Lot Release Testing Services

Roswell Park Comprehensive Cancer Center is soliciting proposals from qualified companies and institutions to provide lot release testing services through a competitive Request for Proposal (RFP #25-516) issued on June 11, 2024. This ongoing procurement seeks to establish a 3 to 5-year contractual relationship for comprehensive lot release testing of various biological materials, including master cell banks (such as 293T and Wild Type PG13 cells), gamma-retrovirus from producer cell lines, producer cell line testing, and lentivirus or retrovirus generated by transient transfection. The scope includes assays such as sterility, endotoxin, mycoplasma, residual human DNA, vector insert stability, viral contaminants, and sequencing of genes of interest, all conducted in accordance with Good Laboratory Practices and applicable federal, state, and local regulations. Vendors must maintain relevant certifications, including GMP, ISO, and possess valid Drug Master Files when applicable. The contract emphasizes compliance with FDA regulations (21 CFR), United States and European Pharmacopeia standards, and Roswell Park’s specifications, and it mandates detailed documentation such as a Certificate of Testing for each lot. Contract award will be based on a best-value evaluation with factors weighted heavily towards financial considerations (40%), responsiveness to Roswell Park’s needs (30%), and vendor qualifications and references (22%). The procurement encourages continuous submissions with no fixed deadline, promoting vendor flexibility. Respondents must submit a comprehensive proposal package including business information, experience, certifications, EEO policies and staffing plans, confidentiality and non-collusion affidavits, and pricing details. The contract incorporates stringent equal employment opportunity and affirmative action requirements aligned with New York State laws, ensuring nondiscrimination and workforce diversity. The master Lot Release Testing Agreement, supported by detailed Statements of Work, governs service execution, deliverables, subcontractor use, compensation, invoicing, and termination provisions. Deliverables are to be inspected at the vendor site and accepted at Roswell Park in Buffalo, NY, with results and certifying documentation transferred as works made for hire. Prior contracts for similar services have been awarded to entities like Eurofins, Indiana University, and Wuxi, illustrating the caliber of vendor Roswell Park seeks. Contact for this procurement is Rob Henschel, Strategic Sourcing Manager, reachable via email or phone for proposal submissions and inquiries.