Adalimumab
Adalimumab, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis. In rheumatoid arthritis, adalimumab has a response rate similar to methotrexate, and in combination, it nearly doubles the response rate of methotrexate alone.Adalimumab
Trastuzumab
Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer. Specifically it is used for breast cancer that is HER2 receptor positive. It may be used by itself or together with other chemotherapy medication. Trastuzumab is given by slow injection into a vein and injection just under the skin. Trastuzumab was approved for medical use in the United States in 1998. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. The wholesale price in the developing world is between 1,800 and 1,955 USD per 440 mg vial. In the United Kingdom a 150 mg vial costs the NHS 407.00 pounds.Trastuzumab
Bevacizumab
Bevacizumab, sold under the trade name Avastin, is medication used to treat a number of types of cancers and a specific eye disease. For cancer it is given by slow injection into a vein and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. For age-related macular degeneration it is given by injection into the eye. Bevacizumab is in the angiogenesis inhibitor and monoclonal antibody families of medication. It works by slowing the growth of new blood vessels. Bevacizumab was approved for medical use in the United States in 2004. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.Bevacizumab
Rituximab
Rituximab, sold under the brand name Rituxan among others, is a medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, idiopathic thrombocytopenic purpura, pemphigus vulgaris and myasthenia gravis. It is given by slow injection into a vein. Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab was approved for medical use in 1997. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. The wholesale price in the developing world as of 2014 is US$148–496 per 100 mg.Rituximab
Alemutuzmab
Alemtuzumab is a drug used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma under the trade names Campath, MabCampath and Campath-1H, and in the treatment of multiple sclerosis as Lemtrada. It is also used in some conditioning regimens for bone marrow transplantation, kidney transplantation and islet cell transplantation. It is a monoclonal antibody that binds to CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived.Alemutuzmab
People.
Luc-Alain Savoy
Chairman and Founder
/ PhD.
Dr Savoy is co-founder and chairman of BioXpress Therapeutics SA. Previously, he co-founded in 1991 M-Scan SA, a contract research organization specializing in high level of bioproducts characterization, prior to selling it to SGS. Luc-Alain pioneered physicochemical characterization using high end mass spectrometry methodologies, which have become worldwide standards for the analysis of complex biologic products. He is currently Global Head of Biologics, at SGS Life Sciences.
Alexandra Richardson
Board member
/ PhD.
Dr. Richardson is a Director at BioXpress. She currently heads business development for Clayton Biotechnologies, where her work in project management and business development has contributed to the launch of ten products on the market and a rich clinical pipeline including several gene and cell therapy clinical candidates. In parallel, Alexandra founded ARBbiotech, Sàrl, a Swiss company that offers business development and strategy consultancy in life sciences with a focus on licensing early stage biotech assets. She was previously a Licensing Officer at Unitec, the technology transfer office for the University of Geneva and University Hospitals of Geneva where she helped build its life science business.
Igor Fisch
Founder
/ PhD.
Dr. Fisch, an accomplished protein chemist and molecular biologist, is a founder of and advisor for BioXpress Therapeutics. In 2001, he co-founded Selexis SA, a world-class leader in mammalian cell line development. Through Dr. Fisch’s vision and the work of scientists at Selexis, Selexis’ SUREtechnology Platform™ enables the production of novel and sophisticated proteins such as Fc-fusions, bi- and tri-specifics and new scaffolds, among others. To date, six marketed products and nearly 130 clinical programs, including seven Phase 3 programs, were developed with Selexis’ SUREtechnology. BioProcess International named him the winner of the 2016 “Excellence in Leadership Award.” This honor was bestowed to Dr. Fisch as an outstanding leader who defines excellence and who has enabled more effective, less expensive biotherapeutic development and manufacturing. Under Dr. Fisch’s leadership, Selexis has been named a “Best Places to Work in Switzerland” for two consecutive years (2018 and 2019).
Cori Gorman
Board member and Founder
/ PhD, MBA
Dr. Gorman is a co-founder of BioXpress. She currently serves as a Board member and brings over 30 years experience in the biotechnology industry, including six years as CEO/Chairman of BioXpress. She is currently Vice President of Precision Medicine and Manufacturing at Agenus, where she leads the effort in developing individualized cancer vaccines. She has helped early-stage biotechnology companies raise more than $80 million and has closed more than 35 partnerships. During her tenure at Genentech, Dr. Gorman helped develop several marketed products including Kogenate®, Activase®, Herceptin®, Xolair®, Raptiva®, Avastin® and Perjeta®. The total sales of these marketed therapeutics exceed $15 billion. Her team work for the development of Herceptin® was recognized with the Lasker Award. She is an inventor on nine issued patents in the fields of gene expression and delivery and gene therapy Her scientific work has received over 21,000 citations.
