Residual Protein A

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).

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 circulat...

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 dissolut...

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

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

ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.

USP / NF (United States Pharmacopeia) testingEP (European Pharmacopeia) testing
JP (Japanese Pharmacopeia) testing

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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...

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

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

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.

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

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