Understanding the Solid-state / Particle Design space is critical for the successful development of many Active Pharmaceutical Ingredients (APIs). Our solid form team, integrated within our R&D department, offers comprehensive support for customer project development. This approach ensures that solid-state expertise is a fundamental part of each stage of process development, delivering highly valuable outcomes.
Our solid-state
Studies go beyond exploring the polymorphic landscape of an API or HPAPI and its impact on bioavailability. They are an essential component of process development, which combine scientific rigor with a manufacturing-driven approach, such as:
Select the Optimal
Crystalline Candidate
We carefully evaluate crystal form and morphology to ensure the most suitable candidate for production and performance.
Develop Scalable
Crystallisation Processes
Our robust processes are designed for smooth scalability from lab to production, ensuring suitable filtration properties and meeting the required quality attributes of the final product.
Define Robust Seeding Parameters
Through metastable zone width determination, we establish precise seeding points for controlled crystallization.
Conduct Comprehensive
Screening Studies
We perform in-depth polymorph, salt and cocrystal screening, including characterisation and relative stability assessments.
Optimize Chiral Resolution
Our team enhances processability through advanced approaches for diastereomeric salt formation and entrainment.
Engineer Scalable Processes
Solubility studies and phase diagram investigations enable us to develop processes ready for industrial-scale implementation.
Enhance Filtration and Drying
By assessing specific cake resistance and compressibility, we optimize filtration and drying performance.
Refine Particle Size
We leverage advanced dry and wet milling and micronisation technologies for precise particle size control.
Control Particle Size Distribution
We meticulously manage particle size to adhere to strict customer specifications.
Safeguard Intellectual Property (IP)
Our expertise underpins IP development to protect innovations.
Our Advanced equipment
For solid-state characterization, enabling in-depth analysis of the physical and thermodynamic properties of your compounds.
With state-of-the-art technologies like XRPD, TGA-DSC, microscopy and laser diffraction for particle size analysis, we ensure an in-depth evaluation..
Team within R&D
By integrating our solid form team at the beginning of your project, Minakem ensures that crystallization expertise is designed into your manufacturing process.
This collaborative approach streamlines process optimization and troubleshooting, delivering reliable, high-quality solutions tailored to our customers’ requirements.
Partnering with Minakem means benefiting from an innovative, integrated approach to API and HPAPI development, where excellence in crystallization drives remarkable results.