Diagnostic CDMO Services

Biopharma Group has the capability to offer a range of R&D to production CDMO services to a global diagnostics customer-base – from reconstitution to friability, our CDMO and contract freeze drying services for the diagnostics sector aim to provide clear insights on the robustness, solubility, and integrity of many formulations.

Using MDSC and Karl Fisher titration techniques, Biopharma Group is equipped to perform deep, investigative research into the liquid and dried formulations that you may have developed independently or alongside us – to provide expert insight into quality control, state, and the recommended processes for your product.

With a comprehensive range of advanced analytical tools, our contract freeze drying facilities can provide invaluable support for critical phases of product development - these include:

  • Lyostat freeze drying microscopy (FDM): Freeze drying microscopy is utilitised to enable precise identification and recording of critical events and collapse temperatures.
  • Lyotherm frozen state analyser: This combines electrical and thermal techniques – allowing two analyses to be conducted simultaneously to conduct the analysis and measurement of glass transition, eutectic, and melting temperatures before freeze-drying. The integration of modulated differential scanning calorimetry (MDSC) further enhances the understanding of thermal properties throughout the process. 
  • MicroPress post-lyo process assessments: As a mechanical propoerty analysis, this instrumentation is used during post-lyo analysis to determine the quantitative mechanical properties of lyocakes and lyobeads using a linear actuator to determine strength and robustness for safe handling and shipment.
  • Karl Fischer Titration: We employ this to ensure quality control by measuring residual moisture content post freeze-drying, while Dynamic Vapour Sorption (DVS) offers insights into a material's moisture sorption properties.

Biopharma Group also has the ability to produce lyobeads - freeze-dried spheres of customisable material. Lyobeads are created through snap freezing and feature larger surface areas compared to standard lyocakes - accelerating the reconstitution process, further highlighting Biopharma Group’s commitment to enhancing the efficiency and effectiveness of diagnostic and pharmaceutical R&D.

Download a copy of our "Diagnostics Services & Solutions: From Research & Development to Manufacture" Overview Brochure

Our Diagnostics Production Credentials:

  • 15 in-house freeze dryers from benchtop, to Pilot R&D to commercial scale, we have capacity for one-off batch runs, through to on-going production
  • Greater than 10²m of freeze drying shelf space
  • Capacity to run batches from 1 plate to 150 plates in a single machine – in 96 well plate or tube format
  • Secure worldwide shipping from -80°c to ambient temperatures
  • More than 2.5 million Covid tests produced per month during the peak Covid-19 period of 2020-2022
  • Leading manufacturer of diagnostics supplied to the NHS during Covid-19 pandemic
  • Biopharma Group was instrumental in the evolution of using lyobead technology for fast-turnaround, cost efficient, precise dosing and easy to reconstitute.

 

Diagnostics Manufacturing

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


R&D / Analytical Services

- Formulation & lyo-cycle development
- Proof of concept studies
- Design space, tech transfer & scale-up
- Material characterization
- Specialist analytical services – FDM, DVS, SEM, XRD 
- Ad hoc consultancy

Don’t Just Take Our Word For It

  • 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