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Particle Science & Engineering Delivering expertise in Polymorph, Salt, Co-crystal screening & Crystallization

The PS&E group at Sai Life Sciences offers screening of most preferred/stable solid form (polymorph) and version (salt and co-crystal) for development. This group also develop robust & scalable crystallization processes with in-line PAT monitoring and offers process controls on physical properties like specific solid form, specific/micronized size distribution and flow behaviour.

Delivering expertise in Polymorph, Salt screening & Crystallizations
PAT Enabled Crystalisation

Highlights

  • Located across Manchester, UK and Hyderabad, India
  • Our in-house capabilities and expertise allows rapid selection of most appropriate solid form and version of compounds from preclinical to clinical & commercial stages of development.
  • Sai uses in-depth scientific crystallization concepts & operate within Meta Stable Zone Width (MSZW) boundaries in designing controlled crystallization processes.
  • We apply in situ & online real time monitoring of crystallization processes using PAT tools like FBRM, PVM and Blaze.
  • Particle size reduction technologies (both bottom-up crystallization & top down micronisation).
  • Highly experienced team of scientists with cumulative experience of 50+ years.
  • Infrastructure supporting the entire spectrum to cater from discovery to early phase to CMC to integration of client feedback.

Key offerings

  • Version screening (salt & co-crystals) and recommendation of suitable salt / co-crystal for development.
  • Phase-appropriate solid form / polymorph screening and recommendation of preferred / thermodynamically stable solid form for development.
  • Solubility curves and MSZW determination using Crystal16™
  • Development of controlled, robust & scalable crystallization processes using in-line PAT tools and QbD based study designs.
  • Crystallization process development to meet critical quality attributes for the final product such as desired solid form/polymorph, particle size distribution or bulk properties.
  • Process optimization for manufacturing and scale- up, including structured problem-solving approach to mitigate scale up risks.
Polymorph Monitoring using PVM

Best-in-class infrastructure

Parallel reactors/crystallisers

  • Mettler Toledo EasyMax 402™ controlled lab reactors (100–400 mL)
  • Radleys™ (500 mL, 1 L)
  • Mya-4 parallel crystallizer
  • HELTM Polyblock PB4

PAT tools

  • Mettler Toledo particle track FBRM (G400)
  • Blaze Metrics with Raman
  • Mettler Toledo ReactIR 702L
  • PVM (V19)

Particle size reduction

  • Microniser (M-50), R&D & plant scale (M-200)
  • R&D scale POC (Bead milling)

Solid form & version screening

  • Crystal16™
  • Miniaturised parallel crystalliser

Physical property characterisation

  • PXRD
  • Modulated DSC & TGA
  • DVS
  • Malvern Mastersizer
  • FT-IR, NMR
  • Other orthogonal techniques