Particle Science & Engineering
Particle Science & Engineering (PS&E) at Sai Life Sciences functions as a Subject Matter Expert (SME) in materials science and crystallization process development, with a strategic focus on delivering API solid-state attributes that ensure manufacturability, physical and chemical stability, and optimal product performance.
Our capabilities include the systematic screening, identification, and selection of suitable salt forms, co-crystals, and polymorphic forms of APIs. We develop robust and scalable crystallization processes to consistently produce the phase-pure target solid form with the desired particle size distribution (PSD) and morphology, tailored to downstream processing and formulation requirements.
Process development is driven by a mechanistic, data-centric approach, integrating:
- Process Analytical Technology (PAT) for real-time process understanding
- Automated crystallization platforms (e.g., Crystal16, EasyMax) for efficient screening and optimization
- Advanced solid-state characterization tools (e.g., PXRD, DSC, TGA, DVS, Malvern Mastersizer 3000, etc) for comprehensive phase and property analysis
Through this integrated framework, we establish scalable, reproducible, and scientifically well-understood crystallization processes, aligned with Quality by Design (QbD) principles and global regulatory expectations. Close collaboration with Process R&D, Analytical R&D, Engineering, and Formulation Development teams ensures that solid-form selection and process understanding are effectively translated into robust downstream
Our Capabilities
Version & Solid-Form Screening
Salt, co-crystal, polymorph, and amorphous screening to identify development-appropriate solid forms.
Crystallization Process Development
De novo crystallization design with control over polymorph, PSD, and critical quality attributes.
Solubility & Biorelevant Studies
Solubility profiling across physiological pH and biorelevant media to guide formulation strategy.
Particle Size Engineering
PSD control through controlled crystallization and micronization (wet milling and jet milling).
Solid-State Characterization
Phase identification, crystallinity assessment, polymorphic purity, and amorphous content determination.
Stability & Form Robustness
Hygroscopicity evaluation, stress testing, and ICH-compliant stability studies.
Crystallography
PXRD and Single Crystal X-ray Diffraction (SCXRD) for definitive structural and polymorph characterization.
Our Capabilities
Version & Solid-Form Screening
Salt, co-crystal, polymorph, and amorphous screening to identify development-appropriate solid forms.
Crystallization Process Development
De novo crystallization design with control over polymorph, PSD, and critical quality attributes.
Solubility & Biorelevant Studies
Solubility profiling across physiological pH and biorelevant media to guide formulation strategy.
Particle Size Engineering
PSD control through controlled crystallization and micronization (wet milling and jet milling).
Solid-State Characterization
Phase identification, crystallinity assessment, polymorphic purity, and amorphous content determination.
Stability & Form Robustness
Hygroscopicity evaluation, stress testing, and ICH-compliant stability studies.
Crystallography
PXRD and Single Crystal X-ray Diffraction (SCXRD) for definitive structural and polymorph characterization.
Facilities & Technical Infrastructure
We leverage a suite of advanced continuous‑processing technologies that empower our partners with faster development, smarter manufacturing, and consistently higher‑quality outcomes:
Crystallization & Process Development
- Crystal16 for throughput solubility studies
- EasyMax™ automated reactors for crystallization development
- Integrated PAT tools:
- FBRM (Focused Beam Reflectance Measurement)
- PVM (Particle Vision & Measurement)
- ReactIR
- Blaze
Particle Size Engineering
- IKA Magic Lab for wet milling
- Jet milling systems for micronization
Solid-State & Analytical Characterization
- PXRD
- DSC, TGA, DVS
- FT-IR and NMR
- HPLC, GC, KF
- Particle Size Analyzer and Powder Flow Tester
Capability to handle potent compounds up to OEB 5 containment level
Frequently Asked Questions
Yes, Sai Life Sciences offers comprehensive solid-form screening services, including evaluation of salts, co-crystals, polymorphs, and amorphous forms.
