ABR

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For over 25 years, ABR has served the global pharmaceutical and biotechnology industries with world-class testing service, careful attention to quality and industry-leading turnaround time. The team of scientists at ABR is dedicated to providing accurate, timely, and precise results, while ensuring a high degree of customer service. ABR continues to design and develop virus detection protocols and other assays to meet evolving needs and changing regulations.

ABR’s virus assays satisfy United States 9th Code of Federal Regulation (9CFR), European Medicines Agency (EMA/EMEA), CVMP and CPMP regulations. Additionally, ABR operates under the principles of Good Laboratory Practice (GLP) as defined in the Twenty-first Code of Federal Regulations (21CFR), Part 58. In order to provide more service for customers, ABR has recently developed assays for mycoplasma by USDA-9CFR requirements as well as species of origin and IgG level tests. More assays and other regulatory compliance methods are under development. ABR also has the capability to customize studies for clients' needs in ever changing regulatory environments.


All Virus Testing
 

• USDA-APHIS 9 CFR assays for detection of adventitious viruses as specified in USDA-APHIS 9 CFR § 113.52, § 113.53c or § 113.55, including § 113.46 and § 113.47. ABR tests for all viruses and species listed in 9 CFR § 113.47. For testing on other origin species or other viruses, please inquire.

• EP/EMA compliant assays for bovine viruses and neutralizing antibodies in bovine serum. ABR’s EMA assays satisfy European specifications as defined in:

• EMA/CHMP/BWP/457920/2012 rev 1 (2013) 7.3.1, 7.3.2, 7.3.3, 7.3.4

• EMA/CVMP/743/00-Rev.2 (2005) 4.3.3.1, 4.3.3.2

• EMA/CPMP/BWP/1793/02 (2003) 5.3.1, 5.3.2, 5.3.3

• European Pharmacopoeia 5.2.5 (07/2009:50205)

• General Requirements for Inactivated (7Blm2a) and Live (7Blm1a) Vaccines for Veterinary use

• Modified EMA and 9 CFR procedure assays for Bovine, Canine, Equine, Feline, Lapine, Murine, and Porcine Viruses.

• Serology, including IFA, alpha SNs (serum neutralizations) and beta SNs

• Virus screening assays for common viruses like BVDV

• Custom testing: ABR offers a variety of custom tests. Please feel free to contact us to discuss your testing needs so that we can design a custom study that will meet your requirement.

• Mycoplasma assays as specified in USDA-APHIS 9 CFR § 113.52 and § 113.53a or § 113.28. An inhibition assay is also available. Minimum testing time is 29 days.

• Sterility assays as specified in USDA-APHIS 9 CFR § 113.26 and § 113.27. Minimum testing time is 14 days.

• Bovine

• Canine

• Equine

• Feline

• Hamster

• Porcine

Regulatory compliance testing for adventitious viruses in animal origin products, virus seeds and cell stocks used in the pharmaceutical and biotechnology industries.

ABR performs regulatory compliance testing for mycoplasma, bacteria and fungi in a variety of materials used in the pharmaceutical and biotechnology industries.

Materials Tested:

Material Tested:

9C-CL-ID eva1uates the test article cells using antispecies cell fluorchrome-conjugated antibody to determine if the cells are of the species of origin expected. The assay is designed to fulfill the requirement of USDA 9 CFR § 113.52b.

Cell Species Identified:

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