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Microbiology & Quality Associates, Inc.

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Concord, California, US

About Microbiology & Quality Associates, Inc.

Founded: 2006 Type: Privately Held Size: 11-50 employees

Microbiology & Quality Associates, Inc., located in the San Francisco Bay Area, is a service organization providing a variety of services to life sciences companies. Our services include: contract biotech development services, microbiology, virology, and analytical testing services, cell culture services,... Show more »

Microbiology & Quality Associates, Inc., located in the San Francisco Bay Area, is a service organization providing a variety of services to life sciences companies. Our services include: contract biotech development services, microbiology, virology, and analytical testing services, cell culture services, molecular cell biology assays, mycoplasma detection by PCR, consulting, validation services, calibration services (pipettes, balances, incubators, freezers, etc.), training courses, and scientific resources. MQA is FDA registered. Our Quality System comply with GMP/GLP regulations and ISO 17025/9001.

We provide services to a wide variety of companies in biotechnology, pharmaceutical, medical devices, nutritional products, dialysis centers, semiconductors, and other industries.


Certifications:

  • FDA registered
  • GMP/GLP
  • ISO 17025/9001

Standard sample shipment requirements:
Microbial samples must be shipped overnight cold. Cells must be shipped frozen.


Relevant publications:
Prevalence of Bacterial Contamination of Glucose Test. R. Johnston MQA, http://www.whitehatcom.com/ADC/Resources/Ron_NG_Multicenter_evaluation_of_bacterial_contamination_of_glucose.pdf

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Our Services (75)


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Cosmetic and Personal Care Product Testing

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ADCC and CDC Assays

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ICH Stability Testing

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In vitro Angiogenesis Assays

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Chemotaxis Assays

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Cell Migration Assays

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In vitro Immunotoxicity Testing

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Cytotoxicity Assays

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Cell Invasion Assays

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Apoptosis Assays

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Cell Line Generation

Price on request

Stable Cell Line Expression:

For either over or knock-down by shRNA. Stable cell lines with specific gene over-expression or knock-down are very helpful in gene function analysis, target discovery, target validation, assay development, and compound screening. MQA’s team of experienced scientists will work with you to... Show more »

Stable Cell Line Expression:

For either over or knock-down by shRNA. Stable cell lines with specific gene over-expression or knock-down are very helpful in gene function analysis, target discovery, target validation, assay development, and compound screening. MQA’s team of experienced scientists will work with you to establish the system to generate your particular cell line for your specific application. Since long-term suppression using pol III shRNAs can be problematic especially for studies of genes that are critical to cell proliferation and differentiation, we provide not only constitutive but also conditional knock-down.

Primary cell line generation:

Primary cells are cells straight from the tissue with no passages. A primary cell culture may be composed of mixtures of cell types. Frequently, some of the cells may survive without proliferating, and will therefore be lost in the increasing population of those which are able to multiply in the conditions supplied in vitro.

Cells from explants may sometimes be converted to cell lines by passage. These may continue to proliferate for a number of cell generations.

MQA also offers cells for use of primary fibroblasts as feeder layers for the growth of some embryonic stem cell types. At MQA, our scientists can prepare primary cell lines from most tissues using our standard protocols. If you would like to implement a custom project, we would be happy to discuss your project specifications with you.

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ELISA

Enzyme-linked immunosorbent assay
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USP Water Testing

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The following tests are required to meet USP and EP test requirements: Conductivity, Total Organic Carbon (TOC), and Bioburden (plus bacterial endotoxin in the case of WFI Water used to manufacture products for Europe must meet EP test requirements for heavy metals and nitrates.

Microbiology & Quality Associates (MQA) provides... Show more »

The following tests are required to meet USP and EP test requirements: Conductivity, Total Organic Carbon (TOC), and Bioburden (plus bacterial endotoxin in the case of WFI Water used to manufacture products for Europe must meet EP test requirements for heavy metals and nitrates.

Microbiology & Quality Associates (MQA) provides sampling, and microbiological and chemical testing services for water systems 7 days a week.

