Newsletter | November 7, 2024

11.07.24 -- Life Sciences Cybersecurity Incident Management: The End-to-End Approach

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eData Exchange: Embark on your Digital Transformation Journey

Discover the transformative advantages of raw material eData exchange, the innovative eMERGE™ program, and valuable insights on digital transformation in the pharma and biopharma industries. Learn more here.

FOCUS ON ANALYTICS & QUALITY

Life Sciences Cybersecurity Incident Management: The End-to-End Approach

Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.

Developing New Medicines Through Artificial Intelligence

Embrace the future of drug development by leveraging AI and innovative protein synthesis technologies to accelerate the creation of effective therapies and transform patient outcomes.

The Role Of Extractables Data In The Adoption Of Single-Use Systems

Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.

The Industrial DataOps Solution For Industry 4.0

HighByte Intelligence Hub is a DataOps software solution purpose-built for industrial data that enables manufacturers to securely connect, model, condition, and flow valuable industrial data to and from IT systems without writing or maintaining code.

Real-Time Monitoring: Why Have It And How To Get It

Uncover how automation and real-time monitoring across all process steps provide the rapid response and control needed for successful continuous manufacturing.

How Digital Twins Are Redefining Biotech Production And Labor

Digital Twins are revolutionizing biotechnology by optimizing production processes, enhancing quality control, and changing the workforce, offering efficiency, predictive maintenance, and compliance benefits.

A Streamlined Flow Cytometry Workflow

Examine the usability and performance capabilities of a system that provides a streamlined flow cytometry workflow, from instrument initialization to data acquisition and analysis.

ANALYTICS & QUALITY SOLUTIONS

Process Trains For Flexible, Configurable Biopharma Manufacturing Capacity - Cytiva

MasterControl Quality Management System (QMS) - MasterControl, Inc.

STELLARIS DLS Digital Light Sheet Microscope - Danaher Life Sciences

hMSC & EV Analytical Services - RoosterBio

Microcalorimetry: RS-DSC, DSC & ITC - TA Instruments

FOCUS ON REGULATORY

Safety Cabinets' Essential Role In EU GMP Annex 1

A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and and installation, per Annex 1.

A Risk-Based Approach To Validation Studies For Filtration

One way to address risk related to product quality is by implementing a Question-based Review approach. Read on to learn about this approach and its advantages.

Safer Single-Use Materials To Enhance Advanced Therapy Manufacturing

Single-use tech suppliers must align with advanced therapy manufacturers to de-risk manufacturing processes and chemical composition requirements to maintain the safety and efficacy of treatments.

Selecting An Aqueous Cleaning Detergent

Explore aqueous detergent selection criteria as it fits into three broad categories: function and efficacy, health and safety, and environmental.

Biological Indicators - Identification And Purification

In this session, an expert walks you through the purity testing process and explains identification methods for biological indicators to help end users.

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