Sign New Jersey Work Order Mobile

Document type sign work order new jersey mobile

hello welcome to the capabilities walkthrough of biocentric New Jersey innovation Institute's premier cell and gene therapy Development Center biocentric is a full-service lab to clinic development partner that supports process development and GMP clinical production biocentric operates in four areas of the cell and gene therapy development cycle process development application development workforce development training and clinical cGMP production biocentric state-of-the-art development capabilities coupled with a flexible and collaborative approach makes the center unique the center employs highly skilled technical staff with extensive industry experience delivering the highest quality product efficiently and cost-effectively our partners retain all intellectual property generated during interactions with biocentric biocentric is conveniently located within the major biotechnology hub from massachusetts to maryland the development center houses two ISO 7c GMP suites designed for cell and gene therapy viral vector and vaccine production bsl-2 rated pilot plant with supporting infrastructure as well as quality control and process development capabilities for the development of advanced therapeutics our clinical manufacturing facility has been designed to adhere to all FDA standards to controlled access is o7c GMP suites allow for the processing of multiple patient samples while maintaining confidentiality quality and efficiency separate air handling units ensure product sterility the center operates under strict quality guidelines under constant monitoring of the latest manufacturing execution system technologies allowing for product tracking and remote data collection throughout the entire production process these factors ensure the packaged product is of the highest quality and meets FDA guidelines while minimizing the bane to vein time biocentric extensive cell therapy suite can support up to 120 patients annually for the most sought after cell types including car t car em natural killer pluripotent stem cells mesenchymal stem cells and dendritic cells and others our expert team is experienced in both pathologists and allogeneic cell therapy manufacturing and viral vector production enabling the design of custom transduction vectors for your process we use a variety of industry-leading biotechnology platforms including site Eva flex Factory and Milton II clinics allowing for agile production strategies to fit any process our manufacturing execution system and quality management systems allow for automated bang devayne product tracking and enhances the handling of logistical operations allowing our team to focus on cost effective and time efficient production our gene therapy suite supports the production of a large viral vector portfolio including lentivirus AV a AV retrovirus unko lytic virus and herpes viral vectors our single-use production methods support up to 200 liters of viral vector therapeutics and after 24 runs per year all while maintaining the highest quality standards production purification and formulation are performed in-house with single-use equipment to eliminate muscat contamination the gene therapy suite is outfitted with the latest upstream and downstream production technologies as well as manufacturing and quality management systems to track the products and gather data throughout the manufacturing process in addition to our in-house methods we offer custom component sourcing services from customer preferred vendors in order to meet the specifications of your gene therapy product our close partnerships with leading biotechnology companies allow us to use the latest cell therapy and viral vector manufacturing Suites these systems combined with our industry analytical testing services ensure the patient receives a product that exceeds industry standards take a moment to get familiarized with our technology platforms quality is the highest priority a select list of quality control and analytical systems consists of in process testing stability and comparability studies verification and product validation our methods include identity potency purity endotoxin sterility and bioburden testing our quality control and analysis procedures are performed in-house and meet all FDA criteria and see GMP quality guidelines although extensive these methods ensure your product reaches the patient quickly without sacrificing quality our process Development Center is a fully equipped bsl-2 facility offering process and product development in cell therapy upstream and downstream viral vector production and analytical systems the facility has suspension and adherent cell culture capability as well as analytical support for process and product monitoring what is unique about our process development approach here at biocentric is that we encourage collaboration and allow clients to access the development of their process and product this flexible approach allows us to design a customized process that is right for our client and their product biocentric process Development Center supports the development of a variety of cell and gene products with a wide spectrum of equipment our team can help move your product from bench to batch scale with a customized approach that is optimized specifically for you we do not retain any intellectual property as we completely scale up the operations and technology of your process the process Development Center itself is a fully equipped bsl-2 facility with upstream and downstream capabilities in both cell and gene therapy product testing and optimization our cell culture capabilities range from suspension to adherent based samples the process Development Center houses the latest in equipment and biotechnology systems allowing for our scientists to utilize the systems of tomorrow while helping technology companies are fine their products for mainstream usage in addition to our team working in the Development Center we encourage our partners to access the facility in a collaborative effort to learn the operations of the latest biotechnology systems develop a fully customized process and provide the testing necessary to move your product to clinical production scale biocentric has a broad mission to support cell and gene therapy development and that includes training and cultivating the next generation workforce we offer a variety of Workforce Development Services here at biocentric our programs include hands-on training classroom instruction virtual instruction and customized hybrid services hands-on training is hosted in-house and is led by our team as well as our industry expert partners and cell and gene therapy special attention is given to emphasize not only the technical aspects of production but also operational excellence to meet industry standards and regulations we have partnered with academia to create the first professional Masters of Science degree in cell and gene therapy offered at a university as well as professional certification programs in the technical and operational aspects of cell and gene therapy the instructors for these programs are available for custom modules to help with technical and regulatory transition from traditional Pharma to these advanced therapies if you require a more flexible training solution we offer custom hybrid sessions that offer all facets of our Workforce development's programs and can be hosted in your facility on your equipment biocentric Workforce Development Center provides space to support all facets of workforce training the facility hosts lecture sessions from industry leaders breakout sessions with our moderators facilitating discussion as well as a customizable hands-on training lab the hands-on training lab is a fully customizable facility to meet the needs of the production that will be done in your facility using actual industry standard equipment we recreate a production process and our personnel provide the guidance necessary to transition all aspects of manufacturing quality control and workflow from current state to future State for implementation in your facility our example is outlining Carty manufacturing here we would walk the client through gowning up regulations and the logistics of receiving a new sample we would demonstrate the steps necessary and sample separation enrichment activation expansion and media preparation harvesting fill finish and cryopreservation for shipment to the patient in addition we demonstrate the necessary steps unique to a CE GMP facility and comply with all FDA regulations as well as the technical aspects of the latest manufacturing execution and quality control systems here at biocentric we provide many advantages to our partners for the bio format industry we provide access to state-of-the-art cell and gene therapy manufacturing and process development services our flexible and custom approach encourages collaboration and our clients work alongside our team to perfect a process that works for them we provide cost-effective solutions for development testing and product validation all while allowing our clients to retain all intellectual property for technology and equipment developers we provide the opportunity to showcase and beta test your technologies in our pilot plants we provide hands-on training to our clients on your technology which would accelerate the adoption of your cutting-edge equipment our partnerships with regulatory agencies academia and established clients provide opportunities for collaboration and refinement of your equipment to become an industry leader both biotechnology and biopharma companies that partner with us have access to workforce training programs as well as member exclusive access stat workshops and networking events in new technologies and novel manufacturing processes our core team has nearly 90 years of combined experience in the biopharma industry from scientists up to management in addition to our skilled team we have experienced consultants to assist and customize highly specialized processes and products we are constantly growing our team with a number of new experts joining biocentric the diverse and accomplished executives on our advisory committee come from a variety of backgrounds including the bio pharma industry regulatory agencies and biotechnology innovators they provide valuable guidance on strategic direction operational excellence and positioning of biocentric thank you for taking the time to learn about us here at biocentric we look forward to exploring partnering opportunities with and discovering how we can help advance your next generation therapeutics and technologies from the lab to the clinic please visit us at www.fortuigence.com