Service & Solutions
Average reduction in length of lyo cycle after R&D support
Average increase in productivity after R&D support
Average reduction in cost of storage after R&D support
Average reduction in cost of production after R&D support
Biopharma Group is ISO:9001 & ISO:13485 Accredited
More Information
R&D Services/Analytical Lab Services
Biopharma Group’s contract R&D services focus on freeze drying (dried product) and liquid formulation development – allowing us to offer a comprehensive range of expert led CDMO services. Analysis options include comparable process studies, formulation & cycle development, process reviews/audits, optimisation and scale-up that incorporate PAT (Process Analysis Technology) for risk-based quality assurance.Our team of CDMO specialists understand the importance of creating an optimised product and process in the early stages of a project development cycle and tailor’s solutions to specific project requirements.
Pre-Clinical & Aseptic Fill-Finish Manufacturing Services
Clinical Pharma Manufacturing: Available late 2025, Biopharma Group’s new aseptic fill-finish clinical manufacturing facility is set to provide a much-needed resource to pharmaceutical companies needing small batch clinical production facilities for first-in-human trials. The integration of a new Annex 1 compliant, clinical manufacturing facility into our CDMO services will provide freeze drying for up to 3200 2R vials in our state-of-the-art ATS Hull freeze dryer – alongside Grade A isolation facilities in a cleanroom environment for the sterile production of both liquid and lyophilized products such as ADCs, cytotoxics and other HPAPIs.
Pre-Clinical Manufacturing: We offer flexible and scalable CDMO services for clients seeking formulations that don't require the stringent GMP standards. This versatility is valuable for research, development, and production of non-sterile products across diagnostics, pharmaceuticals, and biotechnology. Whether it's pilot-scale development or larger non-sterile production runs, our services adapt to the unique demands of each project.
Lyobeads Processing
Lyobeads, aka lyophilized spheres, have become a popular technology in the field of freeze drying to the diagnostics industry - as the primary advantage is their flexibility in formulation. They allow for the development of a single formulation that can be easily adjusted for various applications, even in different container types. This versatility can significantly reduce research and development (R&D) investment, making lyobeads an attractive option for companies looking for diagnostic and manufacturing assistance.
Biopharma Group has been at the forefront of lyobead processing evolution, supporting many customers to increase productivity whilst achieving significant cost and time savings.
Industry Applications - Diagnostics, Pharma and Biotech
Diagnostics: Our CDMO specialists are experts in formulation development and lyophilisation processes. This means that the lab teams at Biopharma Group have the capability to support the creation of stable and efficient diagnostic reagents and test kits, enhancing the accuracy and reliability of diagnostic tests.
Pharma: Our QbD methodology and DoE principles are instrumental in optimising drug formulations, enabling pharmaceutical companies to develop products more rapidly and cost-effectively.
Biotech: Our services facilitate the development of biologics, including vaccines and biopharmaceuticals. We contribute to the advancement of biotechnology by providing the necessary expertise and infrastructure for the efficient and compliant production of these critical products.
Quality by Design (QbD) and Design of Experiment (DoE)
Quality by Design (QbD) is revolutionising pharmaceutical development by replacing traditional trial-and-error methods. As part of our CDMO services Biopharma Group champions this approach - significantly reducing the number of developmental cycles needed for formulation and lyophilisation process optimisation.
QbD's precision and predictability benefit a broad spectrum of pharmaceutical products, including small and large molecules and biologics. Biopharma Group's CDMO services aim to define design spaces and critical process parameters, ensuring compliance with stringent regulatory standards.
As CDMO specialists, our expertise results in efficiency and cost savings - exemplified by a 60% reduction in investment for a client's lyophilisation process through utilising a QbD approach.
Low Bio-Burden Labs
Biopharma Group is at the forefront of pharmaceutical research and development, boasting three in-house, state-of-the-art low bio-burden labs. These facilities demonstrate our commitment to precision and safety in lyophilization processes and the manufacturing of dried and liquid formulations.
Equipped with cutting-edge technology and maintained to the highest industry standards, our low bio-burden labs are the cornerstone of our mission to deliver excellence in pharmaceutical solutions.
ISO 13485 Accreditation
Our ISO 13485 accreditation is a testament to Biopharma Group's commitment to quality and compliance as a provider of CDMO services. This certification ensures that our processes, from research and development to manufacturing, adhere to the highest global standards.
As a Contract Development and Manufacturing Organisation (CDMO), Biopharma Group's ISO 13485 accreditation is your assurance of quality, precision, and regulatory compliance in every aspect of your project.
With this accreditation, we can seamlessly integrate our services into your lyophilization requirements and samples development, ensuring a smooth and compliant journey from concept to market.
Accreditatons:
Don’t Just Take Our Word For It
We have been working with Biopharma Group for some critical project tasks in relation to the lyophilisation of our product. We are very pleased with the excellent work that the Biopharma team have completed so far. The level of expertise at Biopharma Group has allowed us to make substantial progress in a short amount of time, in addition their overall communication and commitment to the project has been fantastic. I would highly recommend working with Biopharma Group for any lyophilisation-based projects.
CTO
Altach BiomedicalThank you all, especially Niloo and Emma, for a super informative day! I really enjoyed getting to know your technology and was made to feel so welcome at your premises! It always makes for a great experience to see such passion for science and high quality services.
N. Hudson, PhD
Principal ScientistReally successful collaboration – happy with services provided. Biopharma Group were attentive, responded quickly & provided a successful cycle!
R&D Supervisor
ThermoFisher
I couldn’t fault Biopharma Group's QMS system as the system is robust, up to date and maintained.
ISO Lead Auditor
Well done – John has been doing these audits for years and to achieve a result like this, is commendable
ISO Auditor
“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"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"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“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“Thank you for being so professional, helpful, innovative and friendly. We were extremely impressed with the quality of your service.”
Director
Oxford MediStress"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"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"Biopharma Group always offered fast and reliable results in our Freeze Dry Microscopy studies. Big thanks for a great team!"
Product Development Scientist
Teva"All presenters were very knowledgeable and delivered course contents really well."
Scientist
Advanz Pharma
