Process Development

Process Development
Product Description

We can optimise synthesis and crystallization processes, ranging from synthetic route scouting to process scale-up allowing for batches of grams to kilograms of small-scale production, while ensuring flexible and robust procedure that can easily be transferred to pilot-scale, and finally to high volume industrial production of API that exhibit consistent, and optimised, physical and bulk properties.

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PolyCrystalLine S.p.A

  • IT
  • 2015
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Contract Research Organisation
Custom Manufacturing/Custom Synthesis
View company profile

PolyCrystalLine S.p.A

  • IT
  • 2015
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
CMO/CDMO
Contract Service
Primary activities
API Producer
Contract Research Organisation
Custom Manufacturing/Custom Synthesis
View company profile

More Products from PolyCrystalLine S.p.A (17)

  • Salts Screening

    Product Salts Screening

    PolyCrystalLine offers a wide range of solid form screening which includes salts screening. It is one of the primary solid-state approaches used to modify the physical properties of apis, a major limitation within this approach is that the api must possess a suitable (basic or acidic) ionisable site. Conta...
  • Solvates/Hydrates Identification

    Product Solvates/Hydrates Identification

    PolyCrystalLine offers a wide range of solid form screening which includes solvates/hydrates identification. It is an amorphous and crystalline forms, a solid drug may be anhydrous or a solvate/hydrate. When a solid form contains a solvent, it is known as a solvate. Contact us for more information.
  • Stability Studies

    Product Stability Studies

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes Stability studies. Its thermodynamic relationships between polymorphic forms is crucial and must be established carefully, because as drug crystallises from different conditions the kinetically favoured metastable polymorph appea...
  • Structural Characterization

    Product Structural Characterization

    PolyCrystalLine offers a wide range of analytical services which includes structural characterization. Its an characteristics of the unit cell can be used to predict the morphology and physical properties of a drug, provides phase identification of a crystalline material and information on unit cell dimens...
  • Thermal Analysis

    Product Thermal Analysis

    PolyCrystalLine offers a wide range of analytical services which includes thermal analysis. Its an indicator of conformational stability, reaction-rates and composition of the sample. They are also useful for determining sample purity and water, carbonate and organic contents and for studying decomposition...
  • cGMP Manufacturing

    Product cGMP Manufacturing

    Our new small molecule API custom manufacturing capabilities integrated with our R&D facility will allow PolyCrystalLine CDMO to bring your project from early phase development to scale-up and commercial manufacture ensuring the right solid forms. We have been doing this for many years. PolyCrystalLine CDM...
  • Api-Excipient Compatibility Studies

    Product Api-Excipient Compatibility Studies

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes API-excipient compatibility studies. It contains excipients which can affect the chemical, physical and therapeutical properties, product stability and may even cause a change in the API polymorphic form. Its interactions is a cr...
  • Cgmp Quality Control

    Product Cgmp Quality Control

    PolyCrystalLine offers a wide range of analytical services which includes cgmp quality control. Its provide a full complement of state-of-the-art gmp analytical testing resources and expertise to support cgmp quality control testing for raw materials, active pharmaceutical ingredients (api) and intermediat...
  • Co-Crystals Screening

    Product Co-Crystals Screening

    PolyCrystalLine offers a wide range of solid form screening which includes co-crystals screening. It is an molecular crystals in which at least one of the compounds is an active pharmaceutical ingredient (api). Salts are considered different from co-crystals provided that its crystals formed by ionic multi...
  • custom synthesis

    Product custom synthesis

    Api and impurities
  • Dissolution Testing

    Product Dissolution Testing

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes Dissolution testing. It is a Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilisation of the drug under physiological...
  • In Vitro Bioequivalence Studies

    Product In Vitro Bioequivalence Studies

    PolyCrystalLine offers a wide range of Pre-formulation studies which includes In vitro bioequivalence studies. It is considered as a surrogate for clinical evaluation of the therapeutic equivalence of drug products based on the fundamental bioequivalence assumption that when two drug products are equivalen...
show all 17 other products

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