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Drug Master File Document Production Product Applications In Usa

10 applications found
In UsaAvailable In UsaNear Usa

FlowCam for Biopharma - Protein Aggregate Analysis in Therapeutics Development
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FlowCam for Biopharma - Protein Aggregate Analysis in Therapeutics Development

Discover a high-throughput flow imaging microscopy platform for characterizing API aggregates and other particulates in your protein, monoclonal antibody, or antibody-drug conjugate ...

ByYokogawa Fluid Imaging Technologies, Inc.  based in  Scarborough, MAINE (USA)


FlowCam for Biopharma - AAV Aggregation Detection in Gene Therapies
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FlowCam for Biopharma - AAV Aggregation Detection in Gene Therapies

Assess the stability and quality of the next generation of biotherapeutics designed to treat cancer, immunize against pathogens, and address genetic disorders. Flow imaging microscopy detects aggregation of viral vectors such as AAVs, lentiviruses, and retroviruses as well as non-viral therapies like LNPs and ...

ByYokogawa Fluid Imaging Technologies, Inc.  based in  Scarborough, MAINE (USA)


FlowCam for Biopharma - Cell Therapy Quality Control and Organoid Analysis
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FlowCam for Biopharma - Cell Therapy Quality Control and Organoid Analysis

Novel cell therapies show great promise as treatments for a variety of complex diseases including cancers and neurodegenerative disorders. Flow imaging microscopy supports drug product analysis in order to advance the development of these therapies. ...

ByYokogawa Fluid Imaging Technologies, Inc.  based in  Scarborough, MAINE (USA)


Solutions for Healthcare

Solutions for Healthcare

We create innovative, scalable thermoformed solutions that accelerate product development, simplify manufacturing processes, and empower the world’s leading healthcare brands to bring new therapies to market as quickly and efficiently as possible. From innovation to integration to industrialization, our solutions go beyond ...

ByPlastic Ingenuity  based in  Cross Plains, WISCONSIN (USA)


Molecular Sensors for Pharmaceutical Solutions

Molecular Sensors for Pharmaceutical Solutions

Bringing Big Pharma the Power of Continuous Quantitative Molecular ...

ByAtonarp Inc.   based in  Minato-Ku, JAPAN


Intelligent compliance solutions for pharmaceutical industry

Intelligent compliance solutions for pharmaceutical industry

Few industries are regulated as heavily as the pharmaceutical industry. Bringing a new product to market can take years and requires monumental effort. 3E Company stands ready with a comprehensive suite of products and services that can create efficiencies, support product stewardship, mitigate supply chain risk and improve compliance - ultimately shortening the time to get a product on the ...

By3E - SDS and EHS Compliance Data Management Solutions  based in  Carlsbad, CALIFORNIA (USA)


Solutions for benchtop single cell sorting and dispensing sector

Solutions for benchtop single cell sorting and dispensing sector

High Performance Across the Breadth of Biotech. The NX One is a perfect fit for a wide variety of sectors and application areas spanning fundamental biological research to industrial and clinical workflows. Access your cells faster and at a fraction of the ...

ByNodexus Inc.  based in  Hayward, CALIFORNIA (USA)


DNA-based Therapy Based on htDNA-chip®

DNA-based Therapy Based on htDNA-chip®

DNA-based drug development and production are playing an increasingly important role in modern medicine. The application of DNA-based therapy mainly includes DNA-encoded compound library for new drugs research, genetically engineered bacterias drugs, nuelic acid vaccines, recombinant antibodies, small nucleic acid drugs, and gene editing. Firstly, we can quickly promote the development of new drugs through the construction of DNA coding libraries. Secondly, we can realize the mass production of protein drugs, ...

ByCD Biosciences - htDNA-chip®  based in  Shirley, NEW YORK (USA)


Solutions for Pharmaceutical

Solutions for Pharmaceutical

Clinics and physicians rely on manufacturers to ensure drug efficacy of active pharmaceutical ingredients (APIs) and sterility assurance across the supply chain—for the health and safety of their patients. As a manufacturer, we understand that your choice of sterilization modality is unique. Enhancing the aseptic manufacture sterility assurance level (SAL) of pharmaceuticals without affecting drug efficacy is a critical requirement of terminal ...

BySterigenics U.S., LLC  based in  Oak Brook, ILLINOIS (USA)


EDXRF spectrometers for pharmaceutical industry

EDXRF spectrometers for pharmaceutical industry

The pharmaceutical industry is one of the most regulated industries. Contaminants in drug products are examined throughout the manufacturing process, since their presence affects drug stability, behaviour and toxicity. Therefore, regulatory bodies such as the European Medicines Agency (EMEA) and the American Food and Drug Administration (FDA) strictly enforce continuous and ongoing analysis of organic or inorganic impurities from raw materials, excipients and Active Pharmaceutical Ingredients (API) through ...

ByXenemetrix Ltd.  based in  Migdal Haemek, ISRAEL

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