Tests Performed

Lab Reagent water: Bioburden, Conductivity, pH, Silica and total organic carbon
Potable water: Bioburden, Chlorine, Coliform, Conductivity, Copper, Hardness, Iron, pH, Silica, Sodium, and total organic carbon
Purified water: Bioburden, Conductivity, and total organic carbon
Water for Injection (WFI): Bioburden, Conductivity, Endotoxin, and total organic carbon

USP <645> Conductivity test for water samples – Test performed at Stage 1. If needed retest on Stage II for additional $30, and if stage II fails retest on Stage III for an additional $50. Testing perform in compliance with GMP.

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GC-MS

Gas Chromatography Coupled Mass Spectrometry
Price on request

Microbiology & Quality Associates (MQA) provides analytical testing services for the biotechnology, pharmaceutical, medical device, and other life science industries. We are FDA registered, ISO 17025 accredited, and can perform GMP/GLP testing 7 days a week to provide you with a fast turnaround time. Local sample pickup can also be provided.

Microbiology & Quality Associates (MQA) provides analytical testing services for the biotechnology, pharmaceutical, medical device, and other life science industries. We are FDA registered, ISO 17025 accredited, and can perform GMP/GLP testing 7 days a week to provide you with a fast turnaround time. Local sample pickup can also be provided.

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Gas Chromatography (GC)

Gas Chromatography
Price on request

Microbiology & Quality Associates (MQA) provides analytical testing services for the biotechnology, pharmaceutical, medical device, and other life science industries. We are FDA registered, ISO 17025 accredited, and can perform GMP/GLP testing 7 days a week to provide you with a fast turnaround time. Local sample pickup can also be provided.

Microbiology & Quality Associates (MQA) provides analytical testing services for the biotechnology, pharmaceutical, medical device, and other life science industries. We are FDA registered, ISO 17025 accredited, and can perform GMP/GLP testing 7 days a week to provide you with a fast turnaround time. Local sample pickup can also be provided.

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HPLC

High Performance Liquid Chromatography
Price on request

Microbiology & Quality Associates (MQA) provides analytical testing services for the biotechnology, pharmaceutical, medical device, and other life science industries. We are FDA registered, ISO 17025 accredited, and can perform GMP/GLP testing 7 days a week to provide you with a fast turnaround time. Local sample pickup can also be provided.

Microbiology & Quality Associates (MQA) provides analytical testing services for the biotechnology, pharmaceutical, medical device, and other life science industries. We are FDA registered, ISO 17025 accredited, and can perform GMP/GLP testing 7 days a week to provide you with a fast turnaround time. Local sample pickup can also be provided.

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Mycoplasma Testing

Price on request

Mycoplasma contamination poses a major risk for bioprocess manufacturing. Worldwide regulatory agencies require that all medicines using animal based cell lines must screen the cell line and product harvest for mycoplasma. Detection is performed by direct culture, indirect culture, touchdown PCR, and/or ABI MycoSeq RT-PCR... Show more »

Mycoplasma contamination poses a major risk for bioprocess manufacturing. Worldwide regulatory agencies require that all medicines using animal based cell lines must screen the cell line and product harvest for mycoplasma. Detection is performed by direct culture, indirect culture, touchdown PCR, and/or ABI MycoSeq RT-PCR mycoplasma detection assays. All of the assays are validated to comply with regulatory agency requirements. We can customize your studies to meet EPA, FDA, and EU requirements. MQA is FDA registered and inspected for GMP testing services, and offers services 7 days a week.

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Antimicrobial Activity Testing

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MQA provides a comprehensive program for evaluation of antimicrobial properties of compounds, textiles, liquid or solid materials.

MQA provides a comprehensive program for evaluation of antimicrobial properties of compounds, textiles, liquid or solid materials.

