CAPABILITIES

BIOSPEC INCORPORATED HAS SOLUTIONS FOR BIOBANKING, BIOREPOSITORIES, AND BIOMARKER ASSAY CONSULTING.

BIOMARKER & ASSAY CONSULTING

BIOBANKING

OVERSIGHT

BIOREPOSITORY CONTROL

During an initial consultation with the Principal Investigator of a department or a specific protocol, BIOSPEC will discover the type, volume, and frequency of the human biospecimens to be collected as part of the established requirements for the study. The PI will provide a copy of the Protocol, a Consent Form, a Study Flowsheet, and a Timepoint-Oriented Blood Draw Volume Sheet.

Based on the information provided in the above listed documents, BIOSPEC will develop an Organizational Sequencing Plan, which will utilize various elements and methods of Bioprocessing Technology to facilitate in the collection, e-tracking, and repository storage of the biospecimens for each protocol. All collection methods and materials will be specified in the BIOSPEC Practitioner Flowchart (provided prior to the clinical study). For Peripheral Blood Mononuclear Cell Separation (PBMC) specific arrangements and planning must be done to insure the success of the procedure and viability of the live cells.

After the completion of a specific protocol’s day, all the BioTechnician’s Lab Flowchart notes for that protocol are merged into the BIOSPEC Biospecimen Inventory and Tracking System (BITS) for that protocol. This inventory system captures the disposition and history of every biospecimen in the BioRepository. Each biospecimen which has been stored, starting with the beginning and continuing throughout the end of the study is cryo-vial barcode-labeled and uniquely numbered for each protocol. Information is entered for each human biospecimen collected and is identified by a unique identifier, that includes but is not limited to custodianship, current location, aliquot tracking, significant event tracking (e.g. thaws, processing, exhaustion, and destruction), and transfers into and out of the repository The BIOSPEC BIT Systems meets federal requirements related to data privacy and security, as cited and referenced in the Privacy Act of 1974, 5 U.S.C. § 552a (a)(8)(B)(i).

After an accumulation period, biospecimens to be stored long-term are inventoried and then rotated into a long-term storage facility. BIOSPEC will manage a centralized freezer community (Freezer Farm), which has the capacity for hundreds of thousands of samples and can safely store these human biospecimens for long-term at -86°C or colder, until they are requested for analysis at the end of a protocol. As with all freezers repositories, our main emphasis is on a high degree of temperature integrity as well as sample security.

Utilizing web-based monitoring and alarm notification equipment, BIOSPEC seeks to maintain the optimal life of mechanical refrigeration equipment, the repository and lab ambient temperatures are monitored and not allowed to exceed +22°C. This is particularly critical for Freezer Farms and Labs, as these rooms contain multiple mechanical units. In addition, BIOSPEC will enable monitoring of Oxygen and CO2 levels via sensors.