Diagnostic CDMO Services

Developing high quality, resilient and scalable freeze dried and liquid formulations is vital for companies operating in the increasingly competitive global diagnostics industry. It is equally crucial that they launch these products to market as quickly and seamlessly as possible.

Biopharma Group provides a host of research and development (R&D), consultancy, and manufacturing services, which combine to enable you to swiftly produce robust and accurate products at scale. Through our versatile CDMO solutions, our expert scientific team can help you to reduce cold-chain logistics, optimise product performance, and extend the shelf life of your products.

Our end-to-end CDMO services support you throughout every step of your product’s development – from product assessment, proof of concept and formulation development to cycle development, troubleshooting, and scale up, technical transfer and manufacturing.

>> Read our Diagnostics CDMO Services Brochure

Why Choose Biopharma Group?

With over 35 years of freeze-drying experience, Biopharma Group is widely recognised as an industry leader in lyophilisation. Having completed over 4000+ projects across 30 countries, our team has the expertise, flexibility and capacity to meet your company’s specific requirements. Across these projects, our R&D services have delivered an average reduction of 80% in product storage costs for our customers, while decreasing their production costs by an average of 60%.

We were also a leading manufacturer of diagnostic tests for the UK’s National Health Service (NHS) throughout the COVID-19 pandemic. During which, we produced more than 2.5 million tests per month from 2020 to 2022.

By partnering with us, you can benefit from:

  • Full intellectual property ownership (IP): Your organisation maintains full ownership of any products, processes, and IP created during the partnership. This provides you with complete autonomy over the project’s outputs and innovations, allowing you to implement these into your operations, audits, business strategy and brand identity. 
  • Assured compliance with IVDR: Our team has deep domain knowledge of in-vitro diagnostics for the point of care (PoC) sector. We provide expert advice and guidance on complying with the European Union’s In Vitro Diagnostics Regulation (IVDR), which is a required standard for all molecular diagnostics companies operating within the EU.
  • Flexible production capacity: From one-off pilot-scale R&D work scopes to large-scale continuous production operations, our team has the agility and capacity to accommodate your project’s requirements.
  • Secure worldwide shipping: We provide secure global shipping for all freeze-dried and liquid formulations. Our team can support a wide range of temperature levels – from -80°c to ambient temperatures.
  • ISO accreditation: Biopharma Group is accredited to ISO 13485 and ISO 9001, ensuring full compliance with quality management regulations.
  • Competitive pricing: Our CDMO diagnostics services are competitively priced, helping you to minimise your supply chain costs.
  • Industry-leading innovation: Our scientific team was one of the industry’s leading innovators in lyobead technology. We continue to play an important role in evolving the technology to provide customers with accurate, fast, and cost-efficient lyobead generation services.
 

Equipment for
all your needs

 

Equipment for
all your needs

 

R&D / Analytical Services

- Process & Analytical Technology Services
- Analytical Lab Services
- Collaborative Research Services-up
- Specialist analytical services – FDM, DVS, SEM, XRD 
- Consultancy and troubleshooting

Diagnostics Manufacturing

- Contract freeze drying for lyocakes
- Lyobeads technology
- Quality Control & ISO 13485 Compliance
- Packaging & kitting services 
- Packing service for non-standard products

 

Don’t Just Take Our Word For It

  • ISO Lead Auditor
    I couldn’t fault Biopharma Group's QMS system as the system is robust, up to date and maintained.
    ISO Lead Auditor
  • ISO Auditor
    Well done – John has been doing these audits for years and to achieve a result like this, is commendable
    ISO Auditor
  • CEO
    “I wanted to express our sincere appreciation for the excellent service provided by you and your team throughout our recent project. We are particularly grateful to Bhaskar for his outstanding support—his patience in explaining the process and results was invaluable, and his kind and accommodating demeanor made all the difference. He was always making himself available for discussions, and we truly appreciate that. We will certainly reach out to you when we embark on new relevant projects. Thank you once again for your exceptional service.”
    CEO
    Biotechnology Company - Norway
  • Research & Development
    "I joined this course to improve my knowledge of freeze drying. I wish I could have done it years ago! During this course, the complex process of freeze drying has been presented in a polished and proficient manner by obvious experts in the field. The course content has covered every aspect of the subject and I feel that I have a more in depth understanding of the whole process. I thank the presenters for an outstanding course."
    Research & Development
    Evik Diagnostics
  • Lab Scientist
    "We are outsourcing our product for testing often […] and getting the satisfactory results from [Biopharma Group] the company; also availing the additional benefits. We are assured to continue the same rapport with your esteemed organization. Thank-you for your timely support. It's our pleasure to outsource the products for testing with your esteemed and well-established organization."
    Lab Scientist
    Sai Life Sciences Ltd. India
  • CEO
    “TherageniX has benefited from Biopharma Group services to develop a formulation suitable for lyophilisation. The project involved a freeze drying cycle and a series of analyses for stability studies. Both technical and commercial support has been very appreciated”
    CEO
    TherageniX
  • Director
    “Thank you for being so professional, helpful, innovative and friendly. We were extremely impressed with the quality of your service.”
    Director
    Oxford MediStress
  • Research Scientist
    "Through my experience of working with Biopharma Group on various lyo projects, I can happily say that I have always been super impressed with the results that we have received! We will definitely continue to make Biopharma Group our first choice when needing to outsource freeze drying support"
    Research Scientist
    Nanopharm
  • Galien
    "We have had the opportunity to work with Biopharma Group on several projects to optimize and improve freeze-drying processes. Biopharma Group has real expertise that is put to the benefit of its customers. The responsiveness of their teams and the tools used have always been highly appreciated."
    Galien
    Industrial Development
  • Product Development Scientist
    "Biopharma Group always offered fast and reliable results in our Freeze Dry Microscopy studies. Big thanks for a great team!"
    Product Development Scientist
    Teva
  • Scientist
    "All presenters were very knowledgeable and delivered course contents really well."
    Scientist
    Advanz Pharma