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Molecular Cloning

Price on request

MQA’s Molecular Cloning Services Include:
-Custom vector construction and cloning genes (full-length cDNA) from total RNA or cDNA library, PCR product, oligos/adapters, microDNA or RNA
-Sub-cloning
-Vector Expression Optimization
-Expression Cloning with Retroviral Vectors
-Plasmid Amplification and Isolation Plasmid DNA... Show more »

MQA’s Molecular Cloning Services Include:
-Custom vector construction and cloning genes (full-length cDNA) from total RNA or cDNA library, PCR product, oligos/adapters, microDNA or RNA
-Sub-cloning
-Vector Expression Optimization
-Expression Cloning with Retroviral Vectors
-Plasmid Amplification and Isolation Plasmid DNA preparation services have a flexible scale from MidiPrep (100 μg) up to gram level
-Research Grade: For typical molecular biology research
-Endotoxin Free Grade: Recommended for effective cell transfection, gene vaccine and protein manufacturing, and animal studies

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Bicinchoninic Acid Assay

Price on request

Please contact MQA for more information regarding this service.

Please contact MQA for more information regarding this service.

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Bradford Assay

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Absorbance assay at 280 nm or other wavelength for protein samples

Absorbance assay at 280 nm or other for protein samples. MQA can validate the assay for GMP use. Client must provide reference standard. Assay is performed using a calibrated and validated instrument.

Absorbance assay at 280 nm or other wavelength for protein samples

Absorbance assay at 280 nm or other for protein samples. MQA can validate the assay for GMP use. Client must provide reference standard. Assay is performed using a calibrated and validated instrument.

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Disinfectant Testing

Price on request

Disinfectant efficacy studies are performed to evaluate disinfectant against bacteria, fungi, viruses or spores. Studies are performed to meet FDA, EPA, EU or your company requirements. Contact MQA to design your studies.

Disinfectant efficacy studies are performed to evaluate disinfectant against bacteria, fungi, viruses or spores. Studies are performed to meet FDA, EPA, EU or your company requirements. Contact MQA to design your studies.

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Minimum Inhibitory Concentration (MIC) Assay

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The MIC is the lowest concentration of the antibiotic or antimicrobial agent that results in inhibition of visible growth (i.e. colonies on a plate or turbidity in broth culture) under standard conditions. MQA can perform this assay for your compound against a large battery of pathogen.

The MIC is the lowest concentration of the antibiotic or antimicrobial agent that results in inhibition of visible growth (i.e. colonies on a plate or turbidity in broth culture) under standard conditions. MQA can perform this assay for your compound against a large battery of pathogen.

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Sterility Testing

Price on request

MQA performs sterility testing per USP or EU pharmacopeia. Testing is performed in an ISO 5 BSC located in an ISO 7 room.

Bacteriostasis and fungistasis testing

Bacteriostasis and fungistasis testing is required by all major pharmacopeias as a means of validating the Sterility Test. This essential step should be... Show more »

MQA performs sterility testing per USP or EU pharmacopeia. Testing is performed in an ISO 5 BSC located in an ISO 7 room.

Bacteriostasis and fungistasis testing

Bacteriostasis and fungistasis testing is required by all major pharmacopeias as a means of validating the Sterility Test. This essential step should be conducted on all new products or materials initially submitted for testing and should be repeated periodically to assure continued compatibility with established testing procedures or if the product formulation changes.

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Bioburden Testing

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The microbial enumeration method is a procedure to determine the number of viable microorganisms that are extracted from the product being tested. The method is performed per USP <61> or custom for your particular product. The test is performed for any kind of material and for research use or GMP.

USP <62> selective pathogen... Show more »

The microbial enumeration method is a procedure to determine the number of viable microorganisms that are extracted from the product being tested. The method is performed per USP <61> or custom for your particular product. The test is performed for any kind of material and for research use or GMP.

USP <62> selective pathogen organisms screening: E. coli, Pseudomonas aeruginosa, Salmonella, Candida, Staph. aureus and fungi

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Antimicrobial Efficacy Testing

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We can perform the AET test for pharmaceutical, biological products or cosmetics. The test can be performed to comply with USP and EU requirements. The assay will be customized for your product.

