Biopharma Technology
Biopharma Technology is the answer to all of your lyophilization questions.
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Biopharma Technology
Analytical Instruments
Lyostat Freeze Drying Microscope
Lyotherm Frozen State Analysis
Differential Scanning Calorimetry (DSC) Stage
Biopharma has developed two advanced analytical instruments – the Lyostat freeze-drying microscope and the Lyotherm DTA and impedance analyser – to provide exactly these answers. During the past decade, both instruments have been improved and updated to give the current instruments which are described below.
The Lyostat identifies critical formulation parameters including collapse temperature (Tc), eutectic melting temperature (Teu), crystallisation phenomena, the potential for skin/crust formation, and the effects of annealing on ice crystal growth, solute structure and critical temperature. The Lyostat freeze drying microscope is PC controlled to provide sophisticated image and data capture along with analysis functions, which allows the user to determine the failure point of their formulations.
The Lyotherm 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.
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Biopharma Analytical Instruments
Biopharma Technology
DSC Stage option for Lyostat
Differential Scanning Calorimetry (DSC)
Biopharma Technology
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.
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