Customized research

 

SYNTHESIS

Capabilities in the field of chemical synthesis.

Synthesis

IDENTIFICACTION

Structural elucidation studies.

Identificaction

TOOLS

Tools and Biotechnology Research.

Tools

CHARACTERIZATION

Characterization and identification of impurities.

Characterization

 

A.D. RAW MATERIALS

Analytical development for raw materials and pharmaceuticals.

A.D. Raw materials

A.D. PHARMACEUTICALS

Development of pharmaceuticals.

A.D. Pharmaceuticals

A.D. COSMETICS

Analytical development for cosmetics.

A.D. Cosmetics

A.D. PLANT EXTRACTS

Analytical development for plant extracts.

A.D. Plant extracts

 

PHARMACEUTICAL P.

Development of pharmaceuticals.

Pharmaceutical products

COSMETIC P.

Development of cosmetics.

Cosmtic products

PIPELINE

Analytical development for cosmetics.

Pipeline

COMMERCIAL MODEL

Business model. Collaboration and support.

Commercial model

COMMERCIAL MODEL

 

InKemia IUCT group works with companies under contract by helping them develop their projects, either focusing in obtaining products that are commercially attractive, solving production problems or developing new processes.

The collaboration modalities go from specific projects developed in a limited period of time to signing a contract that allows collaboration in different projects for a long period of time, 1 or 2 years, allowing more flexibility to introduce new ideas as they appear. Theses modalities are based in the application of working groups in full time equivalent that allow us to adjust to each project’s individual needs. All the intellectual property rights or technical knowledge derived from the project belong to the client from the moment the contract is signed.

Another option to consider is the execution of projects in collaboration mode. In this option there are two possibilities: the first one consists in looking for financing by requesting it from programs that aid R+D, the second one consists in the client and InKemia IUCT group sharing the risk that executing the projects represents. In this last option, in case of success, both parts share the profit and the intellectual property must be negotiated as part of the deal.

InKemia IUCT Group can also licence part of its patented technology. The commercial terms in this option are subject to studying each case.

InKemia IUCT Group is always open to different possibilities and proposals form the companies. Two of our most important values are flexibility and the capacity to adapt ourselves to our client’s needs.

 

 

SYNTHESIS

InKemia IUCT group has the following capacities in the Chemicals synthesis sector:

Medicinal chemistry

  • Design and synthesis of new chemical entities (Hit-finding)
  • Design and synthesis to obtain libraries by parallel synthesis
  • Hit to lead and lead optimization
  • Optimization of synthetic routes and scale up

Custom Synthesis

  • Synthesis of building blocks and non commercial scaffolds
  • Synthesis of patterns and impurities
  • Synthesis of reference compounds and metabolites

New Synthetic Routes

  • Set up of new synthetic routes
  • Design of new synthetic routes that are not published or patented
  • Experimental design and optimization of chemical synthesis: yields, selectivity, crystallization and impurities.
  • Minimization of synthesis steps and isolations
  • Design and synthesis of new compounds
  • Generation reduction of toxic and dangerous by-products
  • Processes without salt generation
  • Processes without solvents
  • Development of processes with minimum solvent consumption
  • Optimization of the synthesis methodology in both solid and liquid phase
  • Safer reactive compounds

Optimization of chemical processes

  • Optimization of processes using LABMAX (kilolab) automatic reactor
  • Cost reduction by redesigning of synthetic processes
  • Substitution of dangerous reactive compounds
  • Development of validation processes and scale up

 

Revaluation of industry’s by-products

  • Use of by-products as raw material for new processes
  • New applications for industrial by-products

 

Structural Elucidation Studies

  • Structural elucidation studies 


Chemical biotransformation

  • Chemical synthesis using microorganisms
  • Fermentation processes
  • Biotechnological processes for chemical products of large tonnage (biopolymers, solvents, bio monomers) and fine chemistry
  • Obtention of novelty enzymes as industrial biocatalysts for fine chemistry and large productions
  • Development of minimal and artificial microorganisms: synthetic biology

Alternative Solvents

  • Solvent substitution
  • Development of new solvents with low toxicological profile for industrial use
  • Synthesis of active principals with safe solvents
  • New uses for alternative solvents

 

Instrumental Techniques

 

  • LABMAX (kilolab) automatic reactor
    • Reactor with computerized control of the reaction variables: temperature of the reaction, temperature of the jacket, agitation speed, flow of the reactive addition, pH control, control probes, distillation control.
    • Reactor from 1-3 L, also pressure reaction up to 1 litre.

