Contract manufacturing
Repeat-batch and scale-up production of validated organic chemistries, from kilo-scale specialty intermediates to forward-planned hundred-kilo programs, under a fixed-price supply agreement. Built for customers who have proven a chemistry at lab scale and now need a reliable, sovereign Australian source rather than another procurement experiment.
Who it's for
Contract manufacturing is the right path when you have:
- A validated chemistry, the route is known, intermediates are characterised, and the molecule is no longer a research question
- A recurring demand profile, multiple batches per year, or a forward-planned ramp from kilo to tens of kilo
- A need for sovereign supply, the program can't tolerate the freight, lead time, or geopolitical risk of an overseas vendor
What we do
NPL operates a Brisbane organic-synthesis facility built for repeat-batch production rather than one-off discovery work. Each program runs against a documented Master Batch Record, produced to a Customer Specification Agreement, and tracked at lot level. Output ships with full per-lot documentation: COA, NMR, GC and/or HPLC, SDS, and a Batch Production Record on request.
Production chemistries we currently scale: furan-platform monomers and amines, maleimide and bis-maleimide crosslinkers, specialty amines and sulfonamides, and Diels-Alder building blocks. Other chemistries are accepted subject to an internal feasibility & safety review.
How we engage
Engagement starts with a Master Supply Agreement covering scope, pricing schedule, capacity reservation, IP terms, change-control, and exit. Individual batches are then released against firm purchase orders or a rolling forecast, whichever model fits your planning cadence.
For chemistries that haven't yet been validated at NPL, the program begins with a SV-01 Custom Synthesis tech-transfer batch before transitioning to recurring supply.
Long-term programs can reserve dedicated reactor weeks against an annual forecast. Reservations carry a small standby fee and lock in priority over spot work, useful when downstream production schedules cannot absorb a delay.
Once a chemistry is locked, no route, reagent-source, or specification change is made without written customer approval. This is the difference between a contract manufacturer and a job shop, and the reason primes can use our output without re-qualifying every lot.
Capacity ladder
Lab-scale
Today's posture. Glass and small jacketed reactor work, full analytical coverage in-house, lead times of 2-6 weeks per batch.
Pilot-scale
Dedicated 50 L jacketed reactor train commissioning under our Brisbane facility expansion. Suits programs ramping past clinical / qualification volumes.
Production-scale
Production reactor train tied to anchor program throughput. Subject to off-take commitment and capacity reservation. Site-engineered against IChemE / AS standards.
Engagement model
Framework terms
Single bilateral agreement covering scope, pricing schedule, lead times, capacity reservation, IP, change-control, audit rights, and exit. Negotiated once, valid 12-36 months.
- Scope & specification
- Pricing schedule by tier
- Capacity reservation (optional)
- Change-control protocol
- Audit & QMS access
Per-batch execution
Individual lots released against firm POs or a rolling forecast. NPL confirms reactor-week, runs the Master Batch Record, and ships to the agreed specification & documentation set.
- Firm-PO or rolling-forecast model
- Master Batch Record per lot
- Per-lot COA, NMR, GC, SDS
- Batch Production Record on request
- Quarantine & release-to-customer
Quality & documentation
| Document | Frequency | Issued by | Retained |
|---|---|---|---|
| Certificate of Analysis | Per lot | NPL QC | 7 years |
| NMR (¹h, ¹³c) | Per lot | NPL Analytical | 7 years |
| GC / HPLC purity | Per lot, where applicable | NPL Analytical | 7 years |
| SDS (GHS Rev 7) | Per product, on revision | NPL Regulatory | Indefinite |
| Master Batch Record | Per chemistry, on change | NPL Operations | 10 years |
| Batch Production Record | Per lot, on request | NPL Operations | 7 years |
| Change-control notification | Per scope change | NPL QA | Customer-side |