Biopharm Services

Chesham, United Kingdom

Biopharm Services

Chesham, United Kingdom

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Grant
Agency: GTR | Branch: EPSRC | Program: | Phase: Research Grant | Award Amount: 5.84M | Year: 2011

In the 1980s it began to be possible to produce potentially unlimited quantities of human proteins by placing the gene defining them in a simple organism such as yeast. From this grew a new kind of medicine capable of treating conditions such as severe arthritis, haemophilia, growth deficiency, and some cancers that previously had no satisfactory treatments. As well as having great clinical value the resulting technology has become the basis of a new and fastest growing part of the pharmaceutical industry, described as biopharmaceuticals. Because the molecules involved are proteins, they are orders of magnitude larger and more complex than conventional drugs such as aspirin and their processing is much more demanding. They are also so complex that they cannot in general be characterised with precision except in relation to the methods by which they are made. That means the capacity to precisely define such processes is critical to clinical safety and commercial success. Full scale trials of the processes are so costly they can only be conducted once clinical promise is established but, given the number of factors governing processing of even first generation products, there have often been hold-ups so extensive as to delay availability to patients. UCL has pioneered micro scale methods that are sufficiently good at predicting efficient conditions for large scale performance that far fewer and better focussed large scale trials suffice. That resolves part of the problem but an even greater challenge is now emerging. The early biopharmaceuticals were in general the easiest ones to produce. The final scales were also relatively modest. Now, the next generation of biopharmaceuticals are more complex materials and with rising demand the scales are far larger so that processes push the boundaries of the possible. The combined complexity of the product and the process with so many variables to consider means that the managers need better systematic means of supporting their decisions. Already the cost of developing a single biopharmaceutical can exceed 0.7 billion and take 10 years. With more advanced biopharmaceuticals these figures tend to rise and yet the worlds governments are facing a healthcare cost crisis with more older people. They therefore exert pressure on companies to reduce prices. Because the public wishes to have medicines that do not pose risks, regulations become ever more stringent so they are a major factor in defining the bioprocess. This also adds to the need for managers to have sector-specific decisional-support aids well grounded in the detailed engineering of the processes. Finally, it is now possible to apply molecular engineering to proteins and vaccines to enhance their therapeutic properties but this can also cause serious bioprocessing problems. The research vision developed with detailed input from UK industry experts will apply these methods as the foundation for another step change whereby much faster and lower cost information can be gathered and integrated with advanced decisional techniques to give managers a better foundation on which to base their policies. The academic team from leading UK universities provides the necessary continuum of skills needed to assess the ease of manufacture of novel drugs, the costs of processing and of delivery to patients. We will work with companies to test the outcomes to ensure they are well proven prior to use on new biopharmaceuticals. This will cut costs so that all the patients who might benefit can receive them and at the earliest possible date achieved within the severely restricted budgets now available to the NHS.


Lim J.,Biopharm Services | Sinclair A.,Biopharm Services | Shevitz J.,Refine Technology | Carter J.B.,Refine Technology
BioPharm International | Year: 2011

Fed-batch and perfusion culture are the two dominant modes of operation for mammalian-cell-culture based processes, especially for the production of glycosylated proteins required in large amounts. This article provides an economic comparison for the production of a typical glycosylated protein using the fed-batch, concentrated fed-batch (CFB), and concentrated perfusion (CP) technologies. The CFB and CP processes are based on the ATF System, a platform technology developed by Refine Technology for biologics production.


Walther J.,Sanofi S.A. | Godawat R.,Sanofi S.A. | Hwang C.,Sanofi S.A. | Abe Y.,Biopharm Services | And 2 more authors.
Journal of Biotechnology | Year: 2015

The biotechnology industry primarily uses batch technologies to manufacture recombinant proteins. The natural evolution of other industries has shown that transitioning from batch to continuous processing can yield significant benefits. A quantitative understanding of these benefits is critical to guide the implementation of continuous processing. In this manuscript, we use process economic modeling and Monte Carlo simulations to evaluate an integrated continuous biomanufacturing (ICB) platform and conduct risk-based valuation to generate a probabilistic range of net-present values (NPVs). For a specific ten-year product portfolio, the ICB platform reduces average cost by 55% compared to conventional batch processing, considering both capital and operating expenses. The model predicts that these savings can further increase by an additional 25% in situations with higher-than-expected product demand showing the upward potential of the ICB platform. The ICB platform achieves these savings and corresponding flexibility mainly due to process intensification in both upstream and downstream unit operations. This study demonstrates the promise of continuous bioprocessing while also establishing a novel framework to quantify financial benefits of other platform process technologies. © 2015 Elsevier B.V.


Sinclair A.,Biopharm Services | Monge M.,Biopharm Services
BioPharm International | Year: 2010

As part of the Sanofi Pasteur Knowledge & Innovat ion for Technology Excel lence (KITE) initiative, we have been able to demonstrate the feasibi l ity of large-scale Vero cell culture in disposable bioreactors up to the 500-L scale. This included successful integration of the disposable process from seed to large-scale cell expansion and infection, including cell thawing and expansion directly in the disposable Nucleo 20 (a closed system for sampling, decontamination, and waste elimination) up to a 500-L working volume. Good virus yield and productivity were obtained in 20-, 200-, and 500-L scale disposable bioreactors. By using a validated BioSolve process modeling platform, we were able to identify where significant time and money savings could be achieved by implementing disposables. Sanofi intends to continue the scale-up program and will move to disposable industrial integration wherever is posables demonstrate benefits in line with the criteria defined in the KITE program. In the future, based on KITE program criteria, Sanofi Pasteur will in some cases consider hybrid processes involving a mixture of stainless steel and disposable technologies to solve ergonomic and large equipment decontamination issues.


PubMed | Biopharm Services and Sanofi S.A.
Type: | Journal: Journal of biotechnology | Year: 2015

The biotechnology industry primarily uses batch technologies to manufacture recombinant proteins. The natural evolution of other industries has shown that transitioning from batch to continuous processing can yield significant benefits. A quantitative understanding of these benefits is critical to guide the implementation of continuous processing. In this manuscript, we use process economic modeling and Monte Carlo simulations to evaluate an integrated continuous biomanufacturing (ICB) platform and conduct risk-based valuation to generate a probabilistic range of net-present values (NPVs). For a specific ten-year product portfolio, the ICB platform reduces average cost by 55% compared to conventional batch processing, considering both capital and operating expenses. The model predicts that these savings can further increase by an additional 25% in situations with higher-than-expected product demand showing the upward potential of the ICB platform. The ICB platform achieves these savings and corresponding flexibility mainly due to process intensification in both upstream and downstream unit operations. This study demonstrates the promise of continuous bioprocessing while also establishing a novel framework to quantify financial benefits of other platform process technologies.

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