\n GMP, GLP & GCP compliance\n
\n\n We audit facilities manufacturing drugs; carrying out\n in-vitro PK / PD studies (as well as regular laboratory\n testing); and clinical testing of the drugs (phase 1 to\n phase 4) as per USFDA & Health Canada guidelines. We\n also work as internal auditors to help the industries set-up\n as per regulatory guidelines so that they don’t have any\n trouble going through the external audits.\n
\n \n\n Auditing and Validation of facilities, equipment and methods\n
\n\n These services can be provided for facilities, equipment as\n well as methods as per the required regulatory norms. The\n validation services can be both retrospective as well as\n prospective. Our consultants are well versed in all of\n these.\n
\n \nEducation
\n\n Our consultants have a lot of experience with industry as\n well as academia. Therefore, they are ideal for providing\n education in the fields of manufacturing as well as\n pharmaceutical / medical devices regulation.\n
\n \n\n Regulatory Submissions to Health Canada and FDA\n
\n\n Submitting the documents to regulatory agencies for approval\n of manufacturing, testing or clinical trails is very\n crucial. The main reasons are the volume of the documents,\n the formatting and the content as per regulatory guidelines.\n We are experienced in doing that and would definitely\n involve experts who will not only help you put together\n those documents but will make sure that all requirements are\n met.\n
\n \n\n Documentation (SOP Preparation etc.)\n
\n\n We have experts in this field and ensure that our services\n will be up to the mark and documents will definitely meet\n the required standards.\n
\n \nTraining
\n\n We can also provide training in the fields of setting up the\n manufacturing plant, manufacturing, testing as well as\n clinical trials. Very soon we are going to start some\n training programs in this area.\n
\n \n\n Compliance with ISO 9000, ISO 14000 and ISO 13485 guidelines\n
\n\n International Organization for Standards based in Geneva,\n Switzerland is the body that has published more than 21000\n standards. The above said standards i.e. ISO 9000, ISO 14000\n & ISO 13485 are more important for the quality\n management, environment systems of pharmaceutical and\n medical device companies. We can do external as well as\n internal auditing for your company so that it can get one of\n these certificates and be compliant.\n
\n \nMedical Devices Regulation
\n\n We can implement as well audit ISO 13485 standards for a\n medical device manufacturer. All the regulatory norms for\n the manufacturing as well as testing of the medical device\n can be implemented and audited for compliance.\n
\n \nNavneet Sharma
\n\n Ph.D. & MBA\n
\n President & CEO\n
\n \n He is an industry professional with many years of experience in\n the development of processes for production of semi-synthetic\n antibiotics and immobilized industrial enzymes. He has spent\n many years doing biochemical research as well, resulting in many\n publications and processes.\n
\n\n Presently, he is an Adjunct Faculty at University of Calgary but\n has worked for more than 10 years with DSM Anti-Infectives,\n Max-Gb as well as Max India in the roles of Process / Product\n Development, Regulatory, QA as well as R&D. He has a good\n knowledge base in the fields of Biochemistry & Molecular\n Biology as well as Microbial Fermentation.\n
\n\n He has helped many organizations to get approval with respect to\n different regulatory norms. He has also worked in the field of\n Auditing and Validation of facilities, methods and equipments.\n
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Board of Advisors
\nDr. Derrick Rancourt
\n\n He is a Professor in the Depts. of Oncology, Biochemistry &\n Molecular Biology and Medical Genetics, University of Calgary.\n He received his BSc and PhD in Biochemistry from the University\n of Guelph and Queens University respectively and postdoc’d in\n the laboratory of Nobel Laureate Dr. Mario Capecchi.\n
\n\n He is the Director of the University of Calgary’s Centre for\n Mouse Genomics, which specializes in the generation of\n transgenic and knockout mice. His research program revolves\n around the derivation, expansion, differentiation and genetic\n manipulation of mouse and human pluripotent stem cells,\n including embryonic stem cells and induced pluripotent stem\n cells.\n
\n\n Over the past several years he has been developing bioprocesses\n for generating bone and cartilage tissue from stem cells for\n transplantation. An important feature of the research is the\n development of methods for expanding and differentiating murine\n and human pluripotent stem cells in stirred suspension\n bioreactors.\n
\n\n
Dr. Allen W. Davidoff
\n\n Currently President and CEO of XORTX Pharma Corp.(2013-).\n Formerly, Chief Scientific Officer, VP Product Development and\n co-founder of Stem Cell Therapeutics Corp. (7 yrs). Prior to\n Stem Cell Therapeutics Corp., Senior Scientist and Head of\n Pharmacology at Cardiome Pharma Corp.\n
\n\n Dr. Davidoff has 14+ years of therapeutic drug development\n experience with a focus on clinical and regulatory developmental\n affairs, in the US, Canada, Germany, Denmark, Argentina and\n India. Senior management and leadership experience includes\n pharmaceutical non-clinical and clinical R&D including 2\n investigational new drug (“IND”) applications or supplemental\n IND’s, 2 phase I studies (4 multi-country), 7 phase II studies,\n and 1 NDA.\n
