Testing ServicesRaw Materials, Cell Banks/Stocks and Virus Banks/Product Lots

Integrity

VMRD entered the regulatory testing business in the process of satisfying our own testing needs to support USDA CVB licensing of our veterinary diagnostic products. In keeping with our company values of doing to others as we would have them do to us, we test your samples with the same care and diligence that we apply to our own samples. We understand the tension that you face: you want results quickly so that you can sell your product, but you also need to make sure that your product is free of adventitious agents and that the regulatory testing requirements have been satisfied. We keep both things in mind as we work with your sample and are constantly improving our ability to give you accurate results rapidly. Our goal is to remove as much hassle as possible from your regulatory compliance testing so that you can focus on selling your product. If you ever have any dissatisfaction with our services, I encourage you to contact me personally.

Soli Deo gloria,

Ethan Adams, CEO

Quality

VMRD testing services are performed by highly qualified staff who have extensive laboratory experience. Our background in veterinary diagnostics manufacturing gives us unique insights into the cell culture systems and reagents used to perform our testing that allow us to provide superior testing. We have also invested in a quality management system that encompasses all aspects of our testing services and we welcome vendor audits as we find they help us refine our quality practices.

Experience

Through more than 34 years of experience testing and reporting, we have optimized and refined our testing methods, bench records, and reporting for maximum accuracy and acceptability to regulatory officials. We bring additional unique value to satisfying USDA CVB testing requirements based on our experience licensing more than a dozen diagnostic products.

Convenience

Our assay offerings are geared toward providing one-stop testing for regulatory compliance saving you time and money. Sample submission, test selection, and result reporting are facilitated through a secure online portal providing easy, self-service access to present and past test results. Our dedicated Customer Experience Center (CEC) personnel are always available to assist with any inquiries and our study directors are glad to consult on any technical matters just as soon as they can break away from their work in the lab.

Raw Materials Testing

VMRD currently tests for viruses in materials from several mammalian species. These include testing of serum and other materials with bovine, equine and porcine origin that are used to manufacture human and/or veterinary medicinal products. Some of our most tested products include Fetal Bovine Serum, BSA, Edamin-F, Trypsin and Protease-Peptone.

Cell Line Testing (Cell Banks/Stocks)

Testing of cell lines and cell banks is required per several regulations and VMRD offers tests to meet regulations for different end uses. Species tested include: bovine, porcine, canine, equine, and feline.

Virus Banks/Product Lots

Virus banks or viral products require evaluation for extraneous viruses as specified in different regulations. This is a requirement for viral bank characterization programs and viral product lot release programs. Virus products that are toxic, replication competent, or capable of infecting an indicator cell lines may require modifications to the standard protocols.

VMRD Testing Services offers several validated assays to evaluate a wide range of test articles for extraneous viruses as specified in several guidance documents including:

• USDA-APHIS 9 CFR• European Medicines Agency (EMA) and European Pharmacopeia (EP) • USP monographs

Additionally:

• Virus inactivation validations • Other In vitro virology custom assays

VMRD Scientists can assist you in identifying testing specific to your material and its final destination.

Virus

Raw materials TestingASSAY DESCRIPTION CATALOG # MATERIALS TESTED REGULATION SATISFIED VOLUME ASSAY TIMEBovine virus testing on primary bovine cells 9C-AOP-BOV Bovine (B): Serum, powder 9 CFR 113.46 113.47 113.53c+* 100ml/2g 22 days

Porcine virus testing on porcine cells 9C-AOP-POR Porcine (P): Serum, powder 9 CFR 113.46 113.47 113.53c* 100ml/2g 22 days

Equine virus testing on equine cells 9C-AOP-EQU Equine (E): Serum, powder 9 CFR 113.46 113.47 113.53c* 100ml/2g 22 days

Virus testing on (VERO) African green monkey kidney cells 9C-AOP-VERO (B)(P)(E): Serum, powder 9 CFR 113.46 113.47 113.53(c)(1) 100ml/2g 22 days

Bovine virus testing on primary bovine cells EM-AOP-BOV Bovine (B): Serum, powder EP 5.2.5 including CVMP, CHMP/BWP 100ml/2g 22 days

Porcine virus testing on porcine cells EM-AOP-POR Porcine (P): Serum, powder EP 5.2.5 100ml/2g 22 days

Equine virus testing on equine cells EM-AOP-EQU Equine (E): Serum, powder EP 5.2.5 100ml/2g 22 days

Virus testing on (Vero) African green monkey kidney cells EM-AOP-VERO (B)(P)(E): Serum, powder EP 5.2.5 100ml/2g 22 days

Testing on PT cells for PPV 9C-PT-POR Porcine Trypsin 9 CFR 11.53(d) 5g/eq lqd 29 days

Testing on primate cells for PRRSV M9C-AOP-MON-PRRSV Porcine Trypsin NA 100ml/10g 22 days

Testing on primate cells for Rotavirus M9C-AOP-MON-ROTA Porcine Trypsin NA 100ml/10g 22 days

