DIAGNOSEX is a contract development and manufacturing organization for peptide APIs and new chemical entities. We support pharmaceutical and biotechnology companies across the full product lifecycle — from early feasibility and CMC development through GMP manufacturing of clinical and commercial drug substance, to aseptic fill–finish in packaged vials.
A cross-section of the molecules produced through our development and GMP pipeline — from GLP-1 metabolic programs to specialty research peptides — all supported by the same process, analytical and fill–finish platforms.
From research synthesis to commercial manufacturing, with integrated analytical, purification and fill–finish services at every phase of development.
Comprehensive CMC support for your peptide or NCE program — route scouting, process development, analytical method validation and IND-enabling documentation.
GMP manufacturing of peptide drug substance and drug product at scales from pilot batches to multi-kilogram commercial supply, with full batch documentation.
Sequences to 50+ residues synthesized to your specification — modified residues, cyclization, disulfide mapping and conjugation, from milligram reference standards upward.
Lyophilization cycle development and aseptic filling, stoppering and crimping — delivered as powder, solution or suspension in 2–30 mL vial formats.
ICH Q2-validated methods for release and stability — RP-HPLC, LC-MS, ion-exchange, residual solvents, endotoxin and moisture, with stability-indicating assays.
GMP quality systems, IQ/OQ/PQ qualification files, CofA and batch records, plus regulatory support for IND submissions and DMF-ready documentation.
We design and build the same process platforms we operate for your program — which means deeper process understanding, faster troubleshooting and one accountable partner at every stage.
Method development, preparative purification, fluid handling, lyophilization and aseptic fill–finish under one quality system — no interface risk between vendors.
Our DAC800 preparative chromatography, dosing and freeze-drying platforms are the same equipment we supply to GMP plants worldwide — operated by the engineers who build them.
Every program ships with GMP documentation built for regulatory review — validated methods, qualification protocols and complete batch genealogy.
Whether you need a peptide for a physician-sponsored IND, a corporate IND or large-scale commercial manufacturing, we tailor capacity and documentation to your phase of development.
We offer flexibility in production scale — initial gram quantities for early studies through commercial requirements of multi-kilograms per batch.
| Scale tier | Batch range | Typical use | Grade |
|---|---|---|---|
|
Lab |
1 mg – 10 g |
Reference standards, feasibility, assay development |
Research |
|
Pilot |
10 g – 1 kg |
Tox batches, clinical supply, process validation |
GMP |
|
Commercial |
1 kg → multi-kg |
Phase III and commercial API manufacture |
GMP |
We partner with innovators at every stage — from discovery labs to commercial manufacturers.
Research-grade peptides and small GMP batches for investigator-initiated studies.
Full CMC outsourcing — one partner from feasibility through first-in-human supply.
Research-grade peptides and small GMP batches for investigator-initiated studies.
Full CMC outsourcing — one partner from feasibility through first-in-human supply.
A predictable, milestone-based engagement model — you always know what is being delivered, when, and against what acceptance criteria.
Share your molecule and requirements — a program manager will respond with a scoping call and a fixed quotation.
