Tailored Expertise from Molecule to Market Readiness
We offer the right flexibility to engage at any stage. Whether optimizing complex APIs or scaling manufacturing, our approach reduces risk in development while ensuring speed to market and regulatory confidence.
Our Approach
Feasibility Studies & Preformulation
- Tailored API evaluation to meet unit dose and product goals.
- Identification of API properties (solubility, stability, compatibility).
- Prototype testing with bench scale formulations.
- 4 week accelerated stability studies to guide recommendations.
Analytical Characterisation
- Optical Microscopy: Monitors API crystal forms and formulation changes.
- Freeze Drying Microscopy: Identifies collapse and glass transition points.
- Particle Size Analysis: Ensures suspension stability for insoluble APIs.
- Dynamic Vapor Sorption: Evaluates moisture interaction and stability.
- Polymorph Analysis: Uses X-ray Powder Diffraction (XRPD) to monitor solid state behaviour.
- Chemical Testing: Ensures integrity with High Performance Liquid Chromatography (HPLC), Ultraviolet (UV) and Fourier Transform Infrared Spectroscopy (FTIR) methods.
Prototype Refinement & Optimization
- Application of taste masking toolkit including flavours, sweeteners, pH adjustment or complexation if required.
- Use of Design of Experiments to optimise formulation to Quantitative Target Product Profile.
- QbD Scale up to establish critical process parameters and in-process controls.
Full-Scale Manufacturing
- Fully integrated line with secondary packaging and serialisation to reduce lead time.
- Automated Industrial Personal Computers (IPCs) and Electronic Batch Records for quality assurance, compliance and optimal yields.
- Current capacity of over 200 million tablets on validated line.
Regulatory Support & Lifecycle Management
- Capability to manage pilot & pivotal BE studies at a network of EU and USFDA approved Contract Research Organizations (CROs).
- Expertise in compiling and filing full eCTD to USFDA/ EU and other key markets.
- Support in key variations for batch size & shelf life increases and continuous improvements.
Partner with Us
Tenshi Kaizen has the platform technology and taste masking expertise to bring your Target Product Profile ODT from feasibility to market using QbD principles. Tenshi Kaizen currently operates a state-of-the-art facility in Bengaluru with a capacity of 300 million ODTs which is set to scale up to 500 million ODTs.
Our fully automated, integrated line with serialisation and electronic batch records simplifies your supply chain with the highest quality and regulatory compliance standards. We always invest in capacity well in advance of requirements so you can trust us to be your turnkey CDMO partner for your next patient-centric medicine.