Biopharma Group, currently has three ‘Category D’ clean rooms to assist in the production of sterile formulations – positioning us as contract diagnostic manufacturers. We are able to produce dried or liquid formulations in a variety of formats, from vials to 96 well plates to creating bespoke tubing and cartridges to suit your individual needs.
Our ISO 13485 accredited diagnostics production facility offers an extensive range of manufacturing possibilities, which are capable of increasing the efficiency and stability of each batch created.
We have the capacity to work with a different range of volumes – no matter the scale - and in a different variety of formats - including vials, tubes, well plates bulk strips and beads. In comparison to other diagnostic manufacturing companies, our experts have access to 15 freeze dryers, including benchtop freeze dryers as well as a dedicated spray dryer.
More Information
Lyobeads technology:
Lyobeads - Freeze Dried Spheres for High Throughput Manufacturing
Biopharma Group offers its expertise in revolutionary lyobead technology. Lyobeads are achieved through snap freezing using liquid nitrogen or polymeric gelation. Millions of reaction units a month can be produced in Biopharma Group’s laboratory.
Lyobeads technology offers numerous benefits to diagnostics sector, including:
- Improved reconstitution: The spherical shape allows a fast and homogeneous reconstitution.
- Flexibility: Lyobeads can be customised for specific applications by incorporating different reagents.
- Stability: Lyobeads are stable at room temperature and can be stored for extended periods of time, making them ideal for use in remote or resource-limited settings.
Process efficiency: As lyobeads have a larger surface area and lower volumes than traditional freeze-dried cakes, the lyophilisation process is generally quicker and more efficient.- Scalability: Lyobeads can be produced in large quantities, making them suitable for high-throughput diagnostic applications.
>> Read how investment in lyobeads technology has been a massive step forward for lyo R&D
Contract freeze drying for lyocakes:
One of Biopharma Group’s core diagnostic manufacturing offerings is contract freeze drying for lyocakes. Lyocakes are freeze dried reagents containing partial or complete regent mixtures for tests - they typically appear flat and circular to fill a vial.Our in-house team of lyo specialists understand the importance of creating an optimised product and process across all stages of a project development cycle, from proof of concept studies, through formulation and cycle development, pre-and post process reviews, analysis to production. This expertise is guided by the in-depth knowledge of freeze drying, which has continually evolved over more than 30 years, making Biopharma Group recognised as a worldwide hub for drying process related projects. Our consultancy service takes pride in tailoring solutions to specific project requirements and works closely with scientists to meet your time, cost and logistical needs.
With each product and process recognised as unique, by entrusting us you will benefit from our extensive range of experience and knowledge to ultimately reach any project goal. Every project will be carefully managed by Biopharma Group’s team of scientists and consultants.
Quality control & ISO 13485 compliance:
Here at Biopharma Group, we ensure that our diagnostic manufacturing services place the quality control of your formulations at the forefront of our processes and ISO 13485 compliant. We have a range of methods and accreditations to ensure that your liquid or lyophilised products pass our extensive regulatory checks.Packing and kitting services:
Commercialising your product?Biopharma Group's team can help with contract assembly and packaging of your product from the preparation and dispensing into vials/well-plates, to packing and kitting, then shipping onward. The team will ensure every step is processed accurately and in compliance with industry regulations, whether this is for increased shelf-life, shipping and cold-chain protocols to easy reconstitution of your liquid formulation, or for fast turnaround projects.
We have production and assembly capabilities for packaging your products in vials with stoppers or well plates as a full end-to-end solution. Packaging can also include components such as medical and testing devices.
We are also able to offer bespoke kitting and packing services that are tailored the shipping needs of your formulation – offering secure worldwide shipping from -80°c to ambient.
Our dedicated packing and shipping team are well-versed on the regulations surrounding a variety of formulations and can offer specialised advice and guidance on the best options for you.
Packing and service for non-standard products:
Have an unconventional product?Our years of expertise have enabled us to provide specialised services for a range of products, including non-standard or difficult to handle formulations.
Ask the experts
Biopharma Group specialises in contract R&D for dried product and liquid formulations of pharmaceuticals and biological materials. With specialist in-house facilities, and scientists, we can conduct an extensive range of services from proof of concept studies, through to formulation and cycle development, pre-and post-process analysis to non-GMP production for diagnostics (ISO 13485 accredited).
Soon, our GMP suite will be available to meet the requirements for small batch, first-in-human clinical trials production too. This expertise is guided by the in-depth knowledge of freeze drying, which has continually evolved for over more than 30 years – positioning Biopharma Group as a worldwide hub for drying process related projects, and most recently for improving efficiencies in lyobead processing.
Speak directly to a member of our team to better understand how our services could make us the perfect CDMO partner.
