Regenerative Medicine Production Manufacturing Insurance (UK): A Practical Guide for GMP Facilities

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Regenerative Medicine Production Manufacturing Insurance (UK): A Practical Guide for GMP Facilities

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Regenerative medicine is moving from research into real-world manufacturing at pace. Whether you’re producing cell therapies, gene therapies, tissue-engineered products, or advanced therapy medicinal products (ATMPs) for clinical trials and commercial supply, the operational and regulatory demands are intense. You’re managing sterile environments, complex supply chains, temperature-sensitive materials, specialist equipment, and strict quality systems — all while working under UK regulatory oversight.
That combination creates a risk profile that standard “manufacturer’s insurance” often doesn’t fit. Regenerative medicine production needs insurance that understands Good Manufacturing Practice (GMP), cleanrooms, cold chain, clinical trial supply, high-value batches, and the reality that one incident can destroy months of work and trigger contractual, regulatory, and reputational fallout.
This guide explains the key risks in regenerative medicine production and the types of insurance UK manufacturers typically need — in plain English — so you can build a programme that protects your facility, your people, your batches, and your balance sheet.
What counts as regenerative medicine production manufacturing?
Regenerative medicine manufacturing covers a range of activities, including:
  • Cell therapy manufacturing (autologous and allogeneic)
  • Gene therapy manufacturing (including viral vector production)
  • Tissue engineering and scaffold-based products
  • ATMP manufacturing for clinical trials and commercial supply
  • Ancillary materials (critical inputs used in therapy manufacture)
  • Fill/finish, packaging, labelling, and Qualified Person (QP) release activities
  • Storage and distribution of temperature-sensitive therapies (including cryogenic storage)
Some businesses operate as CDMOs/CMOs, some are vertically integrated (R&D through to supply), and others manufacture under contract for universities, hospitals, or biotech sponsors. Insurance needs vary depending on where you sit in the chain — but the core exposures are similar.
Why regenerative medicine manufacturing risk is different
Traditional manufacturing risks still apply — fire, flood, theft, machinery breakdown, employee injury — but regenerative medicine adds layers that can multiply the impact of an incident:
  • Batch value can be extreme (and not always obvious in standard stock declarations)
  • Time sensitivity (especially autologous therapies with patient-specific timelines)
  • Strict environmental controls (cleanroom classification, pressure differentials, HVAC dependence)
  • Cold chain and cryogenic reliance (LN2 systems, freezers, alarms, monitoring, backup power)
  • Regulatory consequences (MHRA inspections, deviation investigations, potential recalls)
  • Contractual penalties (service-level agreements, trial timelines, sponsor obligations)
  • Data and system dependency (MES, LIMS, QMS, electronic batch records, validated systems)
In practice, a “minor” incident like a short power interruption, a freezer alarm failure, or a cleanroom HVAC fault can cause a total batch loss, trigger an investigation, and delay supply — which then becomes a business interruption and liability problem, not just a property claim.
Core insurance covers for regenerative medicine manufacturers
Most UK regenerative medicine production sites build their insurance around a commercial combined policy, then add specialist covers. Here are the main components to consider.
  1. Property insurance (buildings, contents, and stock)
Property insurance covers physical loss or damage at your premises — for example from fire, flood, escape of water, storm, theft, or accidental damage (depending on policy terms).
For regenerative medicine, the key is ensuring the policy correctly reflects:
  • Cleanroom build costs (far higher than standard fit-out)
  • Specialist plant (HVAC, HEPA filtration, environmental monitoring systems)
  • High-value equipment (bioreactors, isolators, incubators, centrifuges, freezers)
  • Stock and materials including WIP (work in progress), reagents, consumables, finished therapies
  • Stock at temperature (frozen/cryogenic) and how it’s defined and valued
Common gap: stock limits that are too low, or stock definitions that don’t clearly include WIP, patient-specific materials, or goods held in trust for clients.
  1. Business interruption (BI)
Business interruption insurance covers loss of gross profit (or revenue) and increased costs of working after an insured event causes disruption. For regenerative medicine, BI is often as important as property cover because downtime can be catastrophic.
Key BI considerations include:
  • Indemnity period (how long the policy will pay for). Cleanroom rebuilds, revalidation, and regulatory sign-off can take months.
