Bristol myers squibb largescale cell culture manufacturing. Core facilities cell culture equipment biological safety cabinets biological safety cabinets nuaire biological safety cabinets providing personnel, product andor environmental protection when looking to obtain optimum control over product quality while reducing the potential for exposure. This new design provides improved performance and scalability to larger volumes. Research core facilities at university of colorado anschutz.
Facility layout designing and implementation is influenced by various factors. Lab space planning and facilities design chi solutions, inc. Computeraided design cad tools can help you achieve such objectives. Describe some key features of effective lean design. This article throws light upon the nine applications of animal cell culture. Please note, however, that advances in technology e. The rensselaer center for stem cell research rsscr is a shareduse facility that provides stateoftheart equipment, research collaboration and training for stem cell research. Cell culture facility biosciences divisional services. Identifying techniques that are wellestablished and using cell lines that are wellcharacterized are the keys to establishing a solid foundation. At nikon bioimaging lab, nikon offers the expertise and equipment required to carry out simple to complex cell based imaging assays. Students design and perform a timeefficient inquirybased cell viability experiment using hela cells and tools that are readily available in an. Cell culture facility how is cell culture facility abbreviated. Research core facilities at university of colorado. Live cell experiments are further supported by a cell culture facility adjoining the imaging suite.
By incorporating flexible design features in initial facility construction, biotechnology companies can move from pilot to production operations and market entry in a timely and costeffective manner. Guidelines for working in the tissue culture facility. The cell culture and harvest suite is an expansion of existing clean manufacturing space, located adjacent to protein purification. Retrosynthesis software that augments your expertise the most significant challenge in organic chemistry is finding viable synthetic pathways by painstakingly navigating the complex matrix of retrosynthetic possibilities while simultaneously accounting for what has been done, what could be done, and what starting materials are available. These include labs dedicated to the culture of bacteria, animal and human cells including cancer. Software tools are becoming increasingly critical to aid in better decisionmaking for manufacturing. Present a limited case study of using lean to design a core laboratory. Whether youre in the office or on the go, youll enjoy the full set of features. Amanda capesdavis, an independent cell culture consultant and founding manager of cellbank australia, talks to contributing editor tanuja koppal, phd, about the. Compact select is the leading automated cell culture system, used in labs across commercial and academic life science. This facility is an ideation space tailored to encourage creativity and efficiency through informality and collaboration. Grant language vcu office of research and innovation.
The facility provides services to the uva research community including cell culture and storage services, transfections, baculovirus transfections, viral titering. The immunology suite in which cell and animal infections are carried out is equipped with a calibar flow cytometer with a macintosh computer loaded with cell quest software. A guidebook for the cell culture facility journal of. Cell culture facility how is cell culture facility. A dedicated image analysis workstation is available with software that includes deconvolution, particle tracking, ratiometrics, colocalization, 3d measurements, extended depth of field and other analytic and.
This webinar will discuss how process and regulations are changing the modern biotechnology facility and process design paradigm. Conducting wholeanimal imaging ultrasound and endoscopic with ultrasensitive speckle tracking. A biosafety cabinet, or laminar flow hood, is probably the most important piece of equipment for cell culture since, when operated correctly, it will provide a clean working environment for the product, whilst protecting the operator from aerosols. The project was executed in a design assist approach with integration efforts between crb and local design build contractors for completion of construction documents. Bioprocess facility design layout rules and configurations. Yet with the rise of promising new opportunities within such fields of study as. Cell culture facilities biological and soft systems. This shared resource provides services for maintaining, plating, transfection and preparation of cells for imaging and other applications. Present some examples of using lean to improve operational efficiency. There is growing interest in the use of continuous cell culture processes for the production of mammalian cell derived products.
Design and equipment for the cell culture laboratorycontents. The core also provides multidimensional image analysis image cytometry, restoration including deconvolution and visualization. Training is available for all of the imaging modalities and methods offered. Automated cell culture for high quality cells and assayready plates, suitable for smaller, medium throughput laboratories. New largescale cell culture lscc manufacturing facility. Ex vivo culture of hematopoietic and mesenchymal stem cells for tissue engineering and cell based therapies. Cell production system based on flexible modular platform. But some tenets of qbd made their way into manufacturing discussions here. The labs are fully equipped to deal with bacterial pathogens and.
