Biopharma Group
Analytical Instruments
Lyostat 5 Freeze Drying Microscope
Lyotherm 3 Frozen State Analysis
MicroPress Qualitative Analysis
Differential Scanning Calorimetry (DSC) Stage
How do I improve my lyophilized products?
Biopharma has developed advanced analytical instruments – the Lyostat freeze-drying microscope , the Lyotherm DTA and impedance analyser and the MicroPress quantitative strength & stress analyser – to provide exactly these answers. During the past decade, these instruments have been improved and updated offering the latest developments in lyophilization technology that can help you reduce production time, improve shelf life, improve product appearance and much more.
Lyostat 5 Freeze Drying Microscope
The Lyostat 5 identifies critical formulation parameters including critical Temperatures for Freeze Drying. In crystalline solutions this is the eutectic point (Teu) and in amorphous products this is the collapse temperature (Tc).
Information on how the product behaves as temperature increases is vital for successful freeze drying. Product that collapses during freeze drying can suffer from a range of problems including reduced shelf life, reduced activity and poor reconstitution.
Knowledge of a product’s collapse behavior is vital when:
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Optimising existing processes
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Developing a formulation for freeze drying
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Developing a new cycle
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Scaling up
Lyotherm 3 DTA & Impedance
The Lyotherm 3 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, crystallisation events and eutectic melting by examining impedance and differential thermal analysis.
Impedance Analysis (Zsinφ) is a fixed frequency dielectric analysis providing an indication of the sample’s molecular mobility, including events not picked up by thermal methods like DTA or DSC.
Differential Thermal Analysis (DTA) measures the difference in temperature between a sample and a reference, highlighting exothermic and endothermic events e.g. crystallisation, eutectic melting and glass transitions
Combining DTA and Impedance analysis means Lyotherm is more sensitive to changes within the frozen structure than other exclusively thermal techniques.
Features & Benefits of using the Lyotherm3:
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Determines critical parameters of samples within the frozen state (Tg’, Crystal Transitions, Teu, Softening)
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Identifies viscosity changes within the frozen structure
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Optimised for frozen state analysis
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Typical analysis time: 1 hour
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Alarms and liquid nitrogen precision allow greater control over analysis
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Updated control unit and wiring design reducing benchtop footprint
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Simplified operation to increase reliability of results
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Most accurate analysis data available on the market
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Clear graph data and flexibility during post-analysis
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Simple data processing – exporting to Excel tailors the graph to the analysis
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On-site installation includes full training into operation and interpretation of results
MicroPress Quantifying Lyo Cake Robustness
Traditional methods of assessment of the physical and structural properties of a freeze-dried cake are limited to subjective, qualitative tests that do not necessarily provide evidence of robustness to transport and handling.
Our solution
Biopharma has developed a quantitative method for determining the robustness (Young’s Modulus) and strength (max stress at failure) of lyophilized cakes. The MicroPress uses a linear actuator to gently compress the cake while a load cell accurately measures the force applied. The resulting stress-strain profile captured by the integrated software is then exportable to Microsoft Excel for further interpretation and analysis.
By performing this analysis, the user can determine how the cake will behave during storage and shipment.
Key benefits of using MicroPress
• Determine key parameters for cake quality
• Easily measure physical properties
• In situ analysis – no sample prep required
• Shelf mapping
• Ensure product quality during storage
• Batch QA/QC
Freeze Drying Microscope
Open stage to add sample
Differential Scanning Calorimetry (DSC) Stage for LyoStat
Freeze Drying Microscope
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Biopharma Group
Biopharma Services and Training
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In-depth characterization of your product in terms of its key thermal event temperatures and behavior is the first step in product and process development. This information will provide the foundation for all further R&D, scale-up and QC.
Formulation Development combines in-depth product characterization with our extensive knowledge of excipients. A well-designed formulation will provide protection from the stresses of freeze drying, whilst also ensuring a thermal profile that is favorable for freeze drying.
A successful freeze drying cycle will provide reliable, safe processing in a timely and efficient manner. Biopharma’s cycle development services will tailor the freeze drying process to the requirements of your product and the capabilities of your equipment.
Dynamic Vapour Sorption (DVS) is a gravimetric technique that measures how quickly a sample absorbs a solvent vapour, and how much solvent in total is absorbed. Our testing can give useful information about the effects of specific humidity levels on a material.
Process Optimization and Scale-Up
Seemingly minor changes in formulation, container or equipment can affect the efficiency of a lyophilization cycle and efficacy of the dried product. This service will ensure your processes are optimized for your requirements at laboratory or production scale.
We offer a small-scale lyophilization service to provide process testing, production flexibility, or fall-back capabilities. This can be used to meet your ad hoc or long-term regular production requirements.
Biopharma Technology has significant experience in collaboration with academia and industry and is always keen to explore new relationships which will progress the field of lyophilization.
Historically, many freeze drying cycles have been developed by trial-and-error. Lyophilization Process Review is a quick and simple service that will check whether your process is suitable for your product.
We provide a range of options for training in freeze drying technology, including both regularly scheduled and customized courses.
Lyophilization Consulting Services
Regular courses and Special In-house classes available
Lyophilization Consulting Services
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