CMAC National Facility - Drug Product
From raw material to finished form
Drug product and secondary manufacturing cover every process required to transform raw materials or intermediates into high-value finished products. Getting those processes right and getting them right early, is critical to development timelines, regulatory success and commercial viability.
At CMAC, we combine cutting-edge research, advanced process technologies and a uniquely integrated facility to deliver tailored solutions to your specific formulation and manufacturing challenges.
Make faster, evidence-based formulation decisions using predictive models — not trial and error
Characterise raw materials and blends at gram scale before committing to larger studies
Simulate scale-up risk from lab to pilot to industrial with validated tools and equipment
Address specific challenges like poor solubility, cohesive powders, amorphous materials, through focused bespoke studies
What sets us apart
Over 30 predictive modelling assets — major insight from under 25g of material
In early pharmaceutical development, material is scarce and the cost of wrong decisions is high. Our teams have built over 30 predictive modelling tools — incorporating machine learning and AI, that address specific drug product challenges with less than 25g of sample.
From excipient selection and process parameter optimisation through to dissolution modelling and accelerated stability prediction, these tools reduce the number of physical experiments needed while increasing confidence in your formulation and manufacturing strategy.
This enables you to:
Screen formulation space rapidly without consuming precious API
Predict manufacturability, performance and stability before committing to a process route
Validate digital twins at pilot and production scale
Support real-time release testing (RTRT) with mechanistic dissolution models
-
Every processing route, from first milligram to pilot scale
Our integrated facility spans the full drug product manufacturing landscape — from raw material characterisation and feeding through to granulation, tableting, hot melt extrusion and 3D printing. Whatever your processing route, we have the equipment, expertise and research depth to support it.
-
Scientists who work on your problem, not just your samples
Our scientists design studies around your specific formulation and manufacturing challenges — interpreting data, connecting results to your development decisions and drawing on the full breadth of CMAC's expertise. We work with academic groups and industrial partners across sectors, from early exploratory research to focused technical problem-solving.
Core capabilities:
-
Know your material before you process it.
Characterising raw materials and blends is a critical first step in ensuring manufacturability and drug performance. Understanding material properties enables smarter process selection, formulation decisions and performance prediction, before any large-scale processing begins.
We provide:
Powder flow, particle size and density analysis
Surface and moisture characterisation
Thermal and rheological analysis
In-line process analytical technologies (PAT), including spectroscopy and imaging
-
Accelerating development through data-driven insight.
AI and machine learning-enabled predictive models
Formulation optimisation using minimal material (<25 g)
Scale-up modelling and digital twin approaches
Stability and dissolution prediction
-
Bridging lab scale to industrial reality
Feeding and blending are common to almost every formulation route, and failures during scale-up are a significant source of development delays. Our research focuses on understanding and mitigating those risks — from low-quantity experimentation through to pilot and industrial scale.
Our bespoke CMAC MicroFeeder delivers consistent feeding of cohesive, poorly flowing pharmaceutical powders at rates below 10 g/h — a scale where no commercial feeder previously operated reliably.
Pilot-to-industrial scale feeding systems
Low- and high-shear blending technologies
Expertise in scale-up and process troubleshooting
-
Dry, wet and melt routes, across all scales
Granulation improves the flowability, compressibility and uniformity of powder blends by agglomerating fine particles into larger, cohesive granules. The appropriate mechanism — dry, wet or melt, depends on material properties, binder choice and process requirements.
Dry, wet and melt granulation
Batch and continuous processing options
Integrated milling from lab to industrial scale
-
From gram-scale simulation to self-driving manufacture
Direct compression remains one of the most widely used production methods for oral solid dosage forms. Our capability combines conventional tablet press equipment with highly innovative gram-scale simulators and a first-of-its-kind self-driving manufacturing and testing platform.
Using fewer than 500 g of formulation, the Expo FFSim feedframe simulator captures the lubrication sensitivity effects that typically only emerge at industrial scale, including tensile strength reductions of over 60% from R&D to industrial feedframe speeds.
Our automated robotic direct compression platform represents a step-change in formulation development — autonomously executing manufacturing and testing cycles, reducing manual effort and enabling far more data-rich design of experiments than conventional approaches allow.
