Provide feedback and/or suggested changes to operational procedures. Identify and elevate processing issues (large and small) and implement solutions. * Support the Process Development team in transfer of new projects and scale-up of processes into GMP manufacturing. QUALIFICATIONS: Continuous Improvement : 1 5 % of TIME Perform environmental monitoring activities during aseptic processing. Work with Facilities/IT to maintain calibration, preventative maintenance, and operation requirements of manufacturing equipment. Contribute to and a uthor and complete Master Batch Records under cGMP & tech transfer documentation and use SOPs/forms and MBRs for processes and manufacturing steps to meet both operational and compliance requirements. RESPONSIBILITIES : Solve operational tasks in the operation of purification processes, including column packing, UNICORN method writing, filtration assembly design, and aseptic filling via manual and automated processes. This is not your “everyday” manufacturing opportunity - in this new and important role, your hands-on operation experience in cGMP biologic manufacturing will help facilitate 4D’s road to a pivotal point in its history – a fully integrated biopharmaceutical company with cGMP clinical manufacturing and future commercial facility. Opportunities to expand to other indications and modalities within genetic medicine.Initial product safety and efficacy data substantiates the value of our platforms.Robust technology and IP foundation, including our TVE and manufacturing platforms.Five candidate products in the clinic and two declared pre-clinical programs.Demonstrated ability to move rapidly from idea to IND.Fully integrated clinical-phase company with internal manufacturing.This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT. In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency. We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.ĤDMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. At 4D Molecular Therapeutics Emeryville, California At 4D Molecular Therapeutics, Inc.
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