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CELL BANK & SPECIALIZED MEDICAL & SCIENTIFIC LABORATORY TESTING SERVICES |
| (contract last updated 07/19/2013) |
| SCOPE: Contract for the Waisman Clinical Biomanufacturing Facility (WCBF) for specialized medical and scientific laboratory testing services. Primarily, but not exclusively, these are Cell Bank Testing Services. |
|
| CONTRACT # |
DESCRIPTION |
|
11-5035 |
CELL BANK & SPECIALIZED MEDICAL & SCIENTIFIC LABORATORY TESTING SERVICES |
| CONTRACT ORIGIN: |
ADDITIONAL INFORMATION: |
UW-Madison
Purchasing Services
21 N Park St, Ste 6101
Madison, WI 53715-1218 |
UW-Madison users contact:
Janet Bresnahan
(608) 262-6335 FAX (608) 262-4467
jbresnahan@bussvc.wisc.edu |
| |
Non-UW-Madison users contact: Vendor Representative |
| RESTRICTED: |
Restricted to: Waisman Clinical Biomanufacturing Facility (WCBF) |
| COOPERATIVE PURCHASING: |
NO |
| CONTRACT TERM: |
August 1, 2010 through September 30, 2013, unless amended, cancelled or
rebid. |
|
| Vendor(s) |
| 108693 |
| Bioreliance Corporation |
| 14920 Broschart Rd |
| Rockville MD 20850 3349 |
| |
|
|
| Sales Representative: |
PHONE # |
FAX # |
| Mary Jane Padalino |
734-645-4923 |
815-895-9413 |
| E-mail:maryjane.padalino@bioreliance.com |
| |
PHONE # |
FAX # |
| Ordering/Expediting: |
800-756-5658 |
310-738-1605 |
| Invoice Information: |
800-756-5658 |
310-738-1605 |
| Returns: |
800-756-5658 |
310-738-1605 |
| Supplier Diversity Reporting: |
301-610-2652 |
|
| Website: www.bioreliance.com |
|
| Commodity Code |
961-48 |
| Federal Employee ID # (FEIN) |
54-1831899 |
| F.O.B. |
“D” F.O.B. DESTINATION, FREIGHT PREPAID AND ALLOWED |
| Terms: |
N/30 |
| Invoicing: |
Invoices shall reflect contract pricing |
| Orders: |
E-mail, Fax, Internet, Mail |
| Other: |
Pricing not available to: University of Wisconsin System campuses, State of Wisconsin Agencies or Wisconsin Municipalities |
| Pricing Information: |
Contact purchasing agent at (608) 262-6335 or jbresnahan@bussvc.wisc.edu for pricing. |
Rush job scenario 2 – Turnaround Time in Days: assay dependent
Mark Up Rate or Fee 20% of assay pricing
DNA Sequencing Cost per Base Pair $ inquire
DNA Extraction Cost per each $$ inquire
All non-listed, related items from contractor’s price list are available at 0% discount. |
|
| Vendor(s) |
| 118309 |
| Wuxi Apptec Inc |
| 2540 Exectutive Dr |
| Saint Paul MN 55120 |
| |
|
|
| Sales Representative: |
PHONE # |
FAX # |
| Tracey Partington |
603-880-8750 |
814-284-8750 |
| E-mail:tracey.partington@wuxiapptec.com |
| |
PHONE # |
FAX # |
| Ordering/Expediting: |
215-218-5500 X5537 |
215-218-5995 |
| Invoice Information: |
651-675-2000 X2288 |
651-675-2005 |
| Returns: |
215-218-5500 X5537 |
215-218-5995 |
| Supplier Diversity Reporting: |
651-675-2000 |
651-675-2005 |
| Website: www.wuxiapptec.com |
|
| Commodity Code |
961-48 |
| Federal Employee ID # (FEIN) |
41-2006925 |
| F.O.B. |
“D” F.O.B. DESTINATION, FREIGHT PREPAID AND ALLOWED
WuXi AppTec reserves the right to change pricing based on the scope of work and specific project details. |
| Delivery: |
Standard Turnaround Time: 14-18 weeks
Rush Turnaround Time: 11-15 weeks |
| Terms: |
N/30 |
| Invoicing: |
All testing is invoiced at 100% upon issuance of final report. Invoices are billed and payable in U.S. dollars only. |
| Orders: |
E-mail, Fax, Mail |
| Pricing Information: |
Contact purchasing agent at (608) 262-6335 or jbresnahan@bussvc.wisc.edu for pricing. |
Rush job scenario 1 – Standard Turnaround Time: 14-18 weeks
Rush Turnaround Time: 11-15 weeks
Additional charges may apply, up to 50% of the cost of an assay |
| Test |
Human cell line |
Rodent Cell Line |
Microbial Cell Line |
| Bioburden (bacteria, fungi) |
PTC - 21 CFR 610.12 USP <71> |
PTC - 21 CFR 610.12 USP <71> |
Detect non-host organisms, USP <61> |
| Mycoplasma |
PTC and EU Specifications |
PTC and EU Specifications |
NA |
| Bovine adventitious virus |
Assay in susceptible bovine cell line, 9CFR113 for all RMs |
Assay in susceptible bovine cell line, 9CFR113 for all RMs |
NA |
| Porcine adventitious virus |
Assay in susceptible porcine cell line, 9CFR113 for all RMs |
Assay in susceptible porcine cell line, 9CFR113 for all RMs |
NA |
| Adventitious virus- In vitro assay |
3 cell types, inoculate with lysate - please quote for additional lines in case needed |