Devra Nevin
Project Leader
/ PhD.
A Molecular Biologist and Biochemistry Postgraduate with a strong scientific background developed over 25 years plus experience within the biotech and pharmaceutical industry, Dr. Nevin joined BioXpress in 2014. Debra has a proven manufacturing development expertise for both biological and chemical entities, with involvement in a number of licensed products and is experienced across all phases of pharmaceutical manufacturing drug development from early phase, non-clinical research through to Phase III leading to commercialization. She has particular expertise in cell line development from vector construction to lead candidate selection. Experienced in EU, Canadian and Indian regulatory processes leading up to NDA and MAA license applications.
Gerrit Hagens
Board Member
/ PhD, MBA
Dr. Hagens is a Director at BioXpress and a Professor at the University of Applied Sciences HES-SO, Sion, Switzerland. Gerrit Hagens gained a strong manufacturing process development experience during the last 20 years in the industry. Before joining BioXpress where he heads project management since 2010, he was member of Serono’s core team managing the Neurology Business Unit. He then took over executive roles at ExcellGene and RiboVax as COO and President and helped developing manufacturing processes for biologics. Gerrit is also co-founder of NatiMab, a company specialized in the development of antibody-based therapies and diagnostics.
Pipeline.
BXT 2318
Trastuzumab
Our studies comparing BXT 2318 to several originator batches from the EU and the US showed highest biosimilarity from a physico-chemical standpoint and in bioassays. GMP-batches of BXT 2318 will be available in 2019.
Full CMC documentation on cell line and manufacturing process are available upon request
BXT 2316
Bevacizumab
- Intact mass analyses by MS, SDS-PAGE
- Peptide mapping
- Amino acid sequencing
- glycan analysis
- Charge heterogeneity by cIEF and CEX
- Purity by SEC
- Potency assays (binding to VEGF and HUVEC-based bioassays)
Full CMC documentation on cell line and manufacturing process are available upon request
BXT 2336
Rituximab
Full CMC documentation on cell line is available upon request.
BXT 2922
Adalimumab
- Intact mass analyses (reduced and non-reduced) by MS, SDS-PAGE
- Peptide mapping
- Amino acid sequencing
- N- and C-terminal sequencing
- glycan analysis
- Charge heterogeneity by cIEF and CEX
- UV-circular dichroism and fluorescent spectroscopy
- Purity by SEC
- Bioassay including ADCC- and TNF-neutralization assays
Full CMC documentation on cell line and manufacturing process are available upon request
BXT 1523
Alemtuzumab
- Glycan analysis
- Intact mass analyses (reduced and non-reduced) by MS, SDS-PAGE
- Charge heterogeneity by cIEF and CEX
- Purity by SEC
Partners.
Consulting partner: Geneva, Switzerland
https://www.arbbiotech.com
Manufacturing partner: Monthey, Switzerland
https://swissbiotechcenter.com
Research partner: Slon, Switzerland
https://www.hes-so.ch
Cell-line partner: Geneva, Switzerland
https://selexis.com
Analytics partner: Geneva, Switzerland
https://www.sgs.com
Consulting partner: Geneva, Switzerland
http://www.octavebiotech.com/About.
Biopharmaceuticals have revolutionized modern medicine and given new hope for those diagnosed with cancer and other devastating chronic diseases. Monoclonal antibodies remain the most advanced and effective therapeutics for such diseases to date. Biosimilars promise to make these cutting-edge drugs more accessible, offering to prolong and improve the lives of even a greater number of patients across the globe.
BioXpress was founded in Geneva by the industry leaders in cell-line development and analytical characterization and has built a team of experts in the development of biopharmaceuticals and biosimilars, their manufacturing, characterization, clinical and regulatory development. The team has developed 12 originator biologics, seven of which are monoclonal antibodies, including Herceptin, Rituximab, Avastin, Xolair, Panitumumab, Denosumab, Humira.
Our long partnership with Selexis ensures highest standards in cell-line development, coupled with a collaboration with SGS for analytics, and priority access to laboratories and a CMO in Switzerland for optimal process development and GMP manufacturing so that the development of our biosimilars can be managed in a cost-effective and streamlined process.
The team is focused on the development of high quality biosimilar monoclonal antibodies while maintaining low development costs. While continuing to focus on the development or our pipeline, we engage in partnerships through licensing, collaborations and also can help you with the R&D management of your in-house biosimilar programs.
