Newsletter | August 12, 2025

08.12.25 -- Cell & Gene Therapy Regulatory And Compliance Solutions

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The PDA Pharmaceutical Microbiology Conference 2025 marks two decades of advancing microbiological science and practice. This milestone event brings together the global microbiology community, including experts from industry, academia, and regulatory agencies, to explore the evolving landscape of pharmaceutical microbiology. This year's theme, Microbial Resilience: Today's Response, Tomorrow's Plan, reflects our focus on navigating present-day challenges while building robust strategies for the future.

GxP Compliance Solutions For GMP/GLP Labs

Advanced microplate detection systems and software help ensure data integrity. Discover solutions and support that can enhance precision and compliance in your research and assays.

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Danaher Life Sciences

Explaining Mobile cGMP Facility Requirements And CQV Process

Watch as experts delve into Germfree's CQV process during a recent Mobile cGMP Facility build from concept to completion. Our CQV services cover all stages of your facility's lifecycle.

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Germfree

Lab Equipment Monitoring For The Modern Lab

The PHCbi brand LabSVIFT™ revolutionizes the way labs monitor and manage their equipment. This cloud-based platform leverages the power of the Internet of Things (IoT).

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PHC Corporation of North America

Comprehensive CMC-QC Solutions For Cell Therapy

Learn about comprehensive solutions for cell therapy quality control, including CAR/TCR detection, residual testing, and potency assays, ensure stability, and multi-batch validation.

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ACROBiosystems

GMP Fill System For Cell And Gene Therapy

The award-winning Alta™ automated bag filling system can be configured to accurately dispense therapeutic products or processing material from formulated bulk into aliquot bags.

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Invetech

De-Risk mRNA Regulatory Approvals

Gain insight into CQA characterization and lot release testing. Explore comprehensive product characterization of plasmid DNA templates and a full suite of compendial testing.

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MilliporeSigma

Digital PCR System And 21 CFR Part 11 Regulations

Learn how an increase in adopting electronic records and signatures to enhance data management requires compliance with FDA regulations to ensure secure, traceable systems.

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QIAGEN

Trusted Partner For Clinical And Regulatory Success

Novotech’s team offers customized, end-to-end clinical and regulatory solutions, guiding biotechnology, pharmaceutical, and medical device companies through the entire product lifecycle.

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Novotech

Gain Support For Your Regulatory Submission Process

Join us in this video as we delve into invaluable tips, cutting-edge tools, and unwavering support that Cytiva offers to facilitate your documentation progress.

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Cytiva

Full Service CRO And Regulatory Partner For Biologics

Trust Veristat to guide your success in mitigating risks and efficiently bringing your biologic towards its next development milestone, all while ensuring patient safety and access.

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Veristat, Inc.

Understanding The FDA Recall Risks And Solutions For Life Sciences Manufacturers

Investigate the factors contributing to FDA recalls, the effects on both consumers and businesses, and how integrated digital solutions can play a crucial role in preventing such incidents.

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MasterControl, Inc.

Regulatory Considerations When Choosing Stem Cell Media

Explore key considerations for researchers moving from academia to industry or expanding their operations and crucial criteria for selecting the right stem cell media and supplier.

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Sartorius

Cell & Gene Therapy Solutions

Cencora's integrated, end-to-end solutions enable launch success with broad and deep consulting expertise, flexible to meet you where you are, from discovery through commercialization.

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Cencora

Fast-Track Bioanalysis And QC With Scalable Innovative qPCR Tools

Explore various innovative qPCR tools that automate and optimize laboratory workflows, and expedite bioanalysis and quality control in the rapidly growing field of cell and gene therapy.

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Applied Biosystems by Thermo Fisher Scientific, qPCR