Contract Research & Manufacturing Services
Biopharma Group provides tailored drying technology solutions for your product and process, from proof of concept studies, through formulation development, pre-and post process reviews, analysis to manufacturing. This expertise is guided by expert knowledge in freeze drying and spray drying, which has continually evolved over more than 30 years, making Biopharma Group recognised as a worldwide hub for drying related projects.
With each product and process recognised as unique, by entrusting us with your project, you will benefit from our depth of experience and knowledge to ultimately reach any project goal. Each project will be carefully managed by Biopharma Group’s team of scientists and consultants. Through the operation of proprietary and advanced equipment, both R&D and manufacturing activities will run efficiently.
Biopharma Group is your strategic processing choice, with our services able to be categorised in to three key areas:
Freeze Drying Process Phases
Areas of Expertise
in Freeze Drying
Contract Research & Development
Contract Research in Freeze Drying, Spray Drying and Liquid Formulations
Biopharma Group’s contract R&D services focus on freeze drying, spray drying and liquid formulation development. Our team of specialists understand the importance of creating an optimised product and process in the early stages of a project development cycle. 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. An in-house cytotoxic suite accommodates projects with sensitive samples and/or, that require product specific handling. Take a look at some of our contract R&D lab services
Process Analytical Technology Services
To support your R&D needs, Biopharma Group can also offer some pre- & post processing analysis services incorporating PAT for a risk-based approach to quality assurance, these services include:
Pre-process for thermal characterisation and critical event behaviour determination services:
- Freeze Drying Microscopy (Lyostat FDM)
- Frozen State & Impedance Analysis (Lyotherm)
Post-process analytical services:
- Quantative Mechnical Structure Analysis (MicroPress)
- DVS (Dynamic Vapour Sorption)
Analytical R&D Lab Services
Biopharma Group's in-house scientists can derisk your freeze dried, spray dried and liquid formulation product R&D; here's some of the lab service options available:
- Proof of Concept Studies
- Comparative Process Studies
- Pre-formulation Studies
- Formulation Development
- Product Characterisation
- Cycle Development & Trials
- Process Reviews and Audits
- Stability Studies
- Optimisation and Scale-up
- Tech Transfer
- Cytotoxic Product Handling
Collaborative Research Services
Biopharma Group has collaborated and partnered with numerous companies and organisations for the development of new processing methods, applications, prototyping, in addition to the co-development of new products. In doing so, we have overcome the following challenges:
- Lyobead processing technology development
- Development of lyophilised diagnostic tests
- Regenerative medicine: freeze-drying human blood for long-term storage
- Regenerative medicine: lyophilization of collagen matrices for regenerative cartilage repair
The IPRs (Intellectual Property Rights) derived from each project are always agreed prior to works commencing within the framework of the collaboration agreements.
Contact us to confidentially discuss your project requirements.
Biopharma Group scientists can work with a variety of products:
FOOD & NUTRACEUTICALS
Fruit & Vegetables
Meat & Fish
Early Life Products Food Supplements
PCR & Lamp products
Cells & bacteria
Stopper & Vials
...and Formats Below
Vials & Stoppers
Lyocakes & Lyobeads
Bespoke packaging service for in-vitro diagnostic products
Non-standard formats upon enquiry
Biopharma Group offers its expertise in revolutionary lyobead technology. Lyobeads are small customisable spheres of a specific volume mastermix, different from lyo-cakes, which typically appear flat and circular to fill a vial. 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 are advantageous because:
- the formulation can be easily modified for several applications
- these applications can be stored at different room temperatures
- a high throughput leads to increased manufacturing rate
- the beads are stable
- the beads have a rapid reconstitution time
Why QbD (Quality by Design) is an important element of your drying process R&D, as explained by Biopharma Group’s Dr. Kevin Ward:
Contract Manufacturing of Liquid and Freeze Dried Products
Specialists can support you with the following:
Biopharma Group offers contract manufacturing services using both freeze drying and spray drying methods; comparable studies are available to determine which drying process is most suitable for your project.
