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

Biopharma Group scientists can work across a variety of industries & products, including:

Product Drying Methods:

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

  • Pallavi Pradeep
    "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."
    Pallavi Pradeep
    Evelo Biosciences - USA
  • Tímea Tari
    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.
    Tímea Tari
    Richter Gedeon Nyrt, PhD, Biotechnology Formulation Development Group, Hungary
  • Yiğit Öztunaoğlu
    The course was really engaging; It was interesting and I gained general knowledge about freeze drying process. I highly recommend it.
    Yiğit Öztunaoğlu
    Lab Business Development Manager, Istanbul, Turkey
  • Giuliana Vozza
    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.
    Giuliana Vozza
    PhD, Scientist, AstraZeneca, Ireland
  • Asif Muhammad
    “All presenters were very knowledgeable and delivered course contents really well.”
    Asif Muhammad
    Advanz Pharma, UK
  • J. O'NEILL MPM, PMP

    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.

    J. O'NEILL MPM, PMP
    Project Manager HSDx - Waters Technologies, Ireland.
  • Y. BRAUN

    …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.

    Y. BRAUN
    Project Manager - Vibalogics (Germany)
  • HEMANT PATIL

    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.

    HEMANT PATIL
    Research Scientist - Sai Life Sciences Ltd, India