 

  • Gas Chromatography- Flame Ionization Detector (GC-FID)
  • Gas Chromatography Mass Spectrometry (GC-MS)
  • Gas Chromatography, Head Space
  • HPLC-UV
  • HPLC, Mass Spectrometry (MS)
  • Flame Atomic absorption spectroscopy
  • Graphite furnace atomic absorption spectrometry
  • FT-IR
  • molecular absorption spectroscopy, UV-Visible
  • NMR (400 MHz)

 

ISOLATION, IDENTIFICATION AND CHARACTERIZATION OF PRODUCTS AND STRUCTURAL ELUCIDATION

InKemia IUCT Group offers services of isolation, identification and characterization of the following products, among others:

  • Impurities of pharmaceutical products
  • Natural products
  • Fractions of natural products extracts
  • Additives

 

Isolation

  • Product purification
  • Liquid-liquid extraction
  • Preparative HPLC
  • Preparative TLC
  • Chromatographic column
  • Solid phase extractions

Analytical techniques for characterization

  • Elemental analysis
  • NMR proton spectrum, carbon, HSQC and HMBC, COSY and NOESY
  • Exact mass spectrum
  • FTIR spectrum
  • MS/MS spectrum

Structural Elucidation

  • Acquisition of spectrums, interpretation, formulation of hypothesis and data verification.

BIOTECHNOLOGICAL RESEARCH

The main areas of development in industrial biotechnology of InKemia IUCT group are:

  • New microorganism prospects and enzymes derived from extreme environments
  • Obtention of novelty enzymes as industrial biocatalysts to be used in the fine chemistry sector or related.
  • Purified expression of proteins
  • Design and optimization of biocatalysts
  • Design of biocatalyst processes
  • Scale-up studies for biotechnological processes

 

Techniques of specialization:

 

  • Cloning of host cells both prokaryotic and eukaryotic
  • Cloning of vectors
  • Constitutive and inductive expression of proteins in prokaryotes and yeasts
  • Primer design
  • Set-up of biotransformation reactions mediated by microorganisms or purified fractions of microorganisms.
  • Biosynthesis of APIs both antiviral and anti-cancer
  • Biosynthesis of monomers and vitamin K3
  • Purification of products and metabolites
  • Identification of Products and metabolites
  • Creation of fusion proteins
  • Quantitative and qualitative determination of DNA, RNA and proteins
  • Ames Test

DEVELOPMENT OF PHARMACEUTICAL PRODUCTS

InKemia IUCT group counts with authorized facilities by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (Spanish Agency for medicinal drugs and Sanitary Products) to produce pharmaceutical products. The manufacturing and quality control practices performed at InKemia IUCT group are according to GMP guidelines.

 

We have the following accreditations: 

  • ISO 9001:2008 certification for the design, research and development of new products, control systems and training for the pharmaceutical, alimentary, chemical and related sectors (Nº SGI 3201316). Certification by Lloyd’s Register
  • Authorization by the AEMPS to manufacture and perform quality control in medicinal drugs for human consumption since 2004 (Nº 4155-E)
  • Authorization by the AEMPS to manufacture and perform quality control in veterinary medicinal drug since 2012 (Nº 4155-E)
  • Authorization by the AEMPS to manufacture and perform quality control in medicinal under research since 2012-(Nº 4155-E)

 

The activities that we can develop are:


Galenic Development

  • Pre-Formulation studies including:
  • Chemical and physical characterization of APIs
  • Compatibility studies between excipients
  • Preservative challenge test
  • Anti-oxidative efficacy studies
  • Hygroscopicity studies
  • Lubrication impact in solid products
  • Formulations development
  • Formulations optimization
  • Formulations for stability
  • Comparison of dissolution profiles
  • Batch Productions at pilot levels
  • Support in technological transfers

Production

  • Production of solid, semisolid and liquid (non-sterile) pharmaceutical products.
  • Production of medicinal products under research
  • Production of veterinary medicinal products
  • Support in studies for process validation

 

Quality Control

  • Physicochemical and microbiological control of cosmetic and pharmaceutical products
  • Microbiological control of sterile areas
  • Development and set-up of analytical methods
  • Validation of physicochemical and microbiological analysis methods
  • Analytical support in validation of processes and cleaning


Stability studies under ICH conditions

  • Product storage according to ICH regulations
  • Product testing
  • Development of study protocol
  • Preparation for the study report

