Project Description
FDA cGMP Pharmaceutical analytical chemistry laboratory needed for identity testing for the following drug and excipient materials that may be used in production of clinical grade biological drug products:
Pluronic F-68
1X Phosphate Buffer Saline
L-Glutamine
Plasmids
F-17 Serum Free Media
CDM4HEK293 Media
Sterile water WFI
Clinical 293 Suspension Cell Bank
Polyethylenimine (PEI) Max.
MW 25,00010X Phosphate Buffer Saline
1M Tris, pH 9.0
Tris(hydroxtmethyl) aminomethane
1M Tris-HCl, pH 8.0
10mM Tris, pH 8.0
1X Phosphate Buffer Saline
5M Sodium Chloride Solution
Benzonase® endonuclease, purity grade I (?99%)
Hydrochloric acid solution 6N
Optiprep
Phenol Red
Sodium hydroxide solution 0.5N
Sorbitol
Sterile WFI Water
1M Magnesium Chloride
Ethyl Alcohol 200 Proof
Project Information
Number:16-01352
Other pharmaceuticals and biopharmaceuticals laboratory services.
Other Pharmaceuticals and Biopharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :
- Drug Discovery Testing
- Drug Development Testing
- Non-Clinical Study Testing
- Preclinical Study Testing
- Clinical Trials Testing
- Pharmacokinetics (PK) Testing
- Pharmacodynamics (PD) Testing
- ADME Testing
- Sterility Testing
- Pyrogens Testing
- Endotoxins Testing
- Raw Material Testing
- Finished Product Quality Control Release Testing
- Real-Time Stability Testing
- Accelerated Stability Testing
- Method Development Testing
- Method Validation Testing
- Drug Release/Dissolution Testing
- Extractable Testing
- Leachable Testing
- Elemental Impurities Testing
- Packaging Testing
- Child-Resistant Packaging Testing
- Container Closure Integrity Testing (CCIT) Testing
- High Throughput Screening Testing
- Reverse Pharmacology Testing
- Excipients Testing
- Active Pharmaceutical Ingredient API Testing
- Toxicology Testing
- Toxicity Testing
- Microbiology Testing
- Strength Testing
- Quality Testing
- Purity Testing
- Consistency Testing
- Acid Insolubles Testing
- Acid Solubles Testing
- Alkali Solubles Testing
- Alkalinity Testing
- Appearance Testing
- Boiling Point Testing
- Congealing Temperature Testing
- Flash Point Testing
- Melting Point Testing
- Freezing Point Testing
- Hardness Testing
- Heat of Combustion Testing
- Preservatives Testing
- Loss on Drying (under Vacuum) Testing
- Loss on Ignition Testing
- Melting Point Testing
- Mineral Analysis Testing
- Non-aqueous Titration Testing
- Normality Testing
- Organic Acids Testing
- Organic Extractives Testing
- Oxidizing Substances Testing
- Peroxide Value Testing
- Pour Point Testing
- Reactivity Testing
- Reactivity to Water Testing
- Reducing Substances Testing
- Refractive Index Testing
- Residue on Evaporation Testing
- Residue on Ignition Testing
- Saponification Value Testing
- Sieve Analysis Testing
- Silver Reducing Substances Testing
- Silicon Testing
- Sulfur Testing
- Sodium Testing
- Specific Gravity Testing
- Specific Rotation Testing
- Sugars Testing
- Sulfur Compounds Testing
- Surfactants Testing
- Talc Testing
- Titration Curve Testing
- Total Halides Testing
- Total Reducing Compounds Testing
- Unburned Carbon Testing
- Uncarbonized Constituents Testing
- Unsaponifiable Matter Testing
- UV Absorption Testing
- Volatile Matter Testing
- Volatile Suspended Solids Testing
- Weight Variation Testing
- Cytotoxicity Testing
- Elution Testing
- Agar Diffusion Testing
- Bioburden Testing
- Antimicrobial Effectiveness Testing
- Particulates Testing
- Total Combined Mold & Yeast (TYMC) Testing
- Total Aerobic Microbial Count (TAMC) Testing
- Testing
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