Lyophilisation, or freeze-drying, is a complex process that requires careful control and optimisation to achieve the desired product quality. In the diagnostics sector, where products often have specific requirements and complex formulations, it is crucial to partner with a CDMO that has the necessary expertise and experience in lyophilisation.
A CDMO partner can provide valuable assistance in optimising the lyophilisation process, ensuring product stability and activity, and scaling up production while maintaining quality. When choosing a CDMO partner for your diagnostics product, it is important to consider their experience, capabilities, and track record.
CDMO lyophilisation: proven expertise
Biopharma Group has a long history of providing contract research, development, and manufacturing services to the pharmaceutical and diagnostics industries. A team of experienced in-house scientists and engineers, along with a wide range of dedicated equipment, instruments and cleanrooms, can help you with all aspects of the lyophilisation process, from cycle development and scale-up to troubleshooting and optimisation.
In addition to technical diagnostic CDMO expertise, Biopharma Group also offers advantages to clients including a commitment to quality and service delivery with ISO9001 and ISO13485 accreditations, a flexible and collaborative approach, and a global network of partners and suppliers.
With the team’s expertise, and commitment to excellence, Biopharma Group is helping clients bring their diagnostic products to market quickly and efficiently via a variety of services, including:
- Lyophilisation and liquid formulations cycle development and optimisation – lyobeads and traditional lyocakes
- Scale-up and technology transfer – customers retain IP ownership throughout
- Analytical testing and characterisation
- Regulatory support
The group has a proven track record of success in developing and manufacturing lyophilised diagnostic products, having helped clients to develop and launch a wide range of products in the following categories:
- In vitro diagnostics
- Point-of-care diagnostics
- Molecular diagnostics
- Companion diagnostics
