Biomedical Bonding AB is a Swedish MedTech company that develops cutting-edge adhesives, composites, and novel surgical methodologies with focus on the ever-growing market of hard tissue repair. Biomedical Bonding wants to overcome the current pain points in today’s bone fracture surgery and dental restorations by introducing a unique technology platform based on a novel category of adhesive resin-composites with focus on biocompatibility, tissue-friendliness, and high mechanical strength.
By working with Medace they are taking important steps towards readying their technology for clinical use with the ambition to improve treatment and enhance the quality of life for patients. Within Medace’s cleanroom facility, they have manufactured their Bonevolent™ AdhFix implant, a customizable composite implant that can be tailored for fracture fixation, for the execution of design validation studies.
Biomedical Bonding demonstrated exceptional preparedness and readiness before commencing manufacturing at Medace. With a keen focus on quality and compliance, the team ensured that their Quality Management System (QMS) procedures conformed both with regulatory requirements and Medace’s standards. They prepared a detailed plan that considered all crucial aspects of the manufacturing process within the cleanroom environment. By meticulously documenting each step of the process and adhering to stringent guidelines, Biomedical Bonding set the stage for successful manufacturing at Medace.
Biomedical Bonding’s Chief Technology Officer Viktor Granskog along with product engineers Lola Opande and Ram Shadher, travelled to Maastricht, The Netherlands to manufacture Bonevolent™ AdhFix at the Medace facility. First, the Medace’s support team provided a comprehensive cleanroom training to the Biomedical Bonding team. The training covered a wide range of essential topics, including proper gowning procedures, aseptic techniques, equipment handling, and contamination control measures. This training equipped the Biomedical Bonding team with the necessary knowledge and skills required to operate efficiently within the cleanroom environment, ensuring their comprehensive understanding of the intricacies of controlled cleanroom operations.
Following the successful completion of the required training courses and subsequent qualification of personnel, Biomedical Bonding initiated cleanroom manufacturing within one of the ISO 8 cleanrooms. They assembled the AdhFix implant components for the purpose of the design validation studies, adhering strictly to the procedures outlined by their QMS. Their dedication resulted in the successful filling of nearly 2000 syringes and vials for the AdhFix kits within a remarkably short timeframe, superseding the set target. In addition, they gathered important data and confirmation of manufacturability of their product.
“- It is inspiring to see how dedicated the team is and I am extremely proud of the excellent execution. The team has delivered on key milestones with remarkable precision. Amazing!”
Evelina MikaelsonCEO Biomedical Bonding AB
About Biomedical Bonding AB
Biomedical Bonding AB is a Swedish MedTech company that develops cutting-edge medical adhesive fixators and novel surgical methodologies with focus on the ever-growing market of hard tissue restorations. The technological platform, Bonevolent™, is market disruptive and stands for a paradigm shift in personalized surgical interventions. Biomedical Bonding´s vision is to become the dominant global provider of unique adhesive products suited for fracture fixation and dental restoration market. Biomedical Bonding is a privately held company headquartered in Stockholm, Sweden.
For more information, please contact:
Evelina Mikaelson
CEO Biomedical Bonding AB
Phone: +46 763 422 824
Email: Evelina.mikaelson@biomedicalbonding.com
Homepage: www.biomedicalbonding.com
About Medace
Too many promising medical innovations never reach the patient due to the ever more stringent and difficult landscape of Medical Devices and Advanced Therapy Medicinal Products legislation and technical validation.
We offer a work-learning environment that allows you to develop your technical product dossier needed for clinical validation. At the same time we guide you in how to produce your product according to the GMP and ISO requirements and offer you the GMP and ISO cleanrooms to produce your own product.
Medace works with an EN ISO 13485:2016 certified quality and service package that is available to our customers.
Medace offers:
- Specialized infrastructure (including ISO8 and 7, and GMP class C and B clean rooms)
- Validated and specialized equipment
- Office environment
- Quality management system
- Trained professionals for hands-on guidance and support
- Dedicated internal training programs
For more information, please contact:
Kurt Gielen
CBO Medace BV
Phone: +31 6 1927 1669
Email: kurt.gielen@medacespace.com
Homepage: www.medacespace.com