The recent four-fold increase of freeze drying capabilities in our ISO 13485 accredited laboratory, offers limitless scope for scalable, state-of-the-art manufacturing, increasing the efficiency and throughput of each batch.
If powdery material is required to be produced in a continuous mode, spray drying could be a suitable option. The continuous nature of spray drying can be extremely time and cost effective for bulk manufacturing for suitable products.
We work with small, medium and large volumes over a variety of different products and formats, including vials, tubes, well-plates, strips, bulk and beads.
By choosing to pair with our contract research, development and manufacturing services, Biopharma Group’s unmatched standards of procurement and expertise provide efficient end-to-end development support for product and process.
We have several SP Scientific dryers in-house, ranging from benchtop freeze dryers to pilot R&D freeze dryers.
The way we operate:
Contract Freeze Drying Process for Lyocakes:
Contract Drying Process for Lyobeads:
Contract Spray Drying Process:
Contract Packaging & Assembly:
Contract Manufacturing of Liquid and Freeze Dried Products
Contract Liquid Fill-Finish and Packaging
Commercialising your product? We can accommodate both liquid products through liquid fill finish services, and dried products via freeze drying and spray drying. Our producton and assembly capabilities for packaging your products, whether liquid formulas, lyocakes, lyobeads or powdered samples with stoppers and in vials, or well plates. Packaging can also include components such as medical and testing devices.
Biopharma Group’s specialists cover a comprehensive range of lyo contract R&D services including pre- and post-process analysis, additionally, we also provide end-to-end development of liquid formulation for pharmaceutical products. The team of in-house experts can help develop your early-stage R&D through collaborative consultation in order to ensure that processing helps to maximise product stability, improve shelf-life and reduce costs.
The customisable and flexible nature of Biopharma Group’s services means that the processing of your liquid formulation will be catered specifically to the needs of the desired end product. Along each step of the process, the team will be there to help you. From contract research services for formulation development and end-product goals, to scalable contract manufacturing services that can operate across small, medium or large volumes, our in-house team can create a process that can be adapted to scale-up or down to meet your needs.
Whilst Biopharma Group expanded its facilities, we also took the opportunity to expand ways in which to help our customers ever further. We can now help with the contract assembly and packaging from the preparation and dispensing into vials/well-plates, packaging and then shipping onward using our own fill-finish processing line. The Biopharma Group 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.
Biopharma Group’s dedicated production line offers a bespoke packaging and kitting service for diagnostics/ IVDs and vaccines, as well as shipment to any desired location.
DECADES OF PRACTICAL PROCESS EXPERIENCE
"Really enjoyed the switch between the chemistry and nuts & bolts during the training course. It was interesting to understand the intricacies of the instruments and its science."
The course went beyond what I was anticipating, I learned a lot and it’s going to be really beneficial in my future lab career. My favourite session was critical assessment of freeze-dried products.
The course was really engaging; It was interesting and I gained general knowledge about freeze drying process. I highly recommend it.
The course really met my expectations. I’ve got a really good fundamental understanding of freeze drying. I particularly enjoyed the good balance between theory and hands on. I would definitely recommend this course to anyone in the freeze drying industry.
“All presenters were very knowledgeable and delivered course contents really well.”
I worked with BTL and they provided an excellent service to Waters at the development phase of our project.
Both Dr. Laura Ciccolini and Mr. Nick White were very helpful and professional, [they] not only assisted me with the project but also gave me an understanding of the Freeze Drying process. The personnel at BTL are the experts in their field of freeze drying and really supportive to me as a client in our development phase and were really focused in adding value and optimising the process throughout.
I would highly recommend BTL for all Freeze Drying project and would 100% use them again.
…fast response to customer requests and provision of a quote.
Even though we had delays in confirming the order and providing the samples to btl, the analysis was conducted immediately and results provided swiftly, which is very helpful for a CMO like Vibalogics to keep our customers satisfied.
We are outsourcing our product for testing often[…] and getting the satisfactory results from [Biopharma] 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.