We can perform the AET test for pharmaceutical, biological products or cosmetics. The test can be performed to comply with USP and EU requirements. The assay will be customized for your product.

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pH Measurement

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pH test for water or product. Test performed per USP <791> for R&D, GLP or GMP.

pH test for water or product. Test performed per USP <791> for R&D, GLP or GMP.

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Product Appearance Test

Price on request

Microbiology & Quality Associates (MQA) provides analytical testing services for the biotechnology, pharmaceutical, medical device, and other life science industries. We are FDA registered, ISO 17025 accredited, and can perform GMP/GLP testing 7 days a week to provide you with a fast turnaround time. Local sample pickup can also... Show more »

Microbiology & Quality Associates (MQA) provides analytical testing services for the biotechnology, pharmaceutical, medical device, and other life science industries. We are FDA registered, ISO 17025 accredited, and can perform GMP/GLP testing 7 days a week to provide you with a fast turnaround time. Local sample pickup can also be provided.

Appearance of Solution test is performed per current USP for materials. Test performed in compliance with GMP.

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Microbial Limit Testing

Price on request

The Microbial Limits Test (or Microbial Enumeration Test) is designed to perform the qualitative and quantitative estimations of specific viable microorganisms present in samples. It includes tests for total viable count (bacteria and fungi) and screening for pathogenic organisms such as Staphylococcus aureus, Pseudomonas... Show more »

The Microbial Limits Test (or Microbial Enumeration Test) is designed to perform the qualitative and quantitative estimations of specific viable microorganisms present in samples. It includes tests for total viable count (bacteria and fungi) and screening for pathogenic organisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella, Clostridium, and Escherichia coli. The type of pathogen screening will depend on the product (e.g., oral products are typically tested for absence of E. coli and Salmonella). When test samples have antimicrobial activity or when they include antimicrobial substances, these antimicrobial properties are eliminated by dilution, filtration, neutralization, inactivation, or other appropriate means.

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Calibration Services

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Calibration Capabilities:

MQA technicians have extensive experience in calibrating instruments found in the biotech, pharmaceutical and medical device environments, both on-site at your facility and at our calibration laboratory. See below for a partial list of our capabilities. Please call if you have a need not reflected in... Show more »

Calibration Capabilities:

MQA technicians have extensive experience in calibrating instruments found in the biotech, pharmaceutical and medical device environments, both on-site at your facility and at our calibration laboratory. See below for a partial list of our capabilities. Please call if you have a need not reflected in the list, as our capabilities are continually expanding.

Instruments Serviced:
Pipettes
Spectrophotometers
pH meters
Conductivity meters
Stopwatches/Timers
Controlled temperature environments: refrigerators, freezers, cold rooms, incubators, ovens, rooms, waterbaths, thermometers, and associated chart recorders/data loggers
CO2 instruments
Pressure gauges
Autoclaves (Temperature, pressure, and time)
Centrifuges (speed, temperature, and time)
Temperature indicating systems
Analytical and top-loader balances

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Cleaning Validation Services

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Microbiology & Quality Associates (MQA) provides comprehensive cleaning validation and monitoring services 7 days a week to provide you with a fast turnaround time. We have experienced sampling personnel and can provide sample pick-up within the San Francisco Bay Area. MQA is a local FDA registered GMP laboratory, and is ISO 9001... Show more »

Microbiology & Quality Associates (MQA) provides comprehensive cleaning validation and monitoring services 7 days a week to provide you with a fast turnaround time. We have experienced sampling personnel and can provide sample pick-up within the San Francisco Bay Area. MQA is a local FDA registered GMP laboratory, and is ISO 9001 compliant and ISO 17025 accredited by the American Association for Laboratory Accreditation (A2LA).

