What cybersecurity does a biotech company need?
A biotech company needs cybersecurity that protects three things: research IP, regulated data whose integrity FDA relies on, and the lab and manufacturing operations that depend on IT. Build it on a recognized framework such as NIST CSF 2.0, starting with company-managed identity and MFA, managed devices, segmented instrument networks, tested backups and logging. Add NIST SP 800-171 if you analyze NIH controlled-access genomic data.
Why biotech is different
Your most valuable asset is usually unpublished data: sequences, assay results, process know-how and patent drafts. A breach can destroy patentability or a partnering position, not just cause downtime.
Regulated work adds integrity requirements. FDA expects data to be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), so tampering or loss can become a compliance finding. And lab instruments often run vendor-controlled software that you cannot patch on your own schedule.
Start from a framework
NIST released Cybersecurity Framework 2.0 on February 26, 2024, for organizations of any size, sector or maturity. Its six functions, Govern, Identify, Protect, Detect, Respond and Recover, give leadership a common language for setting priorities and reporting progress to a board or investors. CSF describes outcomes, not specific products, so you decide how to achieve them.
Controls that matter most
- Company-owned identity with multifactor authentication and unique accounts; no shared logins on regulated systems.
- Managed, encrypted laptops and prompt removal of access when people leave.
- Lab and instrument networks separated from office systems, with restricted remote access for vendors.
- Backups of research and regulated data that are isolated from production and restore-tested.
- Central logging and alerting for identity, email and file access.
- Governed file sharing with CROs, CDMOs and academic collaborators, and a governed AI tool.
Obligations you may already have
FDA's 2018 data integrity guidance states that shared login accounts do not meet drug CGMP requirements for actions that must be attributable, and expects audit trails to be reviewed with the records they support.
If your scientists use NIH controlled-access data under the Genomic Data Sharing Policy, NIH has expected since January 25, 2025 that approved users attest their institution, and any third-party or cloud system they use, complies with NIST SP 800-171.
Where to begin
Name an executive owner, write down what data you hold and where, score yourself against CSF 2.0, and fix identity, backup and device management first. Then write an incident response plan that names your legal counsel and insurer, and test it once with leadership.
Revisit the CSF self-assessment at least once a year, and again whenever you start regulated work, add a manufacturing partner or take on controlled-access data.
Common follow-up questions
Does a biotech need SOC 2 or ISO 27001?
No regulation requires either for a typical biotech. Partners, pharma licensees or customers may ask for one in diligence or contracts. A program built on NIST CSF 2.0 creates most of the evidence either attestation would need later.
Do we need NIST SP 800-171 for dbGaP or other NIH genomic data?
If you are an approved user of NIH controlled-access data under the Genomic Data Sharing Policy, yes. Since January 25, 2025 NIH expects an attestation that your institution and any third-party or cloud system used comply with NIST SP 800-171.
How do we secure lab instruments we cannot patch?
Isolate them on a separate network segment, limit who can log in, block internet access they do not need, control USB use, and route vendor remote support through a monitored, approved path. Document the risk and the compensating controls.
LAN Service Group provides managed IT, cybersecurity and GxP-regulated IT for life-science and biotech companies, including identity, device management, network segmentation and backup for research and regulated data.
Talk to LAN Service Group (888) 281-7243