The build vs buy decision

The factors that influence the decision to build or buy a screening solution will vary from one organization to the next. However, every organization should consider these key factors in their decision:

1. Time to Compliance

• Developing a minimum viable product for an in-house screening system can take 6 to 12 months
• Commercial solutions can be implemented in weeks
• Regulatory deadlines influence the most feasible approach

2. Resource Investment

• In-house development demands significant engineering and scientific expertise
• Commercial solutions involve licensing or subscription costs
• In-house solutions carry hidden ongoing costs including maintenance, updates, and compliance monitoring

3. Compliance Risk

• Commercial solutions are typically validated against industry standards
• In-house systems must be updated regularly to match evolving regulations
• Customer screening and documentation requirements add complexity

Understanding these factors can frame the build versus buy decision based on your organization's specific circumstances in addition to the benefits of control or customization over an in-house system.

The changing regulatory environment for DNA and RNA screening spans multiple frameworks and jurisdictions, with frequent updates impacting compliance requirements:

1. Diverse compliance regimes

• Domestic biosecurity regulations like FSAP in the U.S. and the U.K.’s Schedule 5
• Domestic biosafety regulations like USDA APHIS permits and UK Control of Substances Hazardous to Health
• Export control regulations like the U.S. Commerce Control List (CCL) and the E.U.’s Dual-Use Export Control List
• Federal funding requirements like the U.S. Office of Science and Technology Policy (OSTP) Framework for Nucleic Acid Synthesis and Screening
• Industry guidance like U.S. Department of Health and Human Services Screening Framework
• Additional policy and guidance like U.S. DURC and UK Screening Guidance

2. Accelerating regulatory evolution

• U.S. Commerce issues rules to reflect export control coordination with allies and partners and facilitate secure trade (December 2023)
• Changes to Select Agent and Toxin List – Publication of HHS and USDA Final Rules (December 2024)
• The U.S. OSTP Screening Framework adds federal funding mandates (April 2024)
• Scheduled reviews and updates to the U.S. OSTP Screening Framework every two years starting in 2026

This dynamic landscape creates ongoing challenges for screening systems to regularly update and maintain compliance. Teams that choose to build in-house systems must dedicate resources to tracking and implementing new changes, while commercial solutions often offer up-to-date screening through contractual obligations or warranties.

Building an in-house customer and sequence screening system demands significant attention from leadership, R&D, product, and customer support teams, which can distract from revenue-generating activities.

Customer screening system
While there are many commercially available options for sanctions and watchlist screening, it’s important to consider the time to integrate the software with an in-house biosecurity system and process. This often takes weeks to get right.

Sequence screening system
Developing a minimally viable sequence screening system can take 6 to 12 months. A fully automated approach can take even longer to set up. Without automation, R&D and customer support teams must spend more time fulfilling each order, introducing a cost of its own that needs to be considered when building in-house.

Maintaining a compliance database
As regulations evolve (e.g., biennial reviews of the 2024 White House Screening Framework starting in 2026), systems need regular updates. Challenges include identifying sequences of concern from regulatory documents and refining whitelists to minimize false positives from common genetic engineering tools like TALENs (virulence-associated proteins from controlled plant pathogens) and 2A peptides (proteins from controlled animal viruses like Porcine Teschovirus). Addressing these challenges often requires extensive legal and scientific expertise.

Order and compliance management system
Screening systems must track flagged orders that require action (e.g., filing a license, verifying customer credentials and biosafety, or reporting suspicious activity). With multiple team members responsible for parts of the biosecurity process, it’s especially important to build a system that can reconcile the various compliance states.

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Your decision should align with your organization's specific circumstances. Commercial solutions typically offer faster compliance, predictable costs, and lower risk. If your team has existing biosecurity infrastructure or expertise and unique screening needs, building in-house might make sense. Starting with a commercial solution can ensure immediate compliance and give your organization flexibility to assess long-term needs as you grow.

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We’re here to help. Our team can assist you in evaluating your options and finding the best solution for your needs.

Learn how you can reduce your compliance risk and meet federal funding requirements faster by requesting a demo.

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