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Clean Room Testing and Certification

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MQA provides clean room certification and environmental monitoring (EM) services for clean rooms and other environments in compliance with applicable standards such as ISO, USP, EU, and FDA. We are a GMP FDA registered laboratory, are ISO 17025 accredited, and ISO 9001 compliant. We have more than 25 years of experience in clean... Show more »

MQA provides clean room certification and environmental monitoring (EM) services for clean rooms and other environments in compliance with applicable standards such as ISO, USP, EU, and FDA. We are a GMP FDA registered laboratory, are ISO 17025 accredited, and ISO 9001 compliant. We have more than 25 years of experience in clean room and environmental monitoring testing, and have flexible services available 7 days a week. Sample pick-up and delivery is available in the SF Bay Area for a reasonable fee as well.

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Leak Testing

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A container closure system refers to the sum of packaging components that together contain and protect the drug dosage form. Regulatory agencies require that companies must demonstrate that the container closure system used to package a drug or medical device will protect the product from microbial contamination or preserve the... Show more »

A container closure system refers to the sum of packaging components that together contain and protect the drug dosage form. Regulatory agencies require that companies must demonstrate that the container closure system used to package a drug or medical device will protect the product from microbial contamination or preserve the sterility for the life of the product. The product container closure system can be tested by physical (Dye Leak test) or microbiological means (microbial immersion test).

The dye leak test is performed by immersing the samples in a vacuum chamber filled with methylene blue dye. After exposure to the dye and test conditions, the samples are inspected for the presence of the dye.
The microbial challenge test is performed by immersing the simulated samples filled with Tryptic Soy broth in a media broth inoculated with B. diminuta. The samples are incubated for 14 days at 30-35°C and then inspected for contamination.

Typically, the test is performed using the same number of samples as the sterility test, plus positive and negative controls.

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Bioproduct Safety Testing

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Microbiology & Quality Associates (MQA) offers safety testing for biotechnology products derived from cell lines derived from human of animal origin. We offer flexible services 7 days a week to help you meet your deadlines. We offer testing for working cell banks, master cell banks, Cells at the Limit of in vitro Cell Age or End of Production Cells, Unprocessed Bulk, and Final Filled Product.

Microbiology & Quality Associates (MQA) offers safety testing for biotechnology products derived from cell lines derived from human of animal origin. We offer flexible services 7 days a week to help you meet your deadlines. We offer testing for working cell banks, master cell banks, Cells at the Limit of in vitro Cell Age or End of Production Cells, Unprocessed Bulk, and Final Filled Product.

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Primary Cell Line Generation

Price on request

Primary cells are cells straight from the tissue with no passages. A primary cell culture may be composed of mixtures of cell types. Frequently, some of the cells may survive without proliferating, and will therefore be lost in the increasing population of those which are able to multiply in the conditions supplied in... Show more »

Primary cells are cells straight from the tissue with no passages. A primary cell culture may be composed of mixtures of cell types. Frequently, some of the cells may survive without proliferating, and will therefore be lost in the increasing population of those which are able to multiply in the conditions supplied in vitro.

Cells from explants may sometimes be converted to cell lines by passage. These may continue to proliferate for a number of cell generations.

MQA also offers cells for use of primary fibroblasts as feeder layers for the growth of some embryonic stem cell types. At MQA, our scientists can prepare primary cell lines from most tissues using our standard protocols. If you would like to implement a custom project, we would be happy to discuss your project specifications with you.

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Cell Line Authentication

Price on request

One of the major problems in cell culturing is the misidentification or cross-contamination of authentic continuous cell lines. Confirmation of purity and identity of cell cultures is a necessary step in the production of biotherapeutics. Working with several cell lines in the same facility can result in cross contamination while... Show more »

One of the major problems in cell culturing is the misidentification or cross-contamination of authentic continuous cell lines. Confirmation of purity and identity of cell cultures is a necessary step in the production of biotherapeutics. Working with several cell lines in the same facility can result in cross contamination while mislabeling of cultures can cause misidentification. The method is based on the isoelectric separation of a specific set of intracellular enzymes which can be used to distinguish between human, murine, or other mammalian cell lines.

