STEP 01
Technical Assessment and Scope Definition
We analyze your existing API data, identify crystallization risks, and define key objectives (polymorph, PSD, purity, yield)
Crystallization Process Development Services for Pharma & Biotech: From Lab to Plant-Ready Scale-Up
Robust, scalable, and plant-ready crystallization processes for small-molecule APIs
De-risk your API manufacturing with robust, reproducible, and scalable crystallization processes designed for seamless technology transfer and long-term IP protection.
Total Control
Total control over polymorphism, particle size and morphology
Seamless Transition
Seamless transition from preclinical phase to industrial scale (CDMO readiness).
+ 40 Years of Solid State
Over 40 years of cumulative experience in solid state.
+ 1000 Projects Executed
More than one thousand challenging projects executed and succesfully delivered.
The High Cost of Uncontrolled Crystallization
Are Operational Setbacks Risking Your Timeline?
- Crystallization is a crucial step that defines the properties of the API, its processability in the plant and its safety-regulatory profiles.
- Batch to batch variability: unpredictable behavior in the crystal can lead to out-of-specs batches.
- Quality deviations: a temperature excursion or an excess of residual solvent can alter the crystal and damage the API performance.
- Unexpected changes of polymorph: an undesired or metastable polymorph during scale up and production can ruin years of investment.
- Filtration and poor drying: unoptimized crystal morphology can block filters and instruments, slowing down processes very significantly.
- Tech transfer failures: crystallization processes developed in the lab do not behave in the same way in the plant, leading to high reprocessing costs and stresses with your CDMO.
Solitek Solutions and Methods for Crystallization Processes
Scalable & Robust Crystallization Process Design: Built for Real-World Manufacturing
We develop crystallization processes focused on stability, reproducibility and industrial control from the start:
1) Determination of metastable zones and solubility curves
Accurate determination of solubility curves and supersaturation limits to define safe operational windows and to avoid uncontrolled nucleation.
2) Seeding and crystal growth strategies
Optimization of type, loading and seeding regime to ensure polymorphic control and a consistent particle size distribution.
3) Control of crystalline habit and morphology
Modification and control of the crystalline form to drastically improve filtration rates, cake washing and flow properties.
4) Tech transfer and plant-ready procedures
Generation of robust data packages (PAR and NOR) to guarantee crystallization scale up without surprises at your CDMO's facilities.
Reduce risks and optimize processes with our crystallization development services.
Accelerate Clinical Progression & Secure Your API Intellectual Property
- Risk Control and Regulatory Compliance: We share our expertise to reduce process risk and advise you on meeting regulatory requirements.
- Operational Efficiency: We reduce filtration and drying cycle times in the plant, maximizing yield per batch.
- Intellectual Property Protection: Identification of novel crystalline forms and patentable processes that extend your API's lifecycle.
- Effective Communication with CDMOs: Clear protocols that prevent technical disputes, unforeseen costs, and delays in commercial manufacturing.
- Optimized R&D Budget: Our computational prediction tools and microscale methodology allow us to drastically reduce the amount of API needed for studies.
- Internal Alignment: We act as an impartial internal catalyst, delivering results and data with practical judgment, enabling your R&D and CMC teams to make aligned, fast decisions.
Tailored Crystallization Services for the Global Pharmaceutical Industry
We tailor our scientific approach to the specific needs of each player in the sector.
Emerging Biotech & Virtual Pharma:
Empresas biotecnológicas que necesitan maximizar el valor de los principios activos farmacéuticos (API) antes de otorgar licencias o avanzar a la fase clínica para realizar pruebas en humanos.
Mid-to-Large Pharma Companies:
Companies looking to resolve complex crystallization or polymorphism bottlenecks that their internal teams don’t have the resources to address.
Generic Pharmaceutical Companies:
Companies that require alternative, non-infringing, low-cost crystallization processes to secure freedom to operate.
Reviews from Clients Who Have Worked with Us
"The team at Solitek is world-class. Experts in their field and with a customer-focused attitude, they have supported us on multiple solid state projects over the years, consistently delivering both in terms of technical execution and clean project management and reporting”.
Anthony Debono
Head of R&D API – Medichem, SA
"Solitek provided a highly professional and efficient service, supporting the scale-up process with clear communication, technical expertise, and reliable results".
Marta Monjo
Full Professor at Universitat de Les Illes Balears
“Trabajar con Solitek ha sido un placer. El reto técnico al que se enfrentaban era muy complejo y lo resolvieron con optimismo, eficiencia y rapidez. Colaborar con ellos resultó sencillo y ágil. Su conocimiento técnico y su excelente actitud para afrontar y superar desafíos los convierten en un aliado clave para nuestros proyectos en estado sólido y polimorfismo.”
R&D Director
CDMO & Generics Company
‘Efficient, comprehensive, and budget-friendly, Solitek delivered results that exceeded expectations by identifying polymorphs overlooked by another lab. Their expertise gives me peace of mind when outsourcing my projects.’
Wen Chen
Head of CMC at Eccogene, Inc.
About Solitek Pharma
Specialists in Crystallization Process Development
Solitek Pharma was founded to reduce risk and prevent costly failures in small molecule drug development, drawing on over 50 years of accumulated experience in the pharmaceutical industry, including more than 40 years focused specifically on solid-state science.
Our expertise was built at internationally recognized pharmaceutical companies such as GSK, Johnson Matthey, and Almac, Spanish companies such as Esteve and Medichem, and specialized solid-state teams such as Pharmorphix and Enantia.
We have participated in more than 1,000 drug development programs, giving us the practical perspective needed to approach each project with a clear sense of what truly needs to be accomplished and decided at every stage.
Our current company, Solitek Pharma, was founded in 2021 and is based at the Barcelona Science Park (Parc Científic de Barcelona), a hub for operations and specialized talent in our sector.
We are an agile team of experts who work closely with our clients, integrating as an extension of their development teams. We focus on what’s needed here and now, helping projects advance with lower risk and greater value for future partners.
Working Together and Strategic Partners
The Value of Experience
Our 3-Step Work Process
Seamless integration as part of your own laboratory
Frequently Asked Questions About Crystallization Development
1) What amount of API is required for a crystallization process development study?
Traditional screening approaches can consume significant quantities of API, which is a real constraint when material is expensive or supply is limited, as is often the case with biotech assets pre-clinical or pre-licensing.
We use proprietary computational prediction tools alongside microscale experimental methodology to cut the API requirement drastically without sacrificing the reliability of the screening data.
2) How do you ensure the crystallization process is scalable to commercial manufacturing?
We design processes from the very outset with plant-scale constraints in mind (cooling rates, agitation power, mass transfer, and reactor design) avoiding lab-scale conditions that can’t be replicated at large scale.
3) Can you help us if our crystallization process generates an undesired polymorph during scale-up?
Yes, problem-solving complex issues like this is one of our specialties. We analyze the polymorphic landscape, identify the triggers behind secondary nucleation or phase conversion, and redefine the operating options accordingly.
Reduce Risk and Protect Your Timeline with API Scale-Up
Don’t let a deficient crystallization process delay your clinical trials or compromise the value of your molecule.
Contact us for an initial meeting and speak directly with our team of crystallization and solid-state experts.
From there, you can decide whether we’re the right professional partner for your needs.
