OVERVIEW

Symbiotec’s R&D uses State-of-the-art Technologies to develop new Generic APIs and innovative and optimized processes for our existing products. Our mission is to create compliance-focused regulatory processes for pharmaceutical products and fully backward integrated to serve diverse markets worldwide.

The R&D team is composed of highly qualified scientists, including post-doctorates, Ph.D. holders, and post-graduates. The team is dedicated to developing complex APIs using chemical synthesis, biotechnology, analytical, regulatory, and intellectual property expertise.

Our team constantly keeps focusing on the economic viability, robustness, and scalability of processes. We also work in collaboration with International Research Institutions that boost our research capabilities.
Symbiotec swears by green chemistry and has been a frontrunner in fields like biotransformation, bio-catalysis, and fermentation, offering their best care to the environment for over a decade.

CHEMICAL SYNTHESIS

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Key Areas

  • Analytical Development
  • Process Development
  • Scale-Up
  • Troubleshooting

Key Equipments

  • HPLC & UPLC
  • LCMS
  • ICPMS
  • Preparative HPLC
  • Photo Reactor
  • GC Gas Chromatography with FID AND TCD Detector

Skills

  • Cryo reaction
  • Hazardous Reactions
  • Product extraction and purification
  • Hydrogenation
  • Photo-reactions
  • Flow Chemistry
  • Lyophilization
  • Spray Drying

BIOTECHNOLOGY

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Key Areas

  • Molecular Biology
  • Fermentation
  • Process Technology
  • Product Recovery
  • Assay Development

Skills

  • Cell Banks (MCB/ WCB): Preparation and Maintenance
  • Strain Improvement
  • Fermentation Development
  • Downstream Development: Product Extraction and Purification
  • Gene Cloning and Expression

Key Equipments

  • Real Time PCR
  • Nucleic Acid Extractor
  • HPLC’s
  • BOD’s/ Incubators
  • Microscopes (Phase Contrast/ Fluorescent/ Stereomicroscope)
  • Biosafety Cabinets Class II
  • Lab Fermenters
  • High Speed Cryo Centrifuge
  • Spectrophotometers (Nanodrop)
  • Gel Documentation System
  • Ultasonicator

API TECHNICAL SERVICES

Symbiotec supports all its contracted customers with activities at any development stage and scale of synthesis required to be cGMP compliant.

We offer:

  • Analytical Method Development & Validation
  • Process Validation
  • Cleaning Validation
  • Batch Release
  • Characterization of Solid-state Properties (Polymorphism, Particle Size Distribution, etc.)
  • Execution of ICH Stability Studies
  • Proof of API Structure
  • Identification of Impurities
  • Preparation of Analytical Reference Standards
  • Regulatory Filing Support
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ANALYTICAL SUPPORT

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VALIDATION SUPPORT

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REGULATORY SUPPORT