\n\n Dr. Davidoff led pharmacology, non-clinical development and\n clinical development of Congestive Heart Failure, Gout, Stroke,\n Traumatic Brain Injury and Multiple Sclerosis therapy programs.\n He has extensive Regulatory and Clinical experience advancing 4\n small molecule Cardiovascular drugs and 3 biologic drug based\n Stem Cell therapeutic programs from laboratory evidence through\n a variety of stages of clinical trials in 6 Countries.\n
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Dr. Rachel Syme
\n\n Dr. Syme is the Assistant Director with CIHR’s Institute of\n Cancer Research. She received her BSc (Honours) at Queen’s\n University, MSc (Medical Genetics) at the University of Calgary,\n and her PhD (Microbial Immunology) at the University of Calgary.\n She carried out post-doctoral work at the Tom Baker Cancer\n Centre focusing on dendritic cells and cellular based cancer\n vaccines. She spent a number of years as manager of the Clinical\n Trials Unit at the Tom Baker Cancer Centre prior to moving to a\n provincial position as Operations Leader of the Alberta Clinical\n Cancer Research Unit and then as Executive Director of Research\n Administration with Alberta Health Services. She currently holds\n an adjunct assistant professor position with the Department of\n Oncology at the University of Calgary. She also remains a\n coordinator and lecturer with the University’s Master of\n Biomedical Technology Program. Her present research interests\n include research recruitment and clinical trials impact and\n administration. She serves on N2’s board of Directors as well as\n a member of the Mount Royal Univeristy’s Research Ethics Board.\n
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Contact Thera Biotech
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\n Contact Thera Biotech today to schedule a time for a your\n questions and consultation!\n
\n\nThera Biotech
\n\n 192 Citadel Meadow Close NW,\n
\n Calgary, AB T3G 4T4, Canada\n
\n {\" \"}\n Email:{\" \"}\n
Protein / Enzyme Purification
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\n \n Expression & Purification of Proteins / Enzymes from\n microbial as well as mammalian Cultures\n \n
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- \n Production of\n recombinant cell cultures in shake flasks, lab fermenters or\n big production scale vessels\n \n
- \n Purification\n techniques including Gel Filtration, Ion Exchange,\n Affinity purification and covalently tagged purification\n techniques\n \n
- \n Removal of the tags\n after purification and proper folding of recombinant proteins\n \n
- \n Enzyme Assays as well\n as Identification of the proteins using Mass Spectrometry\n \n
Phage Display
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\n Proteomics including Phage display library\n
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- \n Can analyze the\n different proteases for their site of catalysis using phage\n display\n \n
- \n Can analyze the\n substrates for the proteases using phage display\n \n
- \n Can generate reliable\n antibodies against targets using phage display\n \n
Genomics
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\n \n Genomics including constructing vectors, screening of\n genomic libraries and analyses.\n \n
\n\n \n Mammalian cell culture as well as microbial cultures including\n bacteria, fungi and bacteriophages.\n \n
\nBiochemical Testing
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\n \n Can analyze the samples to determine biochemical content using\n the following techniques\n \n
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- \n HPLC & FPLC\n \n
- \n Mass Spectrometry\n \n
- \n DNA & Protein\n Electrophoresis\n \n
- \n Western Blotting\n \n
- \n Titrations (Karl\n Fisher’s)\n \n
- \n Volumetric Analysis\n \n
- \n Moisture Content\n \n
\n \n Many more methods & techniques can be used as well.\n \n
\n\n We have the capability to manufacture drugs including\n antibiotics as well as their third or fourth generation\n intermediates in an industrial scale set-up. Of course all of\n these drugs and the intermediates will be manufactured in cGMP\n certified facilities by fully trained personnel. Many enzymes\n useful for bioconversions can also be produced in fully\n compliant facilities. These enzymes can also be immobilized\n using different media components for their effective use in\n conversions. Some of the major products that we can handle are\n given below:\n
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\n The projects that we anticipate for manufacturing are based on\n fermentation. We have the technical expertise to manufacture\n antibiotics, antibodies and proteins using fermenters and\n downstream processing units including MF (micro-filtration), UF\n (ultra-filtration), RO (reverse osmosis), Chromatography,\n Crystallization and Drying. We can definitely include Recovery\n Units along side to limit wastage and recover more organics.\n Some of the examples of our bio-manufacturing are as given\n below:\n
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