Birdotech

Professional

Efficient

Integrated

Solid-state Research Platform

We provide comprehensive solid-state research services for small molecule drugs/APIs. With years of solid-state research experiences on drugs development, we offer discovery of new solid-state forms services including polymorph screen, salt screen and co-crystal screen, crystallization process development support and polymorphs evaluation such as solubility tests and stability studies, even for difficult products like partially crystalline materials and amorphous materials. An integrated approach to solid-state development will be provided accordingly.

What can we offer (including but not limited to):

Polymorph/salt/co-crystal screening,
evaluation and selection

Chiral resolution by crystallization
to obtain desired compound

Solid-state characterization service
such as XRPD, TGA, DSC

Crystallization process development
and optimization (such as impurity
rejection, particle size control,
residual solvent rejection)

Single crystal growth and structure
determination for targeted molecular

Comprehensive form screen to
obtain non-infringing novel form for
FTF ANDA

Polymorphism Investigation & Form Selection

Polymorph/salt/co-crystal screen

Identification of anhydrates, hydrates and solvates

Evaluation of polymorphic transformations

Physicochemical properties investigation, such as solubility test, stability studies, etc.

Identification of thermodynamic most stable form

Crystallization Process Development and Optimization

Evaluation of different crystallization techniques (cooling, seeding, addition
of anti-solvent, pH shift, etc.)

Variation of solvent systems studies (solubility investigate, solvent class,
metastable zone width, etc.)

Process development in terms of crystal design (size, shape, etc.)

Systematic variation of relevant process parameters optimization (cooling
profile, stirring profile, seeding process, spiking with impurities, etc.)

Optimization of process and bulk properties (space volume yield,
morphology, filterability, etc.)

Full characterization for final product (HPLC analysis, X-ray powder
diffraction, particle size distribution, microscopy, etc.)