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Operant Scientific
GMP-compliant API production

Multi-tonne API supply, audited every quarter.

Our manufacturing plant runs multi-step synthesis, catalytic hydrogenation, cryogenic reactions, and standard unit operations up to 500L pilot and multi-tonne commercial scale — with in-line QC and stability chambers under ICH Q1B.

Pilot scale
Up to 500 L
Commercial scale
Multi-tonne annualised
Unit operations
Hydrogenation · cryogenic · distillation · crystallisation
QC coverage
24/7 in-line + release testing
Process

Five stages from brief to delivery.

Timelines vary by molecule and scope; the shape below applies to every engagement.

  1. Step 01

    Raw material qualification

    Vendor audit + CoA verification before every campaign.

  2. Step 02

    In-process control

    HPLC and GC checks at every unit operation.

  3. Step 03

    Isolation

    Crystallisation, filtration, drying under controlled conditions.

  4. Step 04

    QC release

    Full analytical panel per approved specification before release.

  5. Step 05

    Ship & document

    Client-facing CoA, batch record excerpt, and CoS on shipment.

Equipment & governance

The specific tools, standards, and headcount.

Reactors & unit operations

  • Glass-lined reactors×8

    50–5000 L range with jacketed control

  • SS316L reactors×4

    Cryogenic and pressure capability

  • Nutsche filter dryers×3

    Automated cake wash and drying

  • Hydrogenation autoclave×2

    Up to 20 bar, Pt/Pd/Ni catalysis

Analytical suite

  • HPLC systems×12
    USP <621>
  • GC / GC-MS×5
    USP <467>
  • LC-MS / NMR×3

    Impurity ID and structural confirmation

  • ICH stability chambers×6
    25/60, 30/65, 40/75 + photostability
Representative case

One example, real numbers.

Recent engagement

Tonne-scale commercial supply, first-pass QC 99.6%.

Steady-state commercial supply on a validated 4-step synthesis. Zero out-of-specification releases in the last 24 months.

Scale
1.2 t/year
Markets
6 countries
Duration
24 months steady
First-pass
99.6% QC
Read the full caseRepresentative case — full attribution under NDA.

API manufacturing — capability deck

A ten-page PDF written by our subject-matter lead for this capability. Delivered by email within one business day, always signed by a director.

  • Multi-step synthesis with catalytic hydrogenation and cryogenic capability
  • In-line QC and full analytical release before every shipment
  • ICH Q1B stability program included with every campaign

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