return on Invested Capital (ROIC) advantages of an automated manufacturing facility and its correlation to the digital maturity of your operation.

Unveiling Critical Translational Biomarkers Through Single-Cell Analysis

single-cell analysis can be used to identify critical biomarkers, revealing functional heterogeneity among donor products and correlating them with clinical outcomes in adoptive cell therapy.

The Next Generation Of Thermal Stability Testing For Biologic Drugs

Achieving precise measurements in a high-throughput setting can be challenging without disrupting workflows or deadlines. Learn about a new tool for rapid biotherapeutic thermal stability characterization.

Bringing It All Together – Data Harmony In The Bioprocess Ecosystem

Discover how integrated solutions create a harmonious bioprocess ecosystem. Learn about data integration, digital technologies, and automation to streamline your lab workflow and drive innovation.

Revolutionizing Manufacturing For Pharma And Biopharma

Explore the evolution of Industry 4.0 in pharmaceutical manufacturing, the benefits and implications of Smart Factories, and the challenges along the road toward implementing a Smart Factory.

ANALYTICS & QUALITY SOLUTIONS

The Industrial DataOps Solution For Industry 4.0 - HighByte

BD FACSLyric Flow Cytometry System - BD Biosciences

Multichannel Verification System And Assay Optimization Platform - Advanced Instruments, Inc.

Aizon Execute - Aizon

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