Cell Analysis and Reagents

CTT offers several versatile manufacturing and packaging solutions for custom products to meet specific research needs. If required, custom products can be manufactured in a BD cGMP facility.

Clients can define packaging and labeling of custom products for easy handling and tracking of reagents in the lab. CTT offers unique packaging options such as lyophilization of antibodies, antibody cocktails, immunological proteins, and cells to improve standardization and reduce hands-on time.

CTT provides central order tracking with transparent due dates and tight estimates for delivery to help maximize lab productivity. Standing orders and batch delivery can be set up for high-volume orders to allow clients to effectively manage inventory to reduce costs.

CTT has conducted cell and protein analysis studies for many major biotechnology and pharmaceutical companies. Thousands of samples have been processed in various studies for cancer, autoimmunity, infectious disease, and HIV therapeutics and vaccines. Expertise in the typical study processes, combined with expertise in cell and protein analysis, can translate into efficient study completion for clients.

CTT can:

• Develop a proposal that outlines the assays to be used
• Develop study protocols and SOPs that optimize collection and transport conditions in coordination with research and logistical teams
• Conduct feasibility studies using known positive and negative controls
• Conduct qualification studies to assess sample-to-sample variation, transport stability, intra-assay variability, inter-technician variability, and normal range expectations
• Receive, accession, and track study samples using established SOPs
• Process and analyze study samples following assay protocols
• Submit a cumulative data file and comprehensive bioanalytical study report providing all information necessary to properly interpret study results

The CTT ensures that industry best practices for quality are followed by instituting comprehensive quality control systems. The team also participates in the CAP (College of American Pathologists) Proficiency Survey for Flow Cytometry and Hematology.

• All custom products are tested to lot-to-lot specifications to reduce batch variation. Pre- and post-bottle quality testing is employed. The BD Biosciences facility for custom product creation is ISO 9001:2000 certified.
• Unique protocols for each individual study are tracked, ensuring that every sample is handled consistently and reliably. CTT personnel are trained to handle biohazards, and BD Biosciences maintains personnel training records.
• Instruments are validated for use in human studies and equipment is maintained on a regular maintenance and calibration schedule. Storage devices are monitored daily to ensure proper sample storage conditions and maintain sample integrity.
• Data is stored on a secure server and is password protected, and redundant copies of data are archived.