Next-Generation
Pharmaceutical
Manufacturing
Empowering pharmaceutical manufacturers to overcome complex production challenges and bring better medicines to patients faster.
We shape the future of pharmaceutical manufacturing by combining material expertise and advanced production technology with deep process understanding across continuous manufacturing, flow chemistry, process control and process analytical technology (PAT), pharmaceutical 3D-printing, powder technology and particle engineering.
Our interdisciplinary teams, state-of-the-art equipment and our unique pilot plant help you adopt new manufacturing technologies efficiently based on the latest-state-of-the-art.
What we Do
Advanced Manufacturing Science
We build deep expertise in advanced manufacturing science, from continuous solid dosage form production to flow chemistry, nano-pharmaceuticals production and biologics processing
Personalized Manufacturing
We offer deep know-how in personalized manufacturing, from 2D- and 3D-printing for individualized dosage forms to women’s health solutions via hot-melt extrusion processes.
Quality and Infrastructure
We use a reliable, validated infrastructure featuring rigorous quality management standards (ISO 9001:2015 and ISO 14001:2015 certifications) and regular equipment maintenance and calibration to meet industry standards.
Safe Handling of Potent Compounds
Scale-Up & Technology Transfer
Digital Twins
We supply company partners with digital twins, in close collaboration with our simulation experts at RCPE.
Areas of Application
Our capabilities span the technologies and analytical approaches driving advanced pharmaceutical manufacturing, from continuous processing and nano-pharmaceuticals to additive manufacturing and particle engineering.
Continuous manufacturing of oral dosage forms
We are recognized experts in continuous manufacturing, including wet granulation, dry granulation and direct compaction for oral dosage forms including capsules, tablets and minitablets, which can be tested in our state-of-the-art pilot plant.
Continuous manufacturing of nano-pharmaceuticals
We develop and optimize nano-pharmaceutical formulations and the associated processes using advanced techniques, such as micro-reactors, impingement jet mixing, microfluidic mixers and high-pressure homogenization, to precisely tailor particle size and distribution. Moreover, we develop advanced process analytical and process control tools for lipid and polymeric nanoparticles as well as nanocrystals.
Process Analytical Technology (PAT) and data-driven decision making
We go beyond simply collecting data – we develop novel sensor technology (UHR-OCT, soft sensors, etc.) and deliver actionable insights that enable real-time process monitoring and control. By transforming raw data into regulatory-ready information, we facilitate robust CMC documentation and support real-time release testing (RTRT), aligning with global regulatory standards and reducing reliance on traditional batch release methods.
Hot-melt extrusion (HME) for advanced formulations
RCPE is a leader in designing and scaling hot-melt extrusion (HME) as a core of our next-generation manufacturing toolbox to create stable amorphous solid dispersions (ASDs) or long-acting dosage forms. We leverage our HME and co-extrusion experience to develop intermediates (e.g., injectable micro-pellets, filaments, powders) and products (implants, vaginal rings) to combine HME with direct compaction in integrated continuous manufacturing lines.
Pharmaceutical 3D-printing & additive manufacturing
We process monographed, regulatory approved materials so they become suitable for pharmaceutical 3D-printing, tailoring process parameters to ensure pharmaceutical grade 3D-printed dosage forms – unlike others who may rely on non-pharma-grade polymers. RCPE has developed specialized methods to process highly brittle and highly elastic materials, which are traditionally difficult to shape into reliable and robust dosage forms.
Spray drying
Spray drying (SD) is a key technology at RCPE for producing numerous advanced products, ranging from biopharmaceuticals to amorphous solid dispersions of poorly soluble drugs. Having a repertoire of SD scales available, RCPE is an expert in the design, scale-up and optimization of SD, from lab and early development to GMP compliant commercial manufacturing.
OCT and other advanced analytical techniques
Using optical coherence tomography (OCT) and other cutting-edge analytical technologies, we select the most suitable methods for your specific manufacturing challenges, such as coating and compaction. This ensures precise, non-destructive insight into product and process performance and enables reliable data-based decision-making across a wide range of pharmaceutical manufacturing scenarios.
Miniaturized processing and flow synthesis
We generate maximum information from even the smallest API quantities (down to sub-gram scale), enabling efficient process and formulation development when material is scarce. This supports the creation of personalized medicines as well as early clinical development, where limited API supply must be used as effectively as possible. Moreover, we pioneer synthetic routes in flow based on a host of challenging chemistries together with RCPE’s CC FLOW team.
Powder Technology & Particle Engineering
Our expertise in powder technology and particle engineering spans advanced material characterization and understanding of powder behavior across key unit operations. We combine advanced powder profiling and material characterization with innovative feeding solutions for complex, low-dose powders. Using diverse particle engineering techniques, we design particles with tailored size, morphology, and crystallinity, to enable high-performance formulations.
Why partner with RCPE to solve your pharmaceutical manufacturing challenges?
Interdisciplinary teams with real-world experience
Equipment from all major manufacturers
Documentation supporting submission
Non-disruptive testing environment
End-to-end support
Ready to advance your pharmaceutical manufacturing processes?
Contact us to explore how RCPE’s next-generation manufacturing solutions can help you solve your toughest production challenges – efficiently, safely, and in full compliance.
Contact
Dr. Martin Spörk
Núria Canal Paulí, MSc