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Cell Proliferation Assays

Price on request

Testing by MTT, XTT, or any customized approach, such as Alamar blue, is based on the ability of metabolically active cells to convert special dyes into measurable flurophores such as yellow tetrazolium salt, XTT, into orange formasan. Complex rinsing is thus avoided, which is necessary, for example, in the older MTT method. ... Show more »

Testing by MTT, XTT, or any customized approach, such as Alamar blue, is based on the ability of metabolically active cells to convert special dyes into measurable flurophores such as yellow tetrazolium salt, XTT, into orange formasan. Complex rinsing is thus avoided, which is necessary, for example, in the older MTT method. This guarantees high accuracy of the XTT test and allows for fast processing of the data obtained. The bioassay may also be used to establish relative, cytotoxicity of agents within various chemical classes. We can establish baseline data for predicting the toxicity of related novel agents by comparing such baseline data with known in vivo toxicity. The assay is simple to perform since the indicator is water soluble, thus eliminating the washing/fixing and extraction steps required in other commonly used cell proliferation assays.

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Particulate Analysis

Price on request

Parenteral drugs administered by injection to patients should be essentially free of visible particles. Sub-visible particles in parenteral drugs are detected using a light obscuration particle counter, microscopic inspection on a filter, or both.

Microbiology & Quality Associates (MQA) can provide Particulate Analysis per USP... Show more »

Parenteral drugs administered by injection to patients should be essentially free of visible particles. Sub-visible particles in parenteral drugs are detected using a light obscuration particle counter, microscopic inspection on a filter, or both.

Microbiology & Quality Associates (MQA) can provide Particulate Analysis per USP <788>. There are two methods for the determination of particulate matter:

Method 1: Light Obscuration Particle Count Test
Method 2: Microscopic Particle Count Test
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Equipment Validation

Price on request

Microbiology & Quality Associates (MQA) provides validation support services to the Pharmaceutical, Biotechnology, Medical Device, and Nutritional Product companies. Meeting FDA qualification requirements requires the expertise and experience that our staff can provide, and we are dedicated to working with you to put a package... Show more »

Microbiology & Quality Associates (MQA) provides validation support services to the Pharmaceutical, Biotechnology, Medical Device, and Nutritional Product companies. Meeting FDA qualification requirements requires the expertise and experience that our staff can provide, and we are dedicated to working with you to put a package together that meets your budget and timelines. We would be happy to evaluate your site to provide you with a complimentary assessment of your project needs.

Autoclave validation
Chemical sterilization cycle development, D value and Z value determinations
Cleaning Validation
Clean Room Validation (IQ, OQ, PQ)
Clean Room, BSC, & Fume Hood Certification Services
Utility System Validation
Filter Microbial Validation
Lab Equipment Validation
Method Qualification and Validation per USP and ICH
Process Validation Support
Dry Heat Oven Validation
Validation of Incubators, Freezers, Refrigerators, Stability Chambers, and LN2 Storage
Virus and Microbial Inactivation Studies

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Biology

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Spectroscopy

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Cell-Based Assays

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Cell Lines

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Product Quality Control

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DNA Services

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Mammalian Cell Culture

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Separation/Purification Services

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Mass Spectrometry

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Pharmacology & Toxicology

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Equipment Maintenance and Support

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Analytical Chemistry Services

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Cells and Tissues

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Product Testing Services

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Protein Quantification

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Chemistry and Materials

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Protein Services

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Chromatography

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Laboratory Equipment and Facility Management Services

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Imaging & Spectroscopy

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Liquid Chromatography (LC)

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Primary Cell Culture

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Other Mass Spectrometry Methods

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Cell Invasion & Migration Assays

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Product Development, Testing, and Packaging

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Toxicology

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Equipment

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Nucleic Acid Services

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Angiogenesis & Endothelial Cell Assays

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Testing of Cell Lines

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Cell Death Assays

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In vitro Toxicity Testing

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Sterilization Services

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Biochemistry & Molecular Biology

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Microbiology

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Cell Viability & Proliferation Assays

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