3 cell types, inoculate with lysate - please quote for additional lines in case needed |
NA |
| Adventitious virus - In vivo assay |
Suckling/adult mice, guinea pigs, in ovo |
Suckling/adult mice, guinea pigs, in ovo |
NA |
| Cell Line Characterization |
Isoenzyme Analysis
Karyotyping G-band
STR ID Testing
FISH Testing
HLA Testing |
Isoenzyme Analysis
STR ID Testing |
DNA Sequencing, Plasmid Copy Number, Integration/Retention, Restriction Map |
| Retrovirus |
SEM, cell culture amplification with S+L- infectivity assay, PERT - RT |
SEM, cell culture amplification with S+L- infectivity assay, PERT - RT |
NA |
| Retrovirus/Viruses |
Transmission EM |
Transmission EM |
NA |
| Tumorogenicity |
In-Vivo and In-Vitro assays per PTC |
NA for continuous rodent lines |
NA |
| Species-specific virus |
HIV-1/2, HTLV 1/2,HAV, HCV, HBV, CMV, EBV, HHV-6, HHV-7, HHV-8, Human Parvovirus B19, AAV, Human Polyoma Virus BKV & JCV, Enterovirus, VZV, SV40, HSV, Rubella, Coronavirus, Influenza Type C, Measels, Reovirus, Chlamydia, HPIV-1, 2 & 3, Treponema Palladium |
(MAP, RAP, or HAP) XC plaque -ecotropic murine leukemia virus |
Bacteriophage testing |
| Other |
|
|
Presence of Host Cell DNA |
|
SPECIFICATIONS
There are typically 350 vials per lot tested. For our purposes, there is no difference between master and working cell banks. Any rodent testing would be a mouse.
Testing is required at varying intervals during the year. The sizes of the DNA will vary.
Microbial cell bank testing to include copy number determination by Southern Blot or equivalent method.
WCBF Test List
Test |
Human cell line |
Rodent Cell Line |
Microbial Cell Line |
Bioburden
(bacteria, fungi) |
PTC - 21 CFR 610.12
USP <71> |
PTC - 21 CFR 610.12
USP <71> |
Detect non-host organisms, USP <61> |
Mycoplasma |
Quote for PTC and EU Specifications |
Quote for PTC and EU Specifications |
NA |
Bovine adventitious virus |
Assay in susceptible bovine cell line, 9CFR113 for all RMs |
Assay in susceptible bovine cell line, 9CFR113 for all RMs |
NA |
Porcine adventitious virus |
Assay in susceptible porcine cell line,
9CFR113 for all RMs |
Assay in susceptible porcine cell line,
9CFR113 for all RMs |
NA |
Adventitious virus-
In vitro assay |
3 cell types, inoculate with lysate - quote for additional lines in case needed |
3 cell types, inoculate with lysate - quote for additional lines in case needed |
NA |
Adventitious virus -
In vivo assay |
Suckling/adult mice, guinea pigs, in ovo |
Suckling/adult mice, guinea pigs, in ovo |
NA |
Cell Line Characterization |
Isoenzyme Analysis
Karyotyping – G-band
STR ID Testing
FISH Testing
HLA Testing |
Isoenzyme Analysis
STR ID Testing |
DNA Sequencing, Plasmid Copy Number, Integration/ Retention, Restriction Map |
Retrovirus |
SEM, cell culture amplification with S+L- infectivity assay, PERT - RT |
SEM, cell culture amplification with S+L- infectivity assay, PERT - RT |
NA |
Retrovirus/Viruses |
Transmission EM |
Transmission EM |
NA |
Tumorogenicity |
In-Vivo and In-Vitro assays per PTC |
NA for continuous rodent lines |
NA |
Species-specific virus |
HIV-1/2, HTLV 1/2,HAV, HCV, HBV, CMV, EBV, HHV-6, HHV-7, HHV-8, Human Parvovirus B19, AAV, Human Polyoma Virus BKV & JCV, Enterovirus, VZV, SV40, HSV, Rubella, Coronavirus, Influenza Type C, Measels, Reovirus, Chlamydia, HPIV-1, 2 & 3,
Treponema Palladium |
(MAP, RAP, or HAP)
XC plaque -ecotropic murine leukemia virus |
Bacteriophage testing |
Other |
|
|
Presence of Host Cell DNA |
PCR Testing
PCR Testing of Mycoplasma and any multiplex PCR Testing for the Human Species-specific Viruses. All testing should be done under GMP/GLP conditions. Indicate in your bid response whether or not your firm can provide PCR Testing under GMP/GLP conditions.
Other
TOC Testing
Osmolality Testing
Replication Competent Virus Testing (Both Adenovirus and Lentivirus)
USP<788> Particulate Testing
USP <61> Microbial Limits Testing
Pricing for Viral Clearance Studies |
|
|
Revision History |
| (5/22/12): change in sales rep for Beckman Coulter Genomics and Bioreliance Corporation. |
| (7/19/13): change in sales rep for Bioreliance Corporation. |
| AMENDMENT #1 (7/19/13): issued to: (1) show extension in contract period to September 30, 2013 for Bioreliance Corporation and Wuxi Apptec Inc only. Beckman Coulter Genomics and Charles River Malvern will not be renewing and are hereby removed from the contract. |