  • Increased cost of working (outsourcing production, expedited logistics, temporary facilities)
  • Dependency on utilities (power, water, gas) and whether utility failure is covered
  • Supplier/customer extensions (if a critical supplier or contract manufacturer goes down)
Common gap: indemnity periods set for “normal” factories (12 months) when a GMP facility may need 18–24 months depending on complexity and validation requirements.
  1. Equipment breakdown / machinery breakdown
Equipment breakdown (sometimes called engineering insurance) covers sudden and unforeseen mechanical or electrical breakdown of insured equipment. It can also include associated BI.
This is particularly relevant for:
  • Ultra-low temperature freezers and cryogenic systems
  • HVAC and environmental control systems
  • Autoclaves, sterilisation equipment, washers
  • Bioreactors, filling lines, isolators, robotics
  • Compressed air and critical utilities
Common gap: policies that cover the repair of the machine but not the consequential loss of product/batches, or not enough cover for spoilage/temperature deviation.
  1. Deterioration of stock / temperature deviation / spoilage
If you store temperature-sensitive materials, you’ll want cover that responds when stock is spoiled due to temperature change, refrigeration failure, freezer breakdown, or alarm/monitoring failure (subject to terms).
Regenerative medicine manufacturing often involves:
  • -80°C storage
  • Liquid nitrogen (LN2) storage
  • Validated cold rooms
  • Temperature-mapped storage areas
  • Transport packaging and shipper systems
What to check: whether cover applies to stock in freezers, in cold rooms, in cryogenic vessels, and during internal movements; whether “stock” includes client-owned materials; and whether there are requirements for dual alarms, call-out procedures, maintenance logs, or backup power.
  1. Product liability and public liability
Product liability covers claims arising from products you manufacture/supply that cause injury or property damage. Public liability covers injury or damage arising from your premises/operations (e.g., a visitor injury).
In regenerative medicine, product liability can be complex because:
  • Products may be used in clinical trials
  • There may be multiple parties (sponsor, manufacturer, logistics provider, hospital)
  • Allegations may include contamination, mislabelling, deviation, or failure to meet specification
Important: you should disclose the nature of the products, territories, clinical trial involvement, and whether you manufacture under contract. Some policies have exclusions or special conditions around pharmaceuticals, clinical trials, or human-derived materials.
  1. Product recall / contamination / rectification costs
Even with strong quality systems, recalls can happen — and the costs aren’t just about collecting product. There are investigation costs, notification costs, disposal, replacement, and sometimes crisis management.
Depending on your operations, you may need cover for:
  • Recall expenses (communication, retrieval, logistics)
  • Contamination events (including suspected contamination)
  • Product rectification (repair/rework where possible)
  • Third-party recall costs if you’re contract manufacturing
Common gap: assuming product liability automatically covers recall costs. Often it doesn’t unless specifically added.
  1. Professional indemnity (PI) / errors & omissions
Many regenerative medicine manufacturers provide services as well as products: process development, tech transfer, QA/QP services, validation support, stability programmes, documentation, and release activities. If a client alleges your advice, documentation, or professional services caused them financial loss, PI is the cover that typically responds.
PI can be relevant for:
  • CDMOs/CMOs manufacturing under contract
  • Consultancy and validation services
  • QP release services (where applicable)
  • Design and specification work
Common gap: relying on product liability alone when the claim is actually for financial loss due to an error in service, documentation, or process control.
  1. Employers’ liability (EL)
Employers’ liability is legally required in the UK for most employers. It covers claims from employees who suffer injury or illness due to their work.
Regenerative medicine manufacturing may involve:
  • Exposure to biological agents (depending on materials handled)
  • Chemicals and solvents used in cleaning and processing
  • Manual handling and repetitive tasks
  • Sharps, glassware, pressurised systems
  • Shift work and fatigue risks
Insurers will often look for strong health & safety management, training records, COSHH assessments, and incident reporting.
  1. Cyber insurance
Manufacturing is increasingly digital. If your production depends on validated systems, electronic batch records, LIMS, QMS, or networked monitoring, cyber events can stop production and compromise data integrity.
Cyber insurance can help with:
  • Business interruption from cyber incidents
  • Ransomware response and recovery
  • Data breach response (including regulatory notifications)
  • Digital forensics and system restoration
Why it matters in GMP: beyond downtime, you may face questions about data integrity, audit trails, and whether batches can be released if systems were compromised.
