Drug synthesis

Logo_Logo-autres_CIRMThe CIRM has developed a great expertise in the design, synthesis, purification and structure elucidation of synthetic and natural pharmaceutical molecules such as new drug substances or new pharmacological tools.

We are accredited by the FAMHP for the analysis of plant materials, herbal medicines and drug substances (GMP label). We are part of the European network of Official Medicines Control Laboratories (OMCL), led by the European Department of the Quality of medicines (EDQM).

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

 

  • Chemical library (>5.000 in house compounds available for biological screening)
  • Organic synthesis of small molecules & heterocyclic compounds
  • Drug hemisynthesis from natural products
  • Small to large scale compound purification
  • Chiral resolution of racemic compounds
  • Determination of physicochemical properties and complete characterization of organic compounds by spectral and elemental analyses
  • Bio-guided isolation and structural determination of natural substances
  • Preparative isolation of natural products at the gram scale (prepHPLC, prepCPC, prepTLC)
  • Lab scale extraction of natural products
  • Full classical organic synthesis equipment
  • Microwave reactor
  • Nuclear Magnetic Resonance (NMR) 500MHz (equipped with a TCI cryoprobe and a LC-SPE system)
  • IR
  • Circular Dichroism
  • Mass Spectrometry
  • HPLC for spectral analysis and purity control
  • GC for elemental analysis
  • UV/DAD detector
  • Preparative chromatography on classical and chiral columns
  • HPLC preparative columns packing systems (Grace ModCol® Spring®)
  • Preparative CPC KROMATON (centrifugal partition chromatography)
  • Supercritical CO2 extractor (SUPREX)

Radiopharmaceutical development & production

Logo_Logo-autres_CRC_2Our team at CRC constantly develops faster, cheaper and safer techniques to prepare PET tracers. As a result, more convenient methods to introduce 18F on organic compounds were developed and patented.  Thanks to these technical developments, we are now able to produce multiple high-quality 18F based tracers suitable for clinical studies (GMP facilities). Some recent molecular imaging technologies require more elaborated radiolabeled compounds (e.g. peptides, proteins, oligonucleotides, lipids…) facing significant stability issues and side reactions. To tackle this increasing problem, we have developed a library of small 18F labelled compounds (prosthetic groups), which can be easily conjugated to biomolecules specific to the targeted biological process.

See here below for the different services we can provide:

We can assist you in:

  • The development of new labelling strategies
  • The development of complex 18F radiobiopharmaceuticals
  • The transfer of radiosynthesis from lab to GMP conditions and its validation
  • The drafting and preparation of an Investigational Medical Product Dossier (IMPD)
  • The GMP production of radiopharmaceuticals with complete and validated control

We have Marketing Authorization Application (#BE241132) for 18F-FDG (GLUCOTRACE).

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

  • Cyclotron IBA 18/9 for the production of Carbon-11 and Fluor-18
  • 9 classified rooms (A to D) GMP-monitored
  • 6 shielded cells: 4 class C for the synthesis and 2 class A for the dispensing
  • Independent quality assurance (QA) department

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

Our manufacturing processes are performed in compliance with the European quality standards applied in the pharmaceutical industry, including the European Pharmacopoeia (PhEUR) and the EUDRALEX rules and regulations (GMP and GLP).

Formulation

Picture_FormulationThe CIRM has expertise in small and large molecule formulation development. It is the first academic department in Europe that has obtained the GMP label. Furthermore, we obtained Federal Agency for Medicines and Health Products agreement since 1997. Our in-depth knowledge and in-house equipment allow us to develop and design a wide variety of dosage forms and drug delivery systems.

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

  • Development and evaluation of new drug formulations to ensure the delivery of a stable, pure and high-quality product, based on the physicochemical properties of your API
  • Standard and innovative formulations for NCEs
  • Optimization of existing formulations
  • Set-up of process development for selected dosage forms
  • Development and optimization of new pharmaceutical process technologies such as hot-melt extrusion or supercritical fluids technology
  • Improvement of API aqueous solubility
  • Improvement of the delivery of existing dosage forms through novel formulations
  • Characterization of pharmaceutical dosage forms

Analytical Platform

Being the first academic department in Europe with a GMP label, the CIRM can provide professional expertise with highly-equipped laboratories to support the development, robust optimization and validation of analytical and bioanalytical methods following ICH/FDA recommendations, such as:

Analytical platform

  • Identification and assay of API and related substances
  • Realization of USP and BP monographs
  • Drug quality control for synthetic drug and therapeutic macromolecules at each step of drug development (synthesis, purification, formulation, API and finished products)

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

  • Identification and assay of API(s) of the pharmaceutical formulation as well as assay of related substance
  • Realization of USP, EP and BP monographs
  • Drug quality control for synthetic drug and therapeutic macromolecules at each step of drug development (synthesis, purification, formulation, API and finished products)

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

  • In-process control with non-destructive methods
  • Development of microfluidic methods (high-sensitive system with low consumption of reagents and sample)

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

Stability testing is performed after storage in defined conditions according to standard and accelerated ICH conditions. All storage rooms are fully-controlled with 24/7 monitoring and alert systems allowing to test different range of storage conditions.

Our services include:

  • Support in designing studies for real-time
  • Development and validation of “stability indicating methods”
  • Examination of stability-relevant parameters (temperature – humidity)
  • Interim reports for every testing period
  • Comprehensive final report

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

We have extensive knowledge and expertise in developing and validating methods for raw materials, API’s, finished products and biological samples.

Once validated, method transfer will involve comparative testing, co-validation between two sites (Lab-to-Lab), complete or partial revalidation and comprehensive documentation.

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  • In vitro dissolution (USP method 1, 2 and 4)
  • Hardness, friability and disintegration time
  • Compression properties of powders

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  • In vitro dissolution (USP methods 1, 2 and 3)
  • Hardness, friability and disintegration time
  • Flow properties of powders
  • Particle size analysis
  • Thermal analysis
  • Viscosity analysis
  • Water content determination

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

To support the rapidly developing biopharmaceutical market, we provide a wide range of services to complement our pharmaceuticals services:

  • Enantiomeric separation and enantioselective assay of chiral drugs
  • Reference standard qualification
  • Analytical integrated systems (TAS) for bio-analysis
  • Peptides/proteins LC retention behavior analysis
  • Protein interactions in native forms
  • Chiral recognition patterns and interactions
  • Protein/protein interactions
  • Protein post-translational modifications
  • Drug metabolisms
  • Drug/protein interactions
  • Poor quality medicines and counterfeit product evaluation
  • Vibrational spectroscopy and imaging (NIR, Raman, SERS and Raman imaging)
  • Surface enhanced Raman scattering (SERS)
  • Chemometrics

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.

Separation & detection techniques:

  • Liquid chromatography (HPLC, UHPLC, micro-LC, nano-LC and LC-Chip with UV, MS, MS/MS and ion-trap detection)
  • Capillary electrophoresis (CE) with UV and LIF detection
  • Supercritical Fluid Chromatography (SFC) with UV and MS detection
  • Gas chromatography (GC) with FID detection

Spectroscopic techniques:

  • Atomic absorption spectrometers: flame and graphite furnace
  • Fourier Transform Infrared (FT-IR), Near-infrared (NIR), Raman spectrometers
  • Raman confocal microscopy
  • Vibrational spectroscopy and imaging: Near Infrared spectroscopy (NIRS), Raman and surface enhanced Raman spectroscopy (SERS)

Contact [info@b2h.be] us to discuss how these capabilities can forward your projects! We will help you develop tailored solutions.