Human Biospecimens for Research

Quality & Compliance

At BioHippo, we are committed to delivering high-quality biospecimens through strict adherence to regulatory standards and ethical guidelines. In collaboration with our trusted supplier, Capital Biosciences (CBI), we ensure that all biospecimens are collected, processed, and delivered with the utmost precision, safeguarding the integrity of your research.

Quality Assurance

Our robust quality system ensures that every step of the biospecimen procurement and handling process follows stringent protocols:

Consistent and Uniform Collection Protocols: We follow standard operating procedures (SOPs) for specimen collection, ensuring consistency across every sample.
Chain of Custody: All biospecimens are tracked through a comprehensive chain of custody, from collection to delivery, guaranteeing specimen authenticity and integrity.
Dual Control and Verification: Two lines of control and verification are implemented to validate every process, ensuring reliability and accuracy.
Independent Morphology Verification: All tissue samples undergo independent verification by a U.S. pathologist to ensure specimen quality and appropriateness for research.
Cell Viability and Quantity Control: For viably frozen tissues and cells, we monitor cell viability and quantity, including DNA integrity via chip electrophoresis.

Ethical Considerations

BioHippo upholds the highest ethical standards in all biospecimen sourcing activities. Our practices comply with U.S. and international regulations, ensuring that patient rights and privacy are fully respected:

Full Consent and IEC/IRB Approvals: All biospecimens are collected with the informed consent of donors, with approvals from Institutional Review Boards (IRB) or Independent Ethics Committees (IEC).
Compliance with GCP and HIPAA: We adhere to Good Clinical Practice (GCP) guidelines and ensure full compliance with the Health Insurance Portability and Accountability Act (HIPAA) to protect patient information and privacy.
Specimen De-Identification and Honest Broker Mechanism: All biospecimens are fully de-identified before use, protecting patient privacy while ensuring access to necessary clinical data. Our Honest Broker mechanism facilitates the secure transfer of de-identified data.
No Patient Compensation: In line with ethical regulations, no compensation or retribution is provided to patients for the donation of biospecimens.

Regulatory Compliance

We ensure that all biospecimens meet national and international regulatory requirements:

Adherence to U.S. and International Laws: All specimen procurement and handling processes comply with relevant laws and regulations, both in the U.S. and globally.
Compliance with Biospecimen Procurement Regulations: Our practices ensure that all biospecimen collections, logistics, and distribution are carried out ethically and legally.

Commitment to Excellence

With over 10 years of experience in biospecimen procurement through CBI, BioHippo maintains high standards for biospecimen quality, ethical sourcing, and regulatory compliance. Our commitment to excellence is reflected in our dedication to supporting research while ensuring ethical and regulatory integrity at every step.

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