info@chemengine.co.in
Admin Login

Seamless Chemical Scale-Up

Reliable Mg to Kg Synthesis for Global Pharma Development.

Request Scale-Up Proposal Schedule Facility Tour

ChemEngine Pharma Solutions Pvt. Ltd. – Milligram to Kilogram Scale-Up Division

ChemEngine Pharma offers seamless, flexible scale-up synthesis capabilities designed to transition chemical entities from early discovery milligrams to process-validated kilogram batches. Our integrated facilities bridge the gap between medicinal chemistry and commercial manufacturing, ensuring batch-to-batch consistency, process safety, and strict regulatory compliance at every stage of development.

Integrated Scale-Up Capabilities

Milligram Scale
1 mg – 100 g

Hit identification, early SAR exploration, high-throughput library synthesis, and initial assay validation emphasizing speed and structural diversity.

Gram Scale
100 g – 1 kg

Preclinical evaluation, non-GLP toxicology studies, formulation testing, and initial route optimization utilizing benchtop reactors.

Kilogram Scale
1 kg – 100+ kg

GLP toxicological studies, Phase I/II clinical trials, dynamic scale-up validation, and intermediate production in pilot plant vessels.

Process Chemistry
Optimization

Route re-design, heat/mass transfer assessments, hazard evaluations, and comprehensive raw material cost reduction strategies.

Production Scale & Infrastructure Matrix

A clear roadmap of our capacities, equipment, and analytical deliverables.

Scale Stage Batch Range Vessel Capacity Analytical & QC Package Primary Purpose
Discovery & R&D 1 mg – 100 g Lab glassware (10 mL – 5 L) 1H-NMR, LC-MS, HPLC, COA Initial SAR, target screening
Pilot Development 100 g – 1 kg Glass reactors (10 L – 50 L) Full spectroscopic package, chiral purity, Karl Fischer Tox studies, formulation development
Kilogram Production 1 kg – 100+ kg Stainless steel / Glass-lined (100 L – 2000 L) Process validation, ROI, heavy metals, residual solvents, full COA Clinical trials, API intermediates

Safety & Process Engineering

Transitioning from bench to pilot scale requires meticulous engineering. Our experts prioritize inherently safe processes.

  • Advanced Thermal Hazard Assessments: Rigorous runaway reaction testing and thermal stability data mapping using Reaction Calorimetry (RC1/DSC).
  • Robust Tech Transfer: Seamless scale-up with complete batch records, SOPs, and process validation documentation.
  • Compliance-Driven Infrastructure: Flexible batch processing operating under stringent ISO and cGMP-aligned quality systems within walk-in fume hoods.
Consult an Engineer
Process engineer analyzing data
Walk-in scale-up fume hood

Packaging, Quality & Logistics

Safeguarding product integrity from our loading dock to your laboratory.

Analytical Instruments HPLC
Absolute Quality Control

Every scale transition is accompanied by a complete analytical dossier. High-purity instruments (HPLC, GC-MS, NMR) ensure that kg-scale batches perfectly match the impurity profiles of initial mg-scale discoveries.

Logistics and Drums
Secure Global Logistics

From UN-certified tamper-evident drum containers for bulk material to temperature-controlled storage facilities, we offer integrated cold-chain and hazardous materials shipment capabilities globally.