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.

    
 
 
       Posted on Google  
   
   Neil Sim 
 
 
 
 Trustindex verifies that the original source of the review is Google. At HFR, we have collaborated with Solitek across numerous projects for a number of years. Across all projects that we have collaborated on, I have felt that Solitek really work to fully understand the project from the outset. Victor, Steve and all of the team provide expert knowledge across the solid state landscape and combine a methodical approach with scientific rigour. Their communication and reporting is thorough and clearly presented, providing further value when working on more challenging and complex landscapes.
  
 
      Posted on Google  
   
   Anthony Debono 
 
 
 
 Trustindex verifies that the original source of the review is Google. I have collaborated directly with Solitek on a number of projects. I highly recommend the team. They combine deep technical expertise and experimental know-how, with an efficient and collaborative customer service. Thanks to their decades of experience in the field they are able to give solid advice on development approaches and are proactive and transparent during project execution.
  
 
      Posted on Google  
   
   Josep Castells 
 
 
 
 Trustindex verifies that the original source of the review is Google. La experiencia con Solitek durante el desarrollo de una molécula activa farmacéuticamente fue muy positiva por su gran profesionalidad y la capacidad de superar los retoques técnicos.
  
 
      Posted on Google  
   
   Adria Espinas Torres 
 
 
 
 Trustindex verifies that the original source of the review is Google. Great experience working with Solitek from Farmhispania Group on solid-state projects. We collaborated in the development of robust and scalable API crystallization processes and solid form selection and characterization, and they always bring clear, practical solutions. Working with Steve, Víctor, and the rest of the team has been very smooth, with close and easy communication throughout. They are agile, adapt well to project needs, and are strongly results-oriented. Strongly recommended!
  
 
      Posted on Google  
   
   David 
 
 
 
 Trustindex verifies that the original source of the review is Google. AKL Therapeutics had approached Solitek regarding an unusual and difficult  issue associated with a liquid eutectic formulation.
Solitek devised a clear and systematic plan of investigations to solve the outstanding problems and were well equipped to conduct the necessary specialist studies in this area. The staff have very good practical knowledge and experience in the area of pharmaceutical formulation development.
The investigations Solitek conducted proved to be fully enlightening as to and understanding of key issues involved in the development of a suitable formulation for the concerned molecules.
The standard of reporting was excellent with regular scheduled updates that were well communicated by the Solitek team.
We would certainly recommend Solitek as a competent and capable partner in the area of pharmaceutical formulation development.
John McCrerie for AKL Therapeutics
  
 
      Posted on Google  
   
   Ernesto Durán López 
 
 
 
 Trustindex verifies that the original source of the review is Google. Over the past few years, we have carried out several collaborations with Solitek to address different aspects related to the solid‑state development of pharmaceutical active ingredients. These projects have included salt‑screening studies to modulate API solubility, the exploration of new polymorphic forms and co‑crystals to help overcome IP barriers, and the optimization of process parameters to enhance the robustness of crystallizations at industrial scale.

Throughout all these collaborations, the Solitek team has consistently demonstrated strong technical expertise, provided high‑value scientific input, met every agreed timeline, and delivered reports of outstanding quality. Without a doubt, having them by our side when complex challenges arise makes a real difference.
  
 
      Posted on Google  
   
   DBS Chen 
 
 
 
 Trustindex verifies that the original source of the review is Google. With over 20 yrs of outsourcing experience, I have to say Solitek is efficient, comprehensive, and budget-friendly. Their expertise gives me peace of mind when they handle my projects.
  
 
      Posted on Google  
   
   Marta Monjo 
 
 
 
 Trustindex verifies that the original source of the review is Google. Solitek nos ha ayudado muchísimo en la optimización y el escalado de nuestro proceso. Han demostrado un gran conocimiento técnico y una excelente capacidad para encontrar soluciones prácticas a los retos que han ido surgiendo durante el proyecto.

Los estudios de familiarización realizados posteriormente en planta kilo-lab fueron todo un éxito y nos aportaron información muy útil para seguir avanzando. Además, durante todo el proceso de industrialización han seguido brindándonos apoyo y asesoramiento ante cualquier consulta o necesidad que ha surgido, demostrando un gran compromiso con el éxito del proyecto.

Ha sido un placer trabajar con un equipo tan profesional, cercano y comprometido. Muchas gracias!
  
 
      Posted on Google  
   
   I Maikel 
 
 
 
 Trustindex verifies that the original source of the review is Google. Nuestras colaboraciones con Solitek han sido muy satisfactorias. Su profundo conocimiento del estado sólido, y de los procesos de optimización y escalado han rendido procesos sólidos, fiables, bien documentados y fáciles de transferir. Un placer trabajar con ellos.
  
 
      Posted on Google  
   
   Jacques Alain Bauer 
 
 
 
 Trustindex verifies that the original source of the review is Google. The experience with Solitek Pharma projects were perfect, with real-time communication, very flexible collaboration and excellent reporting.

Working Together and Strategic Partners

The Value of Experience

Our 3-Step Work Process

Seamless integration as part of your own laboratory

STEP 01

Technical Assessment and Scope Definition

We analyze your existing API data, identify crystallization risks, and define key objectives (polymorph, PSD, purity, yield)

STEP 02

Testing Execution and Process Optimization

We execute the work plan at our facilities in the Barcelona Science Park, using advanced characterization and screening tools to reduce risk and optimize every phase of the process.

STEP 03

Clear, Data-Driven Action Plan

We deliver a detailed, actionable technical report, ready for use in regulatory audits or direct transfer to your CDMO.

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.

From there, you can decide whether we’re the right professional partner for your needs.