Biophysical Toolkit®
Our specifically designed range of Biophysical techniques that give you the ability to fully characterise your protein.
Is comparability an issue?
Thorough characterisation and maintenance of the higher order structure of a protein is critical for its development and continued success as a pharmaceutical product.
Yet it is problematic, time consuming and expensive for manufacturers to establish a thorough insight into protein structure. Widely available, routine biochemical and potency assay approaches can only take you so far - they only provide an inference of secondary and tertiary structure based on biological activity.
What is really needed is analysis that can provide a fuller characterisation of structure, and correlation with function and behaviour during development, processing, storage and delivery.
Avacta's Biophysical toolkit® does just that. It complements routine biochemical approaches with a suite of validated biophysical techniques, extensive instrumentation and detailed interpretati
on of data. As a result, Avacta can create a better picture of your protein's structure and behaviour. This knowledge can then be translated into improvements at every stage of development and, as such, the Biophysical toolkit® should play an integral role in developing any protein therapeutic.
Users of the Biophysical toolkit® enjoy:
- Improved candidate selection
- Reduced candidate attrition
- Improved and rationally optimised process designs
- Improved formulation design
- Better understanding and problem solving through the development pipeline
Scientific benefits of the Biophysical Toolkit:
- Highly concentrated solutions can be analysed. So, without the need for dilution, analysis is provided at concentrations close to clinical doses and is more representative of "real world" situations.
- In many cases the techniques are non-destructive so, in principal, multiple measurements may be made from the same sample, reducing the volume of material needed.
- Analysis is generally non-perturbing and does not affect the sample during the measurement process. As a result, there is a greater chance of detecting aggregates, therefore forewarning manufacturers of any potential immunogenic and processing concerns.
- The sampling conditions are representative of the "real" environment experienced by a protein therapeutic and results better demonstrate the effects of molecular interaction.
- Small sample sizes, down to microlitres, can easily be examined. Consequently, the Biophysical toolkit® is particularly useful in the very early stages of developmen
t where the cost of producing clinical trial grade samples prohibits extensive analysis.
- Extensive characterisation and better understanding of your protein will strengthen your case when dealing with the regulatory authorities.
Business benefits of the Biophysical Toolkit:
- It's quicker - Avacta clients see results in days rather than the weeks commonly associated with classic protein chemistry analysis techniques.
- It's cheaper - not only are sample sizes reduced, but the actual costs of analysis compare very favourably with other techniques. Moreover, concerns about comparability, which can require a full range of analysis including biopotency, toxicology and clinical trial data, could simply be removed by use of the Biophysical toolkit®.
- It's easier - Avacta carry out the complete analysis from designing and defining validated experimental protocols through to sample testing, data interpretation and reporting.
- It's more accurate - operated correctly, physical characterisation techniques, such as those used in the Biophysical toolkit®, are generally more accurate and less variable than biological and, in many cases, chemical assays.
Applications
With better characterisation comes greater understanding, and with greater understanding comes the ability to select leads more reliably, guide products through the development cycle and eliminate processing and formulation problems with ease.
Clients generally use the Biophysical toolkit® in two ways; to characterise molecules during early stage development and formulation studies, and benchmark structures for reference during the manufacturing process.
Applications include:
- Native molecule characterisation in order to establish a benchmark reference of a product.
- Understanding the effects of processes and process change on a protein's structure and stability, with a view to alleviating any undesirable effects.
- Assessing possible contamination issues, such as assessing the effects of solvents on protein conformation, to ensuring no detrimental effects to the therapeutic properties of the molecule.
- Investigations of aggregation to avoid potential immunogenic and processing concerns.
- Formulation development comparability studies to isolate the formulation that best serves your needs - without affecting the structure of your therapeutic.
- Manufacturing sit e change comparability studies to ensure protein structures remain consistent and within regulatory limits.
- Development of structure/function relationships to reduce dependence on highly variable biological potency assays.
- Any form
of comparability study where changes in higher order structure are of importance
Techniques in the Toolkit
- Near infra-red Raman spectroscopy
- Fourier transform infra-red spectroscopy
- UV resonance Raman spectroscopy
- UV absorpti o n spectroscopy
- Fluorescence excitation and emission spectroscopy
- Near and far UV circular dichroism spectroscopy
- Light scattering
- Analytical ultracentifugation (velocity and equilibrium)
- Differential scanning calorimetry
- Equilibrium unfolding curves
- Folding kinetics measurements
- Time Resolved fluorescence Anisotropy Measurements
- Isothermal Titration Calorimetry
- Time Correlated Single Photon Counting
Avacta will advise on,
and carry out, the most suitable techniques for your specific requirements.
It is unprecedented to find this range of physical analysis techniques, and the experts that understand them, in one organisation. These experts not only know the techniques and instruments, but, more importantly, understand that you need more than just raw data. Avacta will provide you with a new, deeper and more accurate insight into your proteins' structure and behaviour.
Better characterisation and the regulatory bodies
All the techniques have been developed with ICH Q2(R1) and Q6B guidelines in mind, and with the FDA currently championing fuller characterisation of therapeutic protein structures, it is safe to assume such techniques, in the future, will be required for all regulatory work. Get ahead of the regulators, and your competitors, by making complete biophysical characterisation of your proteins routine in your company.
Commitment to quality
Avacta is ISO 9001:2000 registered and is committed to the highest scientific standards. Thoroughness, accuracy and integrity are the foundations of all its research and analytical work and are second nature to its highly qualified staff
Avacta are active members of the Special Interest Group on Formulaic and Analytical Development with BioProcess UK and are committed to the development of biophysical analysis of protein therapeutics as a powerful new tool for the Biopharmaceutical industry.
Register and download our free biophysical techniques guides.
For more information on the services we can offer you, please contact us on +44 (0) 870 835 4367 or