Testing on primary bovine cells for a selected viruses M9C-AOP-BOV (B)(P)(E): Serum, powder Partial 9 CFR 113.53c and 113.47 100ml/10g 22 days

Testing on primary bovine and VERO cells for BVDV,IBR,PI3per methods in 9CFR 113.53(c), 113.46 and 113.47 LT-AOP-BOV (B)(P)(E): Serum Partial 9 CFR 113.53c and 113.47 100ml 22 days

Porcine virus testing of equine origin product EM-AOP-POR Equine (E): Serum EP/EMA (CVMP/CHMP) 100ml/10g 22 days

Bovine virus testing of bovine origin products EM-AOP-BOV Bovine (B): Serum EP 100ml/10g 22 days

Comparative Titration/Serum Inhibitory Test EM-CT-AOP-BOV Bovine (B): Serum CPMP/BWP/1793/02 (2003) 5.3.4 100ml/10g 28 days

Quantitative BVD assay test QUANT-AOP-BOV Bovine (B): Serum CVMP/CHMP/CPMP 100ml/10g 7 days

Virus testing on FBLP cells SN-AOP-BOV Bovine (B): Serum EMA/CVMP/CHMP/CPMP 100ml/10g 7 days

Assay to determine if a TA nuetralizes BVD virus VR-AOP-BOV Bovine (B): Serum EMA/CVMP/CHMP/CPMP 100ml/10g 7 days

Constant virus and dilutions of serum to test for BVDV and BVDV-2 VR-AOP-BOV Bovine (B): Serum EMA/CVMP/CHMP/CPMP 100ml/10g 7 days

Quantitative SN assay for BVDV1 ALPHA-AOP-BOV Bovine (B): Serum EMA/CVMP/CHMP/CPMP 100ml/10g 7 days

BPyV Virus Assay on Bovine Cells M9C-AOP-BOV-BPYV Bovine : Serum, powder N/A 100ml/10g 22 days

Senecavirus A assay FA-SVA, M9C-AOP-POR Porcine: Serum, powder N/A 50ml/2g 22 days

+ Viruses tested by FA include: BTV, BAV3, BAV5, BPV, BRSV, BVDV Reovirus, Rabies Virus and optional virus tests : VSV, BLV, IBR/BHV-1, PI-3

*This regulation is satisfied only if tested in combination with 9C-AOP-VERO and other tests related to associated species

DESCRIPTION CATALOG # MATERIALS TESTED REGULATION SATISFIED VOLUME ASSAY TIMEVirus testing on primary bovine cells 9C-CL-BOV Bovine (B): Cell lines Partial 9 CFR 113.52e&f 2x1ml aliquots 36 days

Virus testing on Porcine cells 9C-CL-POR Porcine (P): Cell lines Partial 9 CFR 113.52e&f 2x1ml aliquots 36 days

Virus testing on Equine cells 9C-CL-EQU Equine (E): Cell lines Partial 9 CFR 113.52e&f 2x1ml aliquots 36 days

Virus testing on Feline cells 9C-CL-FEL Feline (F): Cell lines Partial 9 CFR 113.52e&f 2x1ml aliquots 36 days

Virus testing on vero cells 9C-CL-VERO (B)(P)(E)(F): Cell lines Partial 9 CFR 113.52e&f 2x1ml aliquots 36 days

Virus testing of Avian Primary cells 9C-CLP-AVI Avian (A): Cell lines Partial 9 CFR 113.51c 2x1ml aliquots 15 days

DESCRIPTION CATALOG # MATERIALS TESTED REGULATION SATISFIED VOLUME ASSAY TIMEVirus testing on primary bovine cells 9C-MSV-BOV Virus banks Partial 9 CFR 113.55 2x1ml aliquots 15 days

Virus testing on Porcine cells 9C-MSV-POR Virus banks Partial 9 CFR 113.55 2x1ml aliquots 15 days

Virus testing on Canine cells 9C-MSV-CAN Virus banks Partial 9 CFR 113.55 2x1ml aliquots 15 days

Virus testing on VERO cells 9C-MSV-VERO Virus banks 9 CFR 113.55 a(1) 2x1ml aliquots 15 days

Virus testing on MARC cells 9C-MSV-MARC Virus banks Partial 9 CFR 113.55 2x1ml aliquots 15 days

Virus testing of bovine virus seeds EM-MSV-BOV Virus banks EMA/CVMP/IWP 2x1ml aliquots 29 days

Virus testing of canine virus seeds EM-MSV-CAN Virus banks EMA/CVMP/IWP 2x1ml aliquots 29 days

Virus testing of porcine virus seeds EM-MSV-POR Virus banks EMA/CVMP/IWP 2x1ml aliquots 29 days

Cell Lines/Stocks Testing

Viral Banks and Viral Product Lots Testing

Please inquire if your specific testing requirement is not listed above

*This regulation is satisfied only if tested in combination with 9C-CL-VERO and other tests related to associated species

VMRD’s sterility testing includes a bacteriostasis/fungistasis test to assess whether or not the test article inhibits the growth of microorganisms. The performance of bacteriostasis and fungistasis testing is required in order to validate the sterility result and confirm that there are no antimicrobial properties within the test article that would inhibit the detectionof microbial organisms during the assay.