Screening studies are conducted under a wide range of solvent systems, temperatures, and crystallization conditions to ensure broad form coverage. The resulting solid forms are thoroughly characterized using advanced analytical techniques such as PXRD, DSC, TGA, FT-IR, NMR, DVS, FT-IR, HPLC, GC, KF etc to establish phase identity, crystallinity, thermal behaviour, and solid-state stability. Based on these studies, thermodynamically stable form is identified and prioritized for further development. In parallel, metastable forms are systematically evaluated from a risk mitigation, control strategy, and intellectual property (IP) perspective, enabling informed decision-making for downstream development.
Yes, Sai Life Sciences has expertise in preparation of amorphous APIs and Amorphous Solid Dispersions (ASDs) to address solubility- and bioavailability-related challenges.
Amorphous forms of APIs are generated using enabling technologies such as spray drying, lyophilization, and solvent evaporation techniques, depending on the physicochemical properties of the molecule.
For ASDs, we design and optimize formulations using pharmaceutically acceptable polymers (e.g., HPMC, HPMCAS, PVP-based systems) to enhance apparent solubility, improve dissolution performance, and inhibit recrystallization.
Comprehensive characterization is performed using techniques such as mDSC, XRPD, etc and spectroscopic methods to confirm the amorphous nature, glass transition temperature (Tg), and physical stability. Stability is further evaluated under ICH-recommended storage conditions to assess the propensity for recrystallization and ensure long-term product performance.
Yes, Sai Life Sciences conducts comprehensive solubility profiling in both aqueous and biorelevant media to support formulation development and enable prediction of in vivo performance.
Solubility is systematically evaluated across physiologically relevant pH conditions (e.g., pH 1.2, 4.5, and 6.8) to understand pH-dependent solubility behaviour. In addition, studies are performed in biorelevant media, such as FaSSIF (Fasted State Simulated Intestinal Fluid) and FeSSIF (Fed State Simulated Intestinal Fluid), to better mimic gastrointestinal conditions.
These studies provide critical insights into solubility, dissolution potential, and formulation strategy, supporting informed decision-making for enhancing bioavailability and in vivo performance prediction.
Yes, Sai Life Sciences offers comprehensive crystallization process development to consistently achieve the target polymorphic form and particle size distribution (PSD) with scalability in mind.
Our approach includes systematic solvent selection, solubility assessment, crystallization method, and metastable zone width (MSZW) determination, followed by process optimization to define robust crystallization conditions. Development is carried out using EasyMax™ reactors integrated with Process Analytical Technology (PAT) tools such as FBRM, PVM, ReactIR, and Blaze, enabling real-time monitoring of supersaturation, nucleation, crystal growth kinetics, and phase behaviour.
We also evaluate and optimize seeding strategies (seed loading, temperature, and PSD) to ensure process reproducibility, control over crystal attributes, and scalability. This data-driven and mechanistic approach enables the design of robust, transferable crystallization processes aligned with downstream manufacturing requirements.
Particle size and morphology are controlled through a combination of crystallization process design and downstream particle engineering techniques.
During crystallization, key process parameters such as supersaturation profile, cooling rate, anti-solvent addition rate, agitation intensity, and seeding strategy (seed loading, temperature, and PSD) are systematically optimized to achieve the desired particle size distribution (PSD) and crystal habit/morphology.
Real-time monitoring using Process Analytical Technology (PAT) tools (e.g., FBRM, PVM probes) enables precise control over nucleation and crystal growth, ensuring reproducibility and robustness of the process.
Where required, targeted particle size reduction is achieved through micronization techniques, including wet milling and jet milling, to further refine PSD while maintaining solid-state form integrity.
This integrated, mechanistic approach ensures consistent control of particle attributes aligned with downstream processing, formulation performance, and manufacturability requirements.
Yes, Sai Life Sciences provides comprehensive crystallography and solid-state characterization services to support solid-form identification and structural elucidation.
Powder X-ray Diffraction (PXRD) is routinely used for polymorph identification, crystallinity assessment, and phase purity evaluation, enabling rapid and reliable differentiation of solid forms.
Where definitive structural information is required, Single Crystal X-ray Diffraction (SCXRD) is employed to provide unambiguous determination of molecular and crystal structure, including polymorph differentiation and crystal packing arrangements.