Consultancy

  • DMF Development
  • Experimental support
    Structure and drafting
  • Support in applications that require commercial authorization
  • Support for GMP implementation
  • Support for GLP implementation


Synthesis of APIs

  • Chemical and biochemical development and scale up for APIs synthesis
  • Validation and scale up studies
  • Synthesis optimization
  • APIs characterization
  • APIs stress test
  • Isolation, characterization and synthesis of degradation products

Facilities

  • Manufacturing pilot plant (GMP)
  • Laboratories for physicochemical quality control
  • Laboratories for microbiological quality control
  • Laboratories for the chemical development and biochemical synthesis of APIs

 

Manufacturing Facilities

The manufacturing facilities at InKemia IUCT group include ISO7 and ISO8 rooms for the production of solid, semisolid and non sterile liquid pharmaceutical products. The equipment in these facilities includes “V” mixer, rotating compressor, fine coating machine, blister machine, drying ovens, liquid and semisolid reactor, and laminar flow cabin.

 

Quality control laboratory

Instrumental analysis techniques:
FT-IR, UV-diode array, UV-VIS, polarimeter, HPLC-MS3, GC-FID, GC-MS, MS, HPLC-UV, HPLC-diode array, atomic absorption (flame+hydride and graphite furnace)

Other equipment and techniques:
Solution test, digesters, drying ovens, moulding, automatic titration, viscometer, hardness testers, disintegration tests, friability tester, microscopes, laminar flow cabins, incubators, filtering systems.

 

Chemical synthesis laboratory

The equipment includes, among others, solid-phase parallel synthesizer, liquid-phase parallel synthesizer (carrousel system), parallel synthesizer (IR incubator), Lab-Max reactor, flash parallel purification system, centrifugal evaporator, HPLC-MS-NMR (400 MHz). 

Biotechnological synthesis laboratory

The equipment includes, among others, thermal cycler, agarose gel electrophoresis equipment, polyacrylamide gel electrophoresis equipment, laminar flow cabin, bioreactor, incubator.

 

DEVELOPMENT OF COSMETIC PRODUCTS

InKemia IUCT group counts with authoruized facilities by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Sanitarios (Spanish Agency for medicinal drugs and Sanitary Products)   to perform control of cosmetic products. The quality control practices performed at InKemia IUCT group are according to GMP guidelines.

We have the following accreditations:

  • ISO 9001:2008 certification by Lloyd’s Register for the design, research and development of new products, control systems and training for the pharmaceutical, alimentary, chemical and related sectors (Nº SGI 3201316).
  • Authorization by the AEMPS to perform quality control in cosmetic products since 2007 (Nº 4155-E).

 The activities that we can develop are:

Desenvolupament galènic

  • Pre-Formulation studies including:
  • Chemical and physical characterization of APIs
  • Compatibility studies between excipients
  • Effectiveness studies of antimicrobial preservation
  • Effectiveness studies of antioxidants
  • Hygroscopicity studies
  • Lubrication impact in solid products

  • Formulations development
  • Formulations Optimization
  • Stability Formulations
  • Comparison of dissolution profiles
  • Batch Productions at pilot levels
  • Support in technological transfers

Manufacturing

  • Support in Studies for process validation

 

Quality control

  • Physicochemical and microbiological control of cosmetic products
  • Start-up and development of methods for analysis
  • Validation of physicochemical and microbiological analysis methods
  • Analytical support in validation of processes and cleanliness



Stability studies under ICH conditions

  • Product storage according to ICH regulations
  • Product testing
  • Development of study protocol
  • Drafting of study report

 

Consultancy

  • Support in applications that require commercial authorization
  • Recommendation for GMP establishment
  • Recommendation for GLP establishment

 

Synthesis of APIs

  • Chemical and biochemical development and scale up for APIs synthesis
  • Validation and scale up studies
  • Synthesis optimization
  • APIs characterization
  • Isolation, characterization and synthesis of impurities and degradation products

 

Facilities

  • Manufacturing pilot plant (GMP)
  • Laboratories for physicochemical quality control
  • Laboratories for microbiological quality control
  • Laboratories for the chemical development and biochemical synthesis of APIs

 

Manufacturing Facilities

The manufacturing facilities at InKemia IUCT group include ISO7 and ISO8 rooms for the production of solid, semisolid and non sterile liquid pharmaceutical products. The equipment in these facilities includes “V” mixer, rotating compressor, fine coating machine, blister machine, drying ovens, liquid and semisolid reactor, and laminar flow cabin.

