Pharmaceuticals

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ARL provides full laboratory services for pharmaceutical and biotechnology companies. Laboratory services include testing for New Drug Application (NDA), Abbreviated New Drug Application (ANDA), medical devices (510K) and over-the-counter products.

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Services Offered:

Stability Studies

A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).

Compatibility Studies

Also known as y-site studies, compatibility testing is performed to ensure that the mixing of two different formulations does not impact the physical or chemical properties of the drugs.

Raw Material Testing

Dissolution Testing

Quality tests to ensure proper performance of the formulation, generally solid oral dose forms such as tablets and capsules.

Microbial Identification

This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.

PK/PD Studies

A PK/PD study analyzes the rate and extent of absorption of the active ingredient or moiety and emphasizes the use of pharmacokinetic endpoints in an accessible biological matrix, such as blood, plasma, and/or serum, to indicate release of the drug substance from the drug product into the systemic circulation.

Pre-Clinical and Clinical Analytical Testing

ARL Bio Pharma has extensive experience with chemical, manufacturing and controls testing for original and abbreviated new drug applications. This testing includes: identification tests, quantitative tests for impurities content, limit tests for the control of impurities, performance tests such as dissolution/disintegration and quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product.

Chinese Hamster Ovary Host Cell Protein Testing

ELISA methods are used to test for the presence of residual host cell proteins left in a drug or therapeutic protein following purification.

E. Coli Host Cell Proteins

ELISA methods are used to test for the presence of residual host cell proteins left in a drug or therapeutic protein following purification. 

Residual Protein A

ELISA methods are used to test for the presence of residual proteins left in a drug or therapeutic protein following purification.

Protein Aggregation

This test detects and quantifies impurity particles in a drug or therapeutic protein.

Protein Content

This test quantitates the total protein in pharmaceutical drug or therapeutic protein and products.

Biological Activity

This test provides a direct measure of the effectiveness of the active ingredient.

Extractable Volume

Each container of an injection contains sufficient excess to allow withdrawal of the labeled quantity of drug.  This test allows measurement to verify withdrawal and administration of the labeled volumes.

Osmolarity

Osmolarity is a theoretical quantity that is calculated from the experimentally measured value of osmolality and the density of the solution. The units of osmolarity are osmole per liter of solution (Osmol/L) or milliosmole per liter of solution (mOsmol/L).

Osmolality

Osmolality measures the concentration of a solution expressed as the total number of solute particles per kilogram of water.  The units of osmolality are osmole per kilogram of water (Osmol/kg) or milliosmole per kilogram of water (mOsmol/kg).

All services provided will adhere to ARL Bio Pharma’s terms and conditions