Objectives

The primary objective of this tender is to engage a suitably accredited service provider to authenticate baby hamster kidney (BHK-21) cell lines and conduct testing for extraneous agents. The testing aims to ensure the cell lines' authenticity and safety in compliance with international regulatory standards, supporting vaccine production and quality control processes.

Scope

The scope includes:

• Authentication of two BHK-21 cell line clones (13 and 38) via species identification using STR profiling.
• Testing for a specified panel of extraneous agents, including BTV, BAdV, BRSV, Reovirus, Rabies virus, BVDV, BCV, BPiV3, BHV, and HAP tests.
• Conducting tests under GMP compliance, adhering to US FDA, EMA, and MHRA standards.
• Testing of stored master cell stock stored in ampules with specified concentration and viability.
• Provision of detailed methodology, compliance certifications, and testing locations.
• Delivery of results within a maximum turnaround time of 12 months from receipt of the test material.

Technical Requirements

The technical requirements specify that:

• The service provider must conduct species identification (STR profiling) of the cell lines.
• Testing for the listed extraneous agents must be performed according to GMP standards and regulatory guidelines (FDA, EMA, MHRA).
• The provider must have the capacity to perform the tests either locally or through international collaboration with accredited laboratories.
• Testing methodology must be clearly documented and compliant with relevant quality standards.
• The provider must have previous experience in cell authentication services.
• All testing must be performed under a Material Transfer Agreement (MTA) with ARC prior to material release.

Skills Requirements

The skills and qualifications required from the service provider include:

• Proven experience in cell line authentication and extraneous agents testing.
• Accreditation to perform GMP-compliant testing according to US FDA, EMA, and MHRA standards.
• Capability to conduct species identification using STR profiling techniques.
• Ability to handle proprietary biological material securely and in compliance with legal agreements.
• Demonstrated capacity to deliver accurate, reliable, and timely results within the specified 12-month period.
• Experience in international collaboration with accredited laboratories, if applicable.
• Knowledge of regulatory and quality standards relevant to vaccine production and cell line testing.