~25%
Of therapy cost = logistics alone
Life Sciences · Cell & Gene Therapy
Every lot is unique. Your financial system should be too.
Autologous therapies don't move through a supply chain — they move through a chain of identity. Every patient lot has a cost, a timeline, and a compliance obligation that standard ERP was never designed to track. Archer configures NetSuite to handle the financial and operational complexity that advanced therapies introduce.
$400K+
Avg. CAR-T manufacturing cost per patient
$100K
Supply chain cost per CAR-T treatment
COI/COC
Chain-of-identity compliance required
COGS
#1 priority for commercial viability
Where the complexity compounds
Standard ERP can't absorb autologous manufacturing economics.
When a therapy is manufactured for a single patient, every process step has a patient ID attached to it. Every cost has to be tracked to that lot. And every deviation from the expected chain of identity is a potential regulatory event — not just an operational one. Most ERP systems treat inventory as fungible. Cell and gene therapy never can.
Chain-of-identity tracking at every step
From leukapheresis to infusion, the identity of the starting material must remain intact through manufacturing, QC release, and delivery. Generic lot tracking modules can record the movement but can't enforce COI as a hard control on every transaction.
COI failures are among the most frequent quality objections in CGT regulatory submissions
COGS visibility that justifies the price
When a single batch can cost hundreds of thousands of dollars to manufacture, overhead allocation, yield variance, and WIP accounting must be precise — not estimated. Inaccurate COGS directly affects payer negotiations and commercial sustainability.
Logistics alone account for 20–40% of total CGT therapy cost
Vendor and CDMO controls for specialized inputs
Plasmid, viral vector, and cell substrate procurement requires supplier qualification and PO controls that go well beyond standard AP. A rejected raw material lot doesn't just delay a batch — it delays a patient.
Raw material quality objections drive the majority of CGT regulatory delays
Finance processes that conflict with cGMP operations
When financial systems require workarounds to accommodate manufacturing realities — manual journal entries for batch write-offs, spreadsheet COGS summaries — they create audit exposure and distract operations teams from their actual work.
Digitally mature manufacturers experience significantly fewer documentation-related deviations
Purpose-built for advanced therapy manufacturing
The tools that bring financial precision to patient-specific manufacturing.
Archer's modules address the procurement, documentation, and quality workflow intersections that generic configuration misses — and that cell and gene therapy operations can't afford to get wrong.
Archer Module
eQMS Suite
A complete electronic quality management system embedded inside NetSuite — so quality events, deviations, and batch dispositions are tied directly to the financial records they affect. No separate QMS to reconcile at close.
Archer Module
EBR / DHR
Electronic batch records and device history records maintained within the NetSuite environment — linking manufacturing execution data to financial cost records and enabling lot-level COGS reporting that holds up under regulatory review.
Archer Module
Vendor Portal
Automated vendor setup, supplier qualification workflows, and self-service documentation for CDMO partners, vector manufacturers, and cell substrate suppliers — with PO approval controls that prevent unauthorized procurement.
Archer Module
CAPA / Non-Conformance
Corrective and preventive action tracking integrated with financial records — so batch failures, material deviations, and supplier non-conformances trigger the right financial treatment automatically, not manually.
What becomes possible
Financial clarity that supports commercial viability — and patient safety.
When manufacturing data, quality records, and financial systems share a single source of truth, the entire organization operates with less friction and more confidence.
Lot-level
COGS visibility
Real cost per patient, not an estimate
Batch-level cost accounting with overhead absorption, yield variance, and WIP tracking gives finance and operations a shared, auditable view of what each therapy actually costs to manufacture — critical for payer negotiations and cost-reduction programs.
Zero
Manual reconciliation between QMS and ERP
Quality and finance in one system
When CAPA records, batch dispositions, and financial write-offs live in the same environment, close-cycle reconciliation between QMS and ERP disappears — along with the spreadsheet bridges that were holding them together.
Faster
Regulatory submission readiness
COI documentation ready when regulators ask
Chain-of-identity audit trails built into every transaction mean submission-ready documentation is a report, not a reconstruction project — reducing the time and cost of responding to regulatory information requests.
Get started
Ready to match your financial infrastructure to your therapy's complexity?
Schedule a discovery call with Archer. We'll show you what purpose-built NetSuite configuration looks like for cell and gene therapy organizations at your stage.