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Prior to testing any new drug on human volunteers, pre-clinical animal testing is crucial and in many instances mandatory. |
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Transgene, with its long experience since 1994, is well placed to understand the needs of the Bio-pharmaceutical drug companies and we help our clients to bring out safe and effective new drugs. We can provide an end-to-end solution, from the development of a bio-pharmaceutical drug to the stage of Phase I/II human clinical studies. |
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| Pre-clinical animal studies |
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We at Transgene have the knowledge, experience and expertise to undertake or organise pre-clinical animal studies for most Bio-pharmaceutical drugs. We employ different animal species (but not large animals) specific to the needs of the drug involved.
As part of our legal and moral obligation, we assure that animals in our study are treated in accordance with all applicable rules and with high standards of respect and compassion, as laid down by the concerned regulatory authorities. |
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| Clinical Services |
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Once early development studies are completed for the drug developed, the information learned from this process enables the company to make the next critical decision of whether to proceed further with the human clinical studies or not.
Transgene can help you, should you decide to proceed with clinical studies, to proceed smoothly in that direction. With a team of professionals, Transgene can help in designing the protocols and selection of the investigating centers. Transgene provides the necessary help in documentation, statistical analysis and preparation of study report among others until the completion of Phase I &II studies.
Transgene draws on its broad knowledge and experience, from clinical trial design and execution to the preparation and submission of data to regulatory authorities.
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At Transgene, the scientists will demonstrate each step, from the stage of cell banking and cell growth optimization in a Fermentor all the way through to the stage of protein purification, covering the various upstream and downstream processes involved. |
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| Purification of recombinant proteins |
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Sequential and appropriate downstream protein purification process is extremely important in the development of any bio-pharmaceutical drug. The ultimate goal is to achieve a high degree of purity and efficacy of the targeted recombinant protein, and this process needs to be reproducible in order for the developed drug to be commercial relevant. |
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| The scientists at Transgene have the expertise and long experience necessary to generate high-quality recombinant protein drugs. |
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| We have expertise and experience in molecular biology and will perform many other services such as: |
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Gene knockouts in yeast |
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Northern and Southern blots |
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RT-PCR analysis |
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| Please do not hesitate to contact us for your molecular biology needs. We are confident that we can provide answers to the problems you may face in this area, and that we will be able to perform the required service for you!
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