 

Quality control laboratory

Instrumental análisis techniques:
FT-IR, UV-diode array, UV-VIS, polarimeter, HPLC-MS3, GC-FID, GC-MS, MS, HPLC-UV, HPLC-diode array, atomic absorption (flame+hydride and graphite furnace)

Other equipment and techniques:
Solution test, digesters, drying ovens, moulding, automatic titration, viscometer, hardness testers, disintegration tests, friability tester, microscopes, laminar flow cabins, incubators, filtering systems.

 

Chemical synthesis laboratory

The equipment includes, among others, solid-phase parallel synthesizer, liquid-phase parallel synthesizer (carrousel system), parallel synthesizer (IR incubator), Lab-Max reactor, flash parallel purification system, centrifugal evaporator, HPLC-MS-NMR (400 MHz).

 

Biotechnological synthesis laboratory

The equipment includes, among others, thermal cycler, agarose gel electrophoresis equipment, polyacrylamide gel electrophoresis equipment, laminar flow cabin, bioreactor, incubator.

ANALYTICAL DEVELOPMENT FOR CHEMICAL PRODUCTS

InKemia IUCT group also counts with ISO 9001:2008 certification by Lloyd’s Register for the design, research and development of new products, control systems and training for the pharmaceutical, chemical, alimentary and related sectors (Nº SGI 3201316).

Physicochemical Methods

Development of analytical methods for the identification, purification and determination of concentration by means of:

  • Separation and characterization of impurities and degradation products
  • Set up and optimization of methods according to the client’s specific needs.

Validación de métodos con la determinación, entre otros, de los siguientes parámetros:

  • Problem solution stability
  • Accuracy
  • Repeatability (accuracy of the method)
  • Intermediate precision
  • Precision
  • Linearity
  • Selectivity
  • Robustness
  • Reproducibility
  • Detection Limit
  • Quantification limit

Microbiological methods

InKemia IUCT group performs the development and validation of the following microbiological methods:

  • Challenge test
  • Microbiological assay for vitamins, antibiotics...

 

Analytical Techniques

  • Gas Chromatography- Flame Ionization Detector (GC-FID)
  • Gas Chromatography Mass Spectrometry (GC-MS)
  • Gas Chromatography, Head Space
  • HPLC-UV
  • HPLC, Mass Spectrometry (MS)
  • Flame Atomic absorption spectroscopy
  • Graphite furnace atomic absorption spectrometry
  • FT-IR 
  • Molecular absorption spectroscopy, UV-Visible
  • NMR (400 MHz)Cromatografía de gases, espectrometría de masas(GC-MS)

ANALYTICAL DEVELOPMENT FOR COSMETIC PRODUCTS

InKemia IUCT group has been authorized by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (Spanish Agency for medicinal drugs and Sanitary Products) to perform quality control of cosmetic products (Nº 4155-E).

InKemia IUCT group also counts with ISO 9001:2008 certification by Lloyd’s Register for the design, research and development of new products, control systems and training for the pharmaceutical, chemical, alimentary and related sectors (Nº SGI 3201316).

Physicochemical Methods

Development of analytical methods for the identification, purification and determination of concentration by means of:

  • Separation and characterization of impurities and degradation products
  • Set up and optimization of methods according to the client’s specific needs.

Validación de métodos con la determinación, entre otros, de los siguientes parámetros:

  • Selectivity
  • Linearity
  • Accuracy
  • Precision
  • Robustness
  • Stability of the problem solution
  • Repeatability
  • Reproducibility
  • Detection Limit
  • Quantification limit

Microbiological methods

  • InKemia IUCT group performs the development and validation of the following microbiological methods:
  • Challenge test
  • Microbiological assay for vitamins

Analytical Techniques

  • Gas Chromatography- Flame Ionization Detector (GC-FID)
  • Gas Chromatography Mass Spectrometry (GC-MS)
  • Gas Chromatography, Head Space
  • HPLC-UV
  • HPLC, Mass Spectrometry (MS)
  • Flame Atomic absorption spectroscopy
  • Graphite furnace atomic absorption spectrometry
  • FT-IR
  • Molecular absorption spectroscopy, UV-Visible
  • NMR (400 MHz)

Contact

  •   info@inkemia.com
  •  +34 93 579 34 32
  •  +34 93 570 57 45
  •  C\ Àlvarez de Castro, 63, 08100
    Mollet del Vallès (Barcelona)