15+
Areas of Expertise
30+
Countries Supported
3,000+
Formulations Developed
30+ Yrs
in Freeze Drying
Contract Research & Manufacturing Services
Biopharma Group provides tailored product and sample drying process solutions to best meet your desired end product requirements, 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 and spray drying across our dedicated in-house scientists, which has continually evolved over more than 30 years, making Biopharma Group recognised as a worldwide hub for drying process related projects.
With each product and process recognised as unique, by entrusting us with your project, 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. 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:
Contract Research & Development
Contract Manufacturing
Contract Packaging & Assembly
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 dedicated cytotoxic facility accommodates projects with sensitive samples and/or, that require product specific handling. Take a look at some of our contract R&D lab services below:
Freeze Drying Process Phases
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)
- SEM
- XRD
Analytical R&D Lab Services
Biopharma Group's in-house scientists can de-risk your freeze dried, spray dried and liquid formulation product R&D. Here are some of the lab service and analysis 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 & Sensitive Sample Handling/Processing
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 across a variety of industries & products, including:
DIAGNOSTICS
PCR & lamp products
Antibody tests
Fluorescent probes
Mastermixes
PHARMACEUTICALS
Small molecules
Proteins
Cytotoxic compounds
Vaccines
Antibodies
Antibiotics
Conjugated compounds
BIOTECH
Collagen
Hydrocolloids
Liposomes/Exosomes
Human tissues
Cells & bacteria
Product Drying Methods:
LYOCAKES
Within formats:
Vials & stoppers
Well plates
SPRAY DRYING
For robust products & samples
LYOBEADS
Within formats:
Vials & stoppers
Tubes
Well plates
R&D analysis and consultancy services available per processing stage include:
Lyobeads
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:
Contract Manufacturing of Liquid and Freeze Dried Products
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.
Our extensive freeze drying capabilities in our ISO 13485 accredited diagnostics production facility, 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 multiple freeze dryers in-house, ranging from benchtop freeze dryers to pilot R&D freeze dryers, as well as a dedicated spray dryer..
The Process Stages:
Contract Freeze Drying Process for Lyocakes:
Contract Drying Process for Lyobeads:
Contract Spray Drying Process:
Other Ways We Can Help:
Bespoke packing & kitting services
For in-vitro diagnostics
Non-standard products packing service
Available upon request
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 production and assembly capabilities for packaging your products, whether liquid formulas, lyocakes, lyobeads or powdered samples in vials with stoppers , or well plates are also available to you as a full end-to-end solution. 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 full development services 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.
When Biopharma Group expanded its facilities, we also took the opportunity to expand ways in which to help our customers even 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.
TESTIMONIALS
DECADES OF PRACTICAL PROCESS EXPERIENCE
