Author: Dr Andrew J. Reason- CEO and MD
“At BioPharmaSpec we are proud to operate as an extension to your own capabilities, a benefit that is recognized by the many biopharma companies that use our services.
But what exactly does this mean for you and how do we achieve this so successfully?
I believe there are three main elements to how BioPharmaSpec provides fully supported high-end characterization services which integrate seamlessly with your own:
There is obviously no substitute for high quality data from which clear conclusions can be drawn and fed back into your product development. This data not only provides you with a deep understanding of the product itself, but it allows you control over the manufacturing process.
Our many years of collective industry experience and academic development of cornerstone analytical techniques and instrumentation gives us the ability to produce clear and meaningful data though precise and focused experimental techniques.
It requires a considerable amount of experience to generate the high-quality data mentioned above, and perhaps more importantly, to put that data into context for the product being analyzed and developed.
The experience BioPharmaSpec scientists have in analysis of multiple product types is of significant benefit to our clients.
We are unrivalled in terms of the depth of experience across various elements including:
This also means that, with the growing recognition of the significance of orthogonality of data, BioPharmaSpec has the breadth of understanding to draw together the data from various analyses into a full, self-supporting analytical package.
At BioPharmaSpec we do not simply contract with our clients, perform the work and operate at arms-length. We consult with you prior to, during and after each study, and across each analytical program we may work together on. This approach provides you with the benefit of our experience in helping you to develop your product more efficiently. Thus, we work in partnership with all our clients to help address their individual analytical needs.
We will consult with you prior to any potential project to understand your requirements and we may suggest alternative or additional analyses based on the objective of the study or program.
This consultancy often includes an assessment of existing data (e.g. from analyses performed in your own laboratories) so that BioPharmaSpec can help bring the whole analytical package together. As part of this we will identify any gaps that may be present in terms of regulatory expectations and offer solutions to fill them.
In this way, your requirements are understood prior to quoting for the work, saving time in the project set-up phase.
Regular project discussions, with supplied interim data, allow immediate feedback and discussion which helps with drawing conclusions further down the line.
We have significant in-depth discussions with our clients following provision of the draft report and prior to finalisation. These discussions include overall assessments of the data, supported by the significant experience within the company, and also recommendations for further analyses we would suggest based on the data we have obtained.
We use this approach for a wide range of clients from the truly virtual to some of the largest biopharma companies in the world. Whether you require a full analytical package or some ad-hoc support to bolster your own analytical capabilities, this is what a fully supported high-end structural characterization service should look like.
“I would like to thank you for your collaboration and support, and for your shared commitment to patients. We expect our product to make an important difference and could not have achieved these regulatory approvals without your help and collaboration. We look forward to working with you on further products in the future”
“Working with you is such a great experience. You challenge our characterization plans, plug gaps and recommend additional analyses, all of which has meant that we have obtained multi-agency approval for our latest product.”
“We really appreciate the effort you made to deliver your data and report well ahead of schedule. The report looks magnificent and the data are very good news for our product.”
“Thank you very much for the final report. It was a real pleasure doing this project with you. As soon as we have future characterization and comparability work I will certainly contact you again.”
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