Company insight
What you qualify is what can be scaled
Onno Visser, site manager, CaP Biomaterials, explains how decades of experience scaling calcium phosphate manufacturing processes are put to work for R&D projects.
T
he problems we are called in to solve are rarely bench problems. They sit between the bench and the first commercial batch, and the pattern is familiar to anyone who has taken a bone void filler product through regulatory approval and market release. The material performs well in early samples. The team freezes the design, builds the submission and starts planning launch quantities. Then the first production run comes back and something is not quite right. Controls may be required, specifications expanded, handling feels different and larger quantities do not behave like the small batches the team qualified. Fixing that gap can become more complicated than the development cycle, with quality questions sometimes harder to resolve than engineering ones.
That gap is not a materials science problem. It is a development and manufacturing problem – and it usually traces back to one thing: initial samples were made on laboratory equipment, while scaled production did not exactly replicate that material.
A commitment to quality At CaP Biomaterials (CaP), every sample is made on production- scale equipment in our 20,000ft2 manufacturing facility in East Troy, Wisconsin, US. What a customer qualifies is what that customer scales, controlled through our ISO 13485:2016-certified quality management system. The formulation that performs well in sampling is made the same way, on the same equipment, as the batch shipped years later. We work closely with the customer’s research and development (R&D) team through iterative sampling, jointly defining specifications for raw material and device performance. Porosity, density, surface area, particle size and other critical properties are optimised to the requirement, so you are never limited to standard options.
www.medicaldevice-developments.com
Calcium phosphate powder from CaP Biomaterials. For 20 years, the company has made hydroxyapatite, TCP, and biphasic bioceramics under an ISO 13485:2016-certified quality system.
CaP manufactures hydroxyapatite, alpha tricalcium phosphate (TCP), beta TCP, tetracalcium phosphate and biphasic calcium phosphates as powders, granules and porous blocks. Doped and substituted formulations, patented materials and processes, proprietary composites and recently added calcium sulphate capabilities are available for customers looking beyond the standard range. Manufacturing happens under an ISO 13485:2016-certified quality management system, giving customers full lot traceability and technical documentation built to support regulatory teams, Food and Drug Administration Master Files and CE submissions. In-house analytical capability includes X-ray diffraction, fourier transform infrared spectroscopy, particle size measurement, and solubility and dissolution testing to norms including ASTM F1926, ASTM F1185 and ISO 13779. These services support development, quality control and stand- alone contract testing.
Over the years CaP has invested heavily in capacity and redundancy. Two spray dryers operate, with powder batch
capability ranging from prototypes through 600kg commercial production batches. Supply agreements that include safety stock for raw materials and finished product help ease supply concerns.
Manufacturing excellence CaP Biomaterials is a specialised, dedicated contract manufacturer. We do not market devices of our own, and we do not compete with the companies we serve. Customer materials are used worldwide in orthopaedic, spine, dental and trauma applications, including hydroxyapatite coatings, bone void fillers as granules, strips and putties, calcium phosphate cements, additive manufacturing feedstock and bioabsorbable polymer devices. Customers range from start-ups and scale-ups to established orthopaedic powerhouses. After 20 years, the proposition remains clear: get the material right for the device, make it the same way every time at the scale the customer needs and ensure the documentation supports demanding regulatory requirements. ●
www.capbiomaterials.com 79
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