ARL Bio Pharma
About ARL Bio Pharma
Certifications
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FDA -
GMP -
ISO
Categories
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US -
2019On CPHI since
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3Certificates
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100 - 249Employees
Company types
Contact info
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Meet us at
CPHI Americas 2025
Pennsylvania Convention Center, Philadelphia
20 May 2025 - 22 May 2025
Products from ARL Bio Pharma (15)
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Product Biological Activity
This test provides a direct measure of the effectiveness of the active ingredient. -
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. -
Product 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. -
Product Dissolution Testing
Quality tests to ensure proper performance of the formulation, generally solid oral dose forms such as tablets and capsules. -
Product 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. -
Product 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. -
Product 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). -
Product 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). -
Product 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 circulat... -
Product 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 dissolut... -
Product Protein Aggregation
This test detects and quantifies impurity particles in a drug or therapeutic protein. -
Product Protein Content
This test quantitates the total protein in pharmaceutical drug or therapeutic protein and products.
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