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Biotech Contract Development Services

Testing services by Industry:

Pharmaceutical and Biotechnology Companies

• Environmental monitoring

  		Clean Room Sampling
  		Sampling Surfaces Personnel Air viable and non-viable particulates
  		Compressed Gases
  		Sampling Non-viable Bioburden (viable particulates) Oil vapor Moisture
  		Clean Steam
  		Sampling TOC LAL endotoxin Bioburden Conductivity tests
  		Clean room validation

• Microbiology

  		Antimicrobial Effectiveness Test (USP or EP)
  		Antimicrobial Properties Material Evaluation
  		Bacteria Characterization with RiboPrinter
  		Bioburden Test for In-process or bulk samples (USP, EP or other methods)
  		Biological Indicator Processing and Qualification
  		Disinfectant & Sporicidal Qualification Studies
  		AOAC Use Dilution Test Kill Time studies Fungicidal Activity Tests AOAC Germicidal Spray Products Test Use-dilution studies using coupons In-house organisms efficacy studies Custom Disinfectant Efficacy Studies

Pharmaceutical and Biotechnology Companies

• Analytical Testing

  		Cell bank preparation and storage - research or GLP
  		Cell culture media growth promotion
  		USP cytotoxicity assay
  		Cytotoxicity using different cell lines
  		Cell based bioassays
  		ELISA
  		Host cell residual DNA
  		Host cell protein analysis
  		Isoenzyme cell identity assay
  		LAL - endotoxin
  		Mycoplasma screening by PCR
  		Immunoblotting
  		pH
  		SDS-PAGE (R) & SDS-PAGE (NR)
  		Sterility testing of cell banks

• Cleaning validation Support

  		Sampling
  		Testing
  		TOC LAL endotoxin Bioburden Conductivity tests pH

• Package Integrity Testing

  		Microbial immersion test
  		Dye leak test

• Product testing

  		Appearance
  		A280
  		Appearance
  		Bacteriostasis and Fungistasis for Sterility test
  		Bioburden
  		Endotoxin
  		Bacteriostasis and Fungistasis test for sterility test
  		Conductivity
  		pH
  		USP <788> Particulate Matter in Injection
  		Sterility (GLP only)
  		SDS-PAGE (R) & SDS-PAGE (NR)

• * Protein characterization

  		Mass Spec.
  		HPLC
  		Extinction coefficient determination
  		Protein identity
  		Quantitative analysis HPLC (size exclusion, reverse phase, peptide mapping)
  		Isoelectric point determination.
  	*Note: some of the testing maybe performed by local partner analytical labs.

• Water Chemical Testing

  		Chlorine
  		Conductivity
  		Iron
  		Phosphate
  		Sodium
  		Copper
  		Hardness
  		Heavy Metals
  		Nitrates
  		Total Organic Carbon
  		Total Dissolved Solids
  		Total Suspended Solid (TDS)

Medical Device Companies

• Biological indicator sterility test (Steam, Radiation, Dry heat & ETO)

• Bioburden studies (AAMI and UPS)

• Clean room sampling and validation

  		Sampling
  		Surfaces
  		Personnel
  		Air viable particulate
  		Non-viable particulate

• Endotoxin testing by LAL method (Gel-Clot, Kinetic Turbidimetric and Kinetic Chromogenic)

• Gamma and E-Beam irradiation validation (AAMI)

  		Bioburden method development
  		Bioburden recovery studies
  		Bioburden studies for dose setting

• Package Integrity Testing

  		Microbial immersion test
  		Dye leak test

• Water Chemical Testing

  		Chlorine
  		Conductivity
  		Sodium
  		Copper
  		Hardness
  		Heavy Metal
  		Nitrates
  		Total Organic Carbon
  		Total Dissolved and Suspended Solids

Nutritional Supplements

• Method development

• Microbial limit test and Pathogen screening (USP)

• Water Chemical Testing

  		Chlorine
  		Conductivity
  		Sodium
  		Copper
  		Hardness
  		Heavy Metal
  		Nitrates
  		Total Organic Carbon
  		Total Dissolved and Suspended Solids

Cosmetics

• Aerobic plate count (APC)

• Fungi (yeast, and mold) plate count

• Anaerobic plate count (use only for talc's and powders)

• Screening test for total numbers of microorganisms present in used and unused cosmetics.

• Preservative efficacy test

• Pathogen screening

• Water Chemical Testing

  		Chlorine
  		Conductivity
  		Sodium
  		Copper
  		Hardness
  		Heavy Metal
  		Nitrates
  		Total Organic Carbon
  		Total Dissolved and Suspended Solids