  1. Directors’ & officers’ (D&O) liability
If you’re a growing biotech manufacturer or a funded business, D&O can be important. It covers directors and officers against claims alleging wrongful acts in management — for example from investors, regulators, competitors, or other stakeholders.
This is especially relevant where you have external investment, rapid growth, or complex regulatory obligations.
  1. Cargo / goods in transit (including cold chain)
If you ship temperature-sensitive materials, you’ll want to consider goods in transit cover that matches your logistics reality. This can include:
  • Courier and specialist medical logistics
  • Dry ice shipments
  • Cryogenic shippers
  • International movements (where applicable)
  • Client-owned goods in your custody
Common gap: assuming the courier’s liability is sufficient. Standard carrier liability is often limited and may not reflect the true value of therapies or materials.
Key risk areas insurers will focus on (and how to prepare)
When underwriting regenerative medicine production, insurers typically want confidence that you can prevent incidents and limit losses. Expect questions around:
Cleanroom and contamination control
  • Cleanroom classifications and monitoring
  • Gowning procedures and training
  • Environmental monitoring and trending
  • Cleaning validation and change control
  • Deviation management and CAPA
HVAC resilience and critical utilities
  • Preventative maintenance schedules
  • Redundancy (N+1 where feasible)
  • Alarm systems and call-out procedures
  • Backup power arrangements and testing
Cold chain and cryogenic storage
  • Temperature monitoring, alarms, and escalation
  • Backup storage capacity
  • Maintenance and calibration records
  • LN2 supply arrangements and contingency plans
Quality systems and regulatory readiness
  • GMP compliance approach
  • Document control and training records
  • Supplier qualification
  • Batch release and traceability
Contractual risk
  • Clear allocation of liability in manufacturing agreements
  • Limitations of liability and indemnities
  • Insurance requirements in contracts (limits, named insureds, waivers)
Getting your insurance right isn’t just about buying a policy — it’s about aligning your risk controls, documentation, and contracts so the cover responds as intended.
Common insurance mistakes in regenerative medicine manufacturing
A few pitfalls we see when advanced manufacturing businesses buy “standard” cover:
  • Underinsuring cleanrooms and specialist fit-out (leading to reduced claim payments under average clauses)
  • Not declaring true stock/WIP values or failing to include client-owned goods
  • Missing temperature deviation cover or having restrictive conditions around alarms/maintenance
  • BI indemnity periods too short for rebuild + revalidation + regulatory sign-off
  • Relying on product liability for recall costs when recall isn’t included
  • Not matching PI to services provided (especially for CDMOs and technical services)
  • Overlooking cyber-driven downtime and data integrity implications
How to choose the right insurance approach
A good insurance programme for regenerative medicine production usually starts with a structured conversation around:
  • What you manufacture (cell/gene/tissue, clinical vs commercial, batch sizes, values)
  • Your facility (cleanrooms, HVAC, utilities, security, flood exposure)
  • Storage and logistics (freezers, LN2, monitoring, transport responsibilities)
  • Your contracts (liability clauses, required limits, indemnities)
  • Your compliance framework (GMP, MHRA interactions, QMS maturity)
  • Your growth plans (new products, new sites, international distribution)
From there, you can build a programme that’s realistic, insurable, and aligned to your biggest exposures — rather than paying for generic cover that leaves critical gaps.
Regenerative medicine manufacturing insurance: quick checklist
  • Property sums insured reflect cleanroom rebuild and specialist plant
  • Stock/WIP values are accurate and definitions include what you actually hold
  • Equipment breakdown includes critical utilities and consequential loss where needed
  • Temperature deviation/spoilage cover matches your cold chain reality
  • BI indemnity period is long enough for rebuild + revalidation
  • Liability cover reflects clinical trial involvement and territories
  • Recall/contamination cover is included if exposure exists
  • PI is in place for service-based exposures (CDMO, QP, validation, documentation)
  • Cyber cover reflects operational dependency and downtime risk
Speak to a specialist broker who understands advanced manufacturing
Regenerative medicine production is one of the most operationally sensitive areas in UK life sciences. The right insurance programme should protect your facility and balance sheet without slowing you down with unnecessary complexity.
If you manufacture regenerative medicine products in the UK and want to sanity-check your current cover or build a new insurance programme, speak to Insure24 for a review and a tailored quote.

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