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PolyCrystalLine CDMO

PolyCrystalLine CDMO is listed as a small business research supplier in the Scientist.com network, with 6 sites in 1 country.

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Sites 6
Countries 1

Services

What this research supplier says it provides, as listed in the Scientist.com network.

Type of company: Small business

Chemical and Compound Analysis

  • API Physical Characteristics Characterize physical and chemical properties of new drug molecules to develop safe, effective, and stable dosage forms.
  • Chemical Stability Measure the stability of small molecules in solution.
  • Dissolution Profiling Measure release of API from formulation (tablet or capsules) under GMP guidelines.
  • Solubility Studies Analyze substances for kinetics of solubility using nephelometry and UV-Vis spectrometry.
  • Spray Drying Convert a liquid into a powder by rapidly drying the mixture and removing the moisture component.

Chemistry, Manufacturing and Controls (CMC)

  • Advanced intermediates Sourcing advanced intermediates
  • Analytical Development and Validation Request services related to Analytical Development and Validation
  • API and Drug Product Stability Testing API and Drug Product Stability Testing.
  • API and drug product storage and release API and drug product storage and release
  • API manufacturing process development, tech transfer and validation API manufacturing process development, tech transfer and validation
  • API/ Excipients Compatibility Studies Delineate real and possible interactions between potential formulation excipients and the API as an important risk reduction exercise early in formulation development.
Show all 18 in Chemistry, Manufacturing and Controls (CMC) 12 more
  • API/DP specific test methods API/DP specific test methods (e.g., stability indicating HPLC assay and purity)
  • Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services
  • Compendial test methods Run Compendial test methods (e.g., KF)
  • Crystallization studies Crystallization studies
  • Drug Product Stability Use accelerated stress conditions to determine degradation pathways and identify manufacturing issues.
  • Drug Substance and Drug Product Characterization and Manufacturing Drug Substance and Drug Product Characterization and Manufacturing.
  • GMP Synthesis Synthesize APIs including small molecules, formulations and protein-based drugs under GMP compliance.
  • ICH-compliant stability testing Perform ICH-compliant stability testing
  • Milling, grinding, spray-drying Milling, grinding, spray-drying
  • Polymorph Screening Screen for unwanted API forms resulting from the drug formulation process.
  • Salt Form Selection Use high-throughput automated arrays to combine APIs with multiple salts and ions to optimize formulation.
  • Thermal Analysis Characterize compounds based on calorimetry and thermodynamic data.

Testing Services

  • Package Compatibility Tests Ensure that the consumer product is not adversely affected by the package components and vice versa.

Source: Scientist.com supplier network

Where it operates

Sites by country, with the cities in each.

  • Italy Medicina, Mesagne 6 sites

Source: Scientist.com supplier network (site locations)

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Sources: Scientist.com supplier network.

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