BioScreen Pharmaceutical Services, Inc.
3904 Del Amo Blvd. No. 801
Torrance, CA 90503
T: (310) 214-0043     F: (310) 370-3642
W: www.bioscreen.com

BioScreen Pharmaceutical Services is a full service GMP contract laboratory specializing in Analytical Chemistry, Microbiology, and Stability services.  BioScreen is an ideal partner for R&D phase I-III, as well as GLP and GMP studies.  All testing conforms to ISO 9001:2008.  BioScreen is DEA Registered for handling class II-V controlled substances.

Analytical Chemistry

BioScreen has over 20 years of analytical experience.  Specializing in method development and validation for in HPLC, GC, GC-MS, ICP and ICP-MS. All validation packages are delivered to the client ready for FDA review or submission.

Pharmacopoeia Testing per USP, EP, BP, JP, FCC, ACS, AOAC, and Other Monographs

Active Pharmaceutical Ingredient (API) – Drug Substance

Excipient

Bulk Release

Drug Product/ Finished Product

Water Testing

Total Organic Carbon Determination, TOC USP, EP (2.2.44)

Conductivity Measurement, USP

Heavy Metals Testing, USP

Elemental Impurities – Limits, USP

Elemental Impurities – Procedures, USP

Cleaning Validation Studies

Leachables & Extractables, USP, EP (3.2.2)

Residual Solvents, USP

Container Closure Integrity/Dye Immersion

Content Uniformity

Dissolution Testing, USP

Physical Testing

Stability

Long- & Short-Term Stability

Drug Substance or Drug Product Stability

IND, NDA, ANDA Stability

Protocol Design for R&D Stability

Stability Storage

Ultra Low Freezer at -84°C to -66°C

Freezer at -20°C to -10°C

Freezer at -25°C to -15°C

Refrigerated at 2°C to 8°C

25°C ± 2°C with Ambient Humidity

25°C ± 2°C with 60% ± 5% Relative Humidity

30°C ± 2°C with 65% ± 5% Relative Humidity

Accelerated at 40°C ± 2°C Ambient Humidity

Accelerated at 40°C ± 2°C, 75% ± 5% RH

Accelerated at 45°C ± 2°C Ambient Humidity

Accelerated at 50°C ± 2°C Ambient Humidity

Ultra-Low Freezer at -84° to -66°C

Freezer at -20° to -10°C

Freezer at -25° to -15°C

Refrigerated at 2° to 8°C

Photostability Chamber

Custom Conditions Available on Request

Microbiology Services

BioScreen has 30 years of experience in microbiology testing for pharmaceutical, biotechnology, and medical devices.

Microbiological Examination of Nonsterile Products: MLT per USP and, BP/EP, JP, US

Antimicrobial Effectiveness Tests: USP, EP, JP, ISO
Minimum Inhibitory Concentration

Bacterial Endotoxin Tests: USP, BP/EP

-Gel Clot

-Kinetic

Chromogenic

Turbidimetric

Sterility Test: BP/EP, USP

-Direct Immersion

-Bacteriostasis/Fungistasis

-Membrane Filtration

Close (Steri Test)

Open

Particulate Matter USP , BP/EP

-Light Obscuration

-Microscopic

Container Closure Study (Microbial Ingress)

AMES Test (Mutagencity Test)

-OECD # 471

Susceptibility Tests

-Minimum Bactericidal Concentration (MBC)

-Log Reduction (Time Kill Study)

Heterotrophic Plate Count

Microorganism Identification

-Vitek

-Analytical Profile Index (API)

-DNA