Company insight
Particular expertise, manufacturing excellence
Calcium phosphates has been used as a bone substitute in procedures for decades. But recent advances have led to numerous improvements in current applications, as well as completely novel products. Progress like this requires a supply partner with the same drive for innovation. Managing director Onno Visser, tells how CaP Biomaterials provides value in the R&D and commercial phases of product development.
What are the core competencies in the contract manufacturing market? Onno Visser: Our new slogan, “particular expertise, manufacturing excellence”, captures it well. CaP Biomaterials offers customers direct access to deep expertise in the contract manufacturing of calcium phosphates powders and granules by leveraging a team of technical experts and highly specialised manufacturing capabilities and quality management systems. Having access to this particular expertise during the R&D phase and beyond to leverage CaP’s engineering know-how and manufacturing skills allows customers to lower the overhead costs for their commercial production phase.
Which customers can benefit from CaP’s products and services? Any customer looking to develop medical devices that contain calcium phosphates, but also companies that are having issues with existing calcium phosphate supplies. Many larger companies are looking to de-risk their supply by adding second or even third suppliers, sometimes looking for a geographical and currency diversity in their supply base. We invest time and resources in working with start-ups that have a good understanding of the market and a solid concept to bring novel products to market, including bone void fillers, bone cements and hydroxyapatite (HA) coatings. Increasingly, device companies and HA coating manufacturers utilise CaP Biomaterials’ testing capabilities, including dissolution and solubility testing. We’re planning further investment in these areas in the coming years to better serve this customer base.
How have recent trends in contract manufacturing led to changes that add value to this customer base? CaP benefits from the growing realisation that outsourcing non-essential activities is
a healthy choice for device manufacturers, freeing up their resources and allowing them to focus on those activities that deliver maximum added value. CaP has invested several millions of dollars in a recent expansion that is able to manufacture high-volume products in large batches and includes a large “white room”, capable of classification as a Class 7 cleanroom . The modular approach to the architecture of our manufacturing space means we can scale up quickly or add customer-specific suites for those customers looking to have their own dedicated areas.
How does CaP Biomaterials innovate to stay ahead of its competitors? CaP is immersed in innovation in several ways. We have customers with a fully developed device or an advanced concept that is already patented, and they will ask CaP to scale up their calcium phosphate manufacturing process. This can be a puzzle because this type of material can be challenging to scale without changing its properties. In addition, CaP Biomaterials has patented its own novel manufacturing methods and materials, assessed in vitro and in vivo to provide insight on their suitability and potential in medical devices. Currently, we have customers developing putty products that contain such patented materials. They’re seeing the exact biological response and handling capabilities they were looking for, with the added value of having patented components in their product.
Do clients get more value if they involve its experts in the early stages of product development? It’s like super charging your development. Right from the start, you have access to materials that have been manufactured with all the required process controls in place, on the same full-scale equipment that will be
Medical Device Developments /
www.nsmedicaldevices.com
required in the final manufacturing phases. CaP can suggest and perform material characterisation, such as specific surface area, SEM, infrared and XRD analysis, and can supply customers with a range of materials to test in their product formulations. Recently, we had a customer test a specific material sintered at four different temperatures, all potentially resulting in different biological and handling characteristics. At the end of development, when the customer freezes their overall design, the time pressure is quite significant. Getting it right from the start and knowing there will be no scaling issues adds tremendous value, as does knowing that your supplier is ISO 13485 certified.
Did the pandemic have a significant impact on the supply chain? Necessity is the mother of invention. There were some close shaves, but in the end CaP managed to resolve issues before customers were affected. In some cases we started manufacturing or optimising raw materials in-house, and worked closely with customers to assure such changes were handled appropriately. Investment in significant safety stocks for raw materials, intermediate and final product, and actively discussing stock levels and forecasting with customers has minimised the potential for supply chain disruptions.
Have advances in bone healing led to new applications for products? We are working with several companies that are active in the development of bio-inks as well as additive manufacturing of implants. It’s fascinating to see this new field develop and make progress towards new applications, all enabled through recent scientific and technological advancements. ●
www.capbiomaterials.com 101
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