-
Unlocking poor solubility
Poor aqueous solubility is one of the most common challenges facing modern drug development, with a growing proportion of new candidates classified as BCS Class II or IV. Hot melt extrusion (HME) is the primary manufacturing method for amorphous solid dispersions (ASDs) — the leading strategy for improving the solubility and bioavailability of these compounds.
Our DDMAP research programme has built a mechanistic understanding of amorphous pharmaceuticals and a suite of predictive tools for forecasting ASD formation, structure, performance and stability — from under 100 mg of API. The ASD screening data factory can evaluate a full polymer screening set at this scale, dramatically reducing the material cost of early formulation decisions.
Our in-house developed filament-free 3D printer removes the mechanical property constraints of conventional fused filament fabrication, opening pharmaceutical 3D printing to a much wider range of simple binary formulations — including materials previously considered non-printable.
-
Confirming quality before it becomes a problem
Drug product characterisation confirms that the physical, chemical and biological properties of a finished dosage form meet quality and performance requirements. Our suite connects structural and surface analysis to functional performance testing — giving you a complete picture of your product.
Conventional dissolution testing tells you when a drug releases. Our multi-modal dissolution system shows you how — with real-time, high-resolution imaging of dissolution and disintegration events integrated directly into the measurement. This mechanistic visibility transforms dissolution from a pass/fail test into a formulation development tool.
High performance drug product processing platforms
-
HAAKE™ MiniLab 3 Microcompounder
Micro-scale twin-screw compounder for hot melt extrusion, melt granulation and in-process rheological measurement.
Enables formulation screening and processability assessment at gram scale with minimal API consumption.
-
Thermofisher Process 11 and Process 16
Pilot-scale twin-screw extruders for continuous HME and wet granulation. Supports batch-to-continuous process development and comparison, with full PAT integration capability.
-
Alexanderwerk BT120 Roller Compactor
Pilot-scale dry granulation via roller compaction, with integrated milling at lab, pilot and industrial scale.
Supports end-to-end dry granulation process development and scale-up.
-
Expo FFSim Feed Frame Simulator
Gram-scale simulation of industrial feed frame behaviour, enabling quantification of lubrication sensitivity and feedframe effects on tablet quality — with fewer than 500 g of formulation.
Captures industrial-scale phenomena without industrial-scale material requirements.
-
CMAC MicroFeeder
CMAC-developed feeder delivering consistent flow of cohesive pharmaceutical powders at rates below 10 g/h.
A double-screw agitator controls flow rate; the feeding screw minimises variation — enabling reliable continuous feeding at scales inaccessible with commercial equipment.
-
Filament-free 3D printer
CMAC-developed fused filament fabrication system that removes the mechanical property constraints of conventional filament feedstock.
Enables pharmaceutical 3D printing with simpler binary formulations and materials previously considered non-printable.
-
Multi-Modal Dissolution Testing System
CMAC-developed bathless direct-heating dissolution vessel integrated with optical coherence tomography and UV-VIS spectroscopy.
Provides real-time, high-resolution imaging of dissolution and disintegration events, with a bespoke sample holder for consistent, reproducible positioning.
-
Self-Driving Manufacturing and Testing Platform
A first-of-its-kind automated platform the Tableting CMC DataFactory plans, executes and evaluates direct compression manufacturing cycles without manual intervention.
Dramatically expands the experimental space available in a given timeline, enabling formulation strategies that conventional approaches cannot efficiently explore.
Applications and impact.
We work with pharmaceutical companies, biotech organisations and academic groups across the full spectrum of drug product development challenges.
Bioavailability enhancement for poorly soluble drugs via amorphous solid dispersions
Oral solid dosage form development — tablets, granules, capsules and printed forms
Continuous manufacturing process development and batch-to-continuous transfer
Scale-up risk assessment from lab to pilot to industrial scale
Lubrication, feedframe and compaction sensitivity studies at minimal material consumption
Drug product characterisation to support regulatory submissions and product understanding
Bespoke challenge-solution projects for specific formulation or manufacturing problems not addressed by existing research programmes
Academic and industrial collaborative research across pharmaceutical sciences and related fields
Get in touch
