Manufacturing
Beyond The Science
Manufacturing
Production system in compliance
with Global GMP requirements
with Global GMP requirements
- 01 compliance with GMP process from warehousing to release of API
- 02 compliance with KGMP, EuGMP, cGMP requirements
Manufacturing
Small API ServiceSmall scale synthesis
- Route scouting
- Feasibility studies
- Synthesis of compounds in mg/g scale
- Metabolite synthesis
- Preparation of standards / reference substances
- Impurity profiling
- Impurity reference synthesis
- Synthesis of stable isotope labelled substances
Contract manufacturing and analytical services
- cGMP manufacturing of APIs and key intermediates
- Analytical method validation
- Process validation
- Full CMC package
- Drug master files: compilation, maintenance
- Comprehensive documentation
API process development & scale-up
- Design of experiments (DoE)
- Chemical process development
- Process scale up
- Process optimization
- Analytical method development
Smart Automation System
Control
- - Reactor, Extractor, precipitation reactor (operation, temperature/vacuum etc.)
- - HVAC and Utility
Monitoring
- - Temperature/humidity and room differential pressure of Production building, laboratory
Data Management
- - Data collection and management with data integrity
GMP Pilot Manufacturing
- 2 independent production units
- Reactor volume from 50 to 200 L
- Operation temperature: -30 °C – +180 °C
- 74L vacuum dryer
- 172L Dryer
-
Line 1
-
Line 2
Laboratory
- Agilent HPLC systems with UV detectors
- GC systems with FID detector and automatic liquid/Head-Space sampler
- FT-IR spectrometer with diamond ATR accessory
- Karl Fischer titrator
- UV-spectrophotometer
- High sensitivity polarimeter
- Melting point apparatus
- Stability study chambers
- TOC Analyzer
- pH meter
- Conductivity meter
Manufacturing Equipment
| Equipment Name | Model No. | Material |
|---|---|---|
| 50L Reactor | RE-102 | Hastelloy |
| 200L Reactor | RE-202 | Hastelloy |
| 50L Crystallizer | CR-101 | Hastelloy |
| 200L Crystallizer | CR-201 | Hastelloy |
| 50L Extractor | RE-101 | Hastelloy |
| 200L Extractor | RE-201 | Hastelloy |
| Nutsche Filter(10L) | NF-101 | SUS316 |
| Nutsche Filter(10L) | NF-102 | SUS316 |
| Nutsche Filter(70L) | NF-201 | SUS316 |
| Nutsche Filter(70L) | NF-202 | SUS316 |