We are also excited to announce that VMRD will be offering sterility testing compliant with USP and EP regulations on bulk or final products by direct inoculation or membrane filtration methods in thenear future.

SterilityVMRD offers bacteria and fungi testing that is compliant with USDA-APHIS 9 CFR (9CFR 113.26 and 113.27c,d)

DESCRIPTION CATALOG # MATERIALS TESTED REGULATION SATISFIED VOLUME ASSAY TIME

Bacteria and Fungi testing 9C-B&F Serum, powder, cell banks/cell lines 9 CFR 113.52d,113.53b 100ml/10g 2 x 1 ml aliquots 14 days

Bacteria and Fungi testing 9C-B&F-MSV Virus banks/viral product lots 9 CFR 113.27c,d, SAM 908 2 x 1 ml aliquots 14 days

Bacteria and Fungi testing by membrane filtration COMING SOON Serum, powder, virus banks/viral product lots EP 2.6.1/USP <71> TBD 14 days

VMRD offers mycoplasma assays to satisfy various regulations, including:

• USDA-APHIS 9CFR (9CFR 113.52c,113.53a using methods described in 113.28)

• European Pharmacopeia (EP), European Medicinal Agency (EMA) (EP 2.6.7, EMA)

• United States Pharmacopeia (USP <63>)

Additionally:

• Large Volume Barile method mycoplasma detection assays - broth and agar method and indirect indirect cell culture method

Each assay has been validated or verified to provide the best possible sensitivity for the detection of Mollicutes in your test article. The EP mycoplasma testing includes an inhibition assay (substrate qualification) to evaluate the test article for inhibition of mycoplasma growth as per EP 2.6.7 & USP <63> regulations and has been validated with seven different Mollicutes strains.

Mycoplasma

DESCRIPTION CATALOG # MATERIALS TESTED REGULATION SATISFIED VOLUME ASSAY

Mycoplasma Detection 9C-MY Serum, powder, cell lines/stocks, virus banks/lots 9CFR 113.52c,113.53a 10ml/1g/

2 x 1 ml aliquots 28 days

Mycoplasma Detection with Inhibition 9C-MY-IN Serum, powder, cell lines/stocks, virus banks/lots 9CFR 113.52c,113.53a* 10ml/1g/

6 x 1 ml aliquots 28 days

Mycoplasma Detection with Inhibition-Indicator cell culture method

EPUSP-MY-IN-IND Serum, powder, cell lines/stocks, virus banks/lots EP 2.6.7, USP<63> 10ml/1g/

10 x 1 ml aliquots 28 days

Mycoplasma Detection with Inhibition-Direct Culture EPUSP-MY-IN-DIR Serum, powder, cell lines/stocks, virus banks/lots EP 2.6.7, USP<63> 75ml/5g/

75 x 1 ml aliquots 28 days

Mycoplasma Detection without Inhibition-Indicator cell culture method

EPUSP-MY-IND Serum, powder, cell lines/stocks, virus banks/lots EP 2.6.7, USP<63> 5ml/1g/

5 x 1 ml aliquots 28 days

Mycoplasma Detection without Inhibition-Direct Culture EPUSP-MY-DIR Serum, powder, cell lines/stocks, virus banks/lots EP 2.6.7, USP<63> 35ml/5g/

35 x 1ml aliquots 28 days

Large Volume Mycoplasma Detection –Direct Culture (Barile’s method) LVB-MY-DIR Bovine serum n/a 100ml 28 days

Large Volume Mycoplasma Detection–Indirect cell culture method LVB-MY-IND Bovine serum n/a 50ml 9-11 days

*Inhibition assay is not required by 9CFR

Products:

Ask us about our antibody test kits and immunofluoroscence reagents. With 14 USDA licensed antibody test kits, VMRD is a reliable partner in the veterinary diagnostics industry.

VMRD’s immunofluorescence reagents are set apart by quality, consistency, standardization and support.

Not finding what you need? We offer a wide range of custom testing to satisfy your testing requirements. For more information

Tests:

SenecavirusA, BVDV3 (Hobi virus),Custom Assays

Ask us about assays we are developing to address pending regulatory requirements.

• SenecavirusA (SVA) testing

• BVDV3 (Hobi virus) testing

• Equine parvovirus-hepatitis (EqPV-H) testing

• Equine hepacivirus testing

• Avian testing

New

Enjoy online access with our Client Portal.

VMRD’s Client Portal acts as a bridge between you and our Laboratory Information Management System (LIMS). This portal lets you schedule sample submissions, request testing, and have secure 24-hour access to up-to-date testing information such as test status. In addition, final reports are available immediately after QA approval, which provides you with faster access to results. Take advantage of this new tool for a personalized testing experience.

Learn more about our Client Portal or to sign up, please contact one of our Customer Experience Representatives by email.

Access

vmrd@vmrd.com

vmrd@vmrd.com Phone: 509-334-5815 Fax: 509-332-5356 Toll Free: 800-222-8673 VMRD, Inc., P.O.Box 502, Pullman, WA 99163