We have established the cutting-edge infrastructure required for the development of both traditional and so-called highly potent (HP) drug substances. As for HP drug substances, our colleagues work completely separated from the substances and use special gloves to manipulate the instruments and equipment — which is placed in transparent, closed isolators. The modern isolator setup ensures a convenient and safe working environment, while we protect our environment with a closed system of waste collection and elimination.

Our manufacturing processes and activities fully comply with cGMP principles.

Our facilities have successfully undergone comprehensive audits and received accreditation from key regulatory authorities, including FDA (USA, first in 1976), PMDA (Japan), EDQM (EU) and Hungarian authority.

Our services:

Chemical Research

• Route scouting & selection
• Synthesis development – batch & flow platform
• Process optimization: reaction conditions, solvent, catalyst optimization
• Impurity determination & standard supply
• Polymorph and salt selection
• Support of in-house and partner's drug product projects

Chemical Process Development

• Scale-up to maximum 20 L volume
• Process optimization: quality, yield, cost, safety, scalability
• Risk evaluation – ICH Q11
• Production of intermediates and drug substances (100 g − 2 kg)

HP Drug Substance Development

• 1 g/m³ < OEL < 10 g/m³ (OEB4)
• Synthesis development and scale-up to maximum 15 L volume
• Polymorph and salt selection
• Process optimization: quality, yield, cost, safety, scalability
• Risk evaluation – ICH Q11
• HP API production for formulation experiments, clinical trials and commercial purposes
• Manufacturing under cGMP – ICH Q7

Chemical Process Engineering Laboratory

• Process development of physicochemical unit operations: crystallization, filtration, drying, milling
• Reaction calorimetry
• Process transformation from batch to flow platform

Drug Substance Pilot Plant

• Quick and flexible process development from kilolab up to plant scale
• Production of materials for
  • toxicity testing
  • formulation experiments
  • safety and stability studies
  • clinical trials
  • commercial batches
• Production of APIs under cGMP regulations
• Non-HP: 5-50 kg batch size, HP: 5-20 kg batch size
• Highly Potent Drug Substance GMP production line
  • 1 _g/m³ < OEL < 10 _g/m³ (OEB4)
  • annual capacity: ca. 600 kg drug substance
  • handling solid HP substance in isolators
  • isolated production areas by airlocks
  • disposed effluent gases
  • dedicated sewer & waste handling

Drug Substance Analytical Development 

• Analytical development and quality control (QC) in non-GMP and GMP environment
• Liquid- and solid-state NMR measurements
• Structure determination by single crystal XRD
• Analytical method development (purity and assay testing, impurity identification, reaction kinetics, in-process tests, etc.)
• Analytical support of drug substance technology development
• QbD/Design space support (analytical data support to statistical models)
• Validation of analytical methods – ICH Q2(R1)
• Stress tests and forced degradation studies
• Stability studies – ICH Q1A(R2)
• Determination of quality requirements
• Genotoxic impurities – ICH M7
• Elemental impurities – ICH Q3D
• Elaboration of CTD 3.2.S modules – ICH M4
• Batch release of BE and registration batches
• Drug substance and intermediate storage testing
• HP Analytical Laboratory
  • dedicated infrastructure for HP intermediates and drug substances

Intellectual property (IP) support

Contact us at pharmaservices@egis.hu or fill the form below.

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