Biopharma Technology LLC (BTLLC) is a dedicated division offering services our US customer base. In utilizing our consultancy and training expertise, BTLLC provides impartial contract research, analysis, process, product and cycle development services, training courses and analytical instrumentation for pre & post lyophilisation process analysis (Lyostat FDM, Lyotherm DTA & impedance, MicroPress for lyo cake robustness quantification and DVS analysis) to the biopharmaceutical and related process industries. BTLLC’s access to a lab in Allentown, Pennsylvania as well as Biopharma Group’s R&D analysis lab in the UK allows us to utilise the decades of experience in the application of all aspects of freeze drying technology that has been successfully applied in the processing of in excess of 2000 substances on behalf of clients.
Together with our knowledge of pilot-scale and industrial freeze-dryers, we offer a uniquely comprehensive service and training courses (scheduled or customized on-site or webinar options are available) covering all aspects of freeze drying technology from pre-formulation through to optimised scale-up and post-process, dried product analysis.
Pre & Post Lyo Process Analytical Instruments
Establishing the behavior of frozen state solutions is an essential step in many industries. Understanding the critical temperatures for each solution can improve longevity and efficacy of a product. Having detailed and clear analysis data will allow for determination of clear parameters which in turn will result in increased efficiency and productivity.
In addition to understanding critical temperatures, distinguishing the phase transitions that occur during lyophilization promotes efficiency and stability. The most effective method of determining these phase transitions is impedance analysis (Zsinφ). The Lyotherm3 is an analytical instrument for frozen state solutions that combines both electrical impedance and traditional thermal (DTA) analysis techniques allowing for greater detail and more informed decision making.
When used in conjunction with Biopharma Group’s Lyostat5 (FDM), a complete picture of the behaviour of the frozen material can be obtained. Measuring the eutectic point (Teu) and collapse temperature (Tc), the Lyostat5 establishes accurate knowledge about the product’s collapse behaviour. This is vital when developing a new cycle, scaling up or developing a formulation for lyophilization as freezing a solution at the right temperature saves time and money. Additonally, the Lyostat benefits from easily applying TASC software (Thermal Analysis Surface Characterisation) and the new modular DSC stage.
When the Lyotherm3 and Lyostat5 are combined with our impartial analytical lab services consultancy services, BTLLC is able to offer you a one-stop shop to optimize your projects success.
The unique Lyotherm frozen-state analyzer provides information about the behavior of your formulation in the frozen state, identifying changes in molecular mobility and giving an indication of thermal events such as glass transitions, crystallization events and eutectic melting.
The latst addition to the Biopharma Group portfolio of analytical instruments is the MicroPress. The MicroPress has been developed by our in-house specialists as a quantitative method for determining the robustness (Young’s Modulus) and strength (max stress at failure) of lyophilized cakes.
R&D Analytical Lab Services
Our aim is to provide a world-class service to our customers and to meet the precise needs of your projects. To this end, we will work together to agree a work programme and budget that is appropriate to the size and stage of the project, whether this be a single cycle run or individual analysis or a complete formulation development programme. Our philosophy is to augment our customers in-house expertize to make each project a success.
BTLLC offers a complete package of product & process R&D for freeze drying: process reviews, product characterization, formulation and cycle development, scale-up and optimization, and post-process characterization. Biopharma combines in-depth product characterization with an extensive understanding of product behavior and knowledge of freeze dryers to ensure your processes are suited to your development stage and equipment.
We run a separate standalone laboratory for work with cytotoxic and highly potent products.
Biopharma Group has collaborated on a range of funded research projects with academia and industry and is always keen to explore new relationships which will progress the field of lyophilization.
Lyophilisation Training Courses
Biopharma has been training users in freeze drying technology since 2000. Our lecturers are all experienced practitioners so we can make sure our training is comprehensive and practical, with knowledge gained in the field.
These courses are an ideal way to train newcomers to this field, or to build a greater depth of understanding for existing practitioners.
>>Click here to learn more about our Training Course options
Whether you are in product/ process development or production, talk to us today to find out how we can help.