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Application Note

Sterility Assurance for Stem Cell Therapies

Stem Cell Therapies Sterility Assurance from Particle Measuring Systems PMS

Stem cell therapies are becoming more important in the pharmaceutical industry. The genetic manipulations of the cells involved create a powerful tool to treat serious diseases, such as cancer. In 2017, the Food and Drug Administration (FDA) made several advancements towards regulation of stem cell therapy:

  • Published perspective on stem cell therapy in the New England Journal of Medicine
  • Increased regulation enforcement for stem cell clinics
  • Released new guidance, Regulatory Consideration for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

To regulate this industry, the FDA uses a risk-based enforcement approach with considerations for how and why the products are used. FDA’s discretion for how regulations will be enforced ends November 2020. Companies responsible for ensuring full compliance should contact the FDA before the cutoff to remove uncertainty regarding the regulatory status of their products and to determine whether the products are subject to premarket approval. FDA guidelines are intended to help bring innovative, safe, and effective products to patients as efficiently as possible.

Complete the form to download the complete paper

CONTAMINATION MONITORING SOLUTIONS
  • Contamination Monitoring System
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RELEVANT CONTENT

Maintaining Quality in Stem Cell Products: Recent Developments in Regulation (Series Part 1 of 4)

EU GMP Annex 1 – Insights and Updates

Three Core Events to Establish Environmental Contamination Control – Per EU GMP Annex 1

Data Trending Requirements Annex 1, Rev 12

Microbiological Plate Incubation and Pharmaceutical Risk Assessment

Steps to Ensuring a Successful Audit – Effective Risk Assessment Design Webinar

Considerations & Steps for building a Contamination Control Strategy (CCS)

Cleanroom Contamination Control Advisory Services during Covid

 

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Products

  • Aerosol Particle Counters
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  • Molecular Monitors
  • BioCapt® Certificate of Analysis (CofA)
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  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

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  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing

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About Us

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Particle Measuring Systems- EN/CH

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9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

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