With a single use based design, iso7 and iso8 clean room surfaces can be reduced by an average of 20%. Aug 11, 2017 for this reason, we have devised a laboratory module and method herein that familiarizes students with common cell culture procedures, without the use of a sterile hood or large cell culture facility. Our cell and tissue culture facility is a unique, consolidated facility providing expert maintenance of cell cultures with a high level of efficiency, competence, and safety for the research campus. Methods such as factorial design, response surface methodology, and doe provide powerful and efficient ways to optimize cultivations and other unit operations and procedures using a reduced number of experiments. Facility design considerations for mammalian cell culture. Hyperforma dynadrive singleuse bioreactor thermo fisher. When establishing a psc laboratory, identifying reliable techniques for the culture and characterization of cell lines is a critical function of the laboratory manager. Plant layout and facility software free online app. The general facility is lacking uptodate and standard business technology apart from the new laboratory space. The thermo scientific hyperforma dynadrive singleuse bioreactor s. This application note provides an overview of different filtration options in terms of. Perfusion cell culture for process development cell culture at 50. Amanda capesdavis, an independent cell culture consultant and founding manager of cellbank australia, talks to contributing editor tanuja koppal, phd, about the imperative need to establish best practices in a cell culture laboratory. Designing a flexible facility for biopharmaceuticals.
There are many factors to consider during the initial facility design phases. Developing customized software implementation for automation and analysis of new biological questions using commercial system design software. For it works, it does the job, it is a databases i. This facility was designed to accommodate the manufacture of two leadingedge cancer therapy products and provide for future production expansion. During the design of a new facility or the renovation of an existing one, the initial design discussions are paramount to the success of the entire project. Expansions and renovations to existing biological facilities and construction of new facilities provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will reduce costs and improve compliance. Performing highthroughput, wholeanimal metabolic and body composition measurements. It features ergonomic seating, comfortable ambient lighting, large flat panel displays, projection screens, and abundant access to cad and other engineering software. This chapter presents a generic case study to focus on the process and the facility in the early design phases.
An y laboratory, in which tissue culture techniques are performed, regardless of the specific purpose, must contain a number of basic facilities. Facility layout objectives, design and factors affecting. The cell culture facility comprises a gown room, a wash room. Few if any speakers at phacilitate 2020 brought it up by name, probably at least partly because most cell and gene therapy products remain in early development phases. It contains details about how to design the laboratory, and describes not only cell culture techniques but also other basic skills, such as how to load and run an autoclave. Cell culture incubators are used routinely to provide the correct growth conditions, such as temperature. Synthia organic retrosynthesis software sigmaaldrich. The facility has also been designed to produce multiple therapies for bristol myers squibb s robust and growing portfolio of approved and investigational biologic medicines. Intensified processes require a higher level of automation and often call for the. The facility supports cell culture, purification, central cleaning, bulk formulation, media and buffer prep and was designed to meet fda gmp and eu regulatory guidelines. Many facilities have a mix of old and new equipment, often running independently on custom software. Keep these in mind when considering the frequent changeover and startup in a shared facility as well as the laboriousness of operations.
Apr 22, 2005 planning, designing and building cell culture facilities present dual challenges of creating the perfect environment for current products while maintaining flexibility for contingencies typically drugs that fail testing and must be replaced, says david marks, founder and president of dme alliance, inc. Clean room volumes can be decreased by over 25% as a result of being able to lower the ceiling. To determine whether ambr 250 ht perfusion bioreactors could sustain consistent growth up to 50. Guidelines for the use of cell lines in biomedical research. Nikon bioimaging lab is a stateoftheart facility located in cambridge, massachusetts, that provides these advanced technologies to support the burgeoning regenerative medicine and biotech sector. For this reason, we have devised a laboratory module and method herein that familiarizes students with common cell culture procedures, without the use of a sterile hood or large cell culture. If you are planning to set up any functional cell culture facility, small or largescale, basic cell culture could be very useful. A class ii biosafety cabinet should be used for handling potentially hazardous materials e.
The facility must have fully integrated cell culture media and supplement manufacturing capabilities with the ability to produce complete formulations for the full range of expression systems. We have found that a nearly equal amount of time and effort is required to establish initial. Although batch and fed batch operations still predominate, an. I have used it for years since early 90s and it does the job. Clean room volumes can be decreased by over 25% as a result of being able to lower the ceiling heights that are typically required for stainless steel bioreactors, and hvac systems can be downsized by an average of 33%. The design of the facility layout should consider overall objectives set by the organization. Offering detailed guidance, they cover the steps leading up to the creation of viable therapies including host cell selection, cloning and gene amplification, bioreactor design and operation, protein purification, optimization, scaleup, and facility design. Class ii laminar flow hoods are designed for work involving bsl1, 2, and 3 materials, and they also provide an aseptic environment necessary for cell culture experiments. Is there any software to create a database of cell lines. We can expand your cell line and store multiple vials in our facility. A dedicated image analysis workstation is available with software that includes. According to these considerations, the facility design hardware as well as the management software are compelled, and the balance between hardware and software lead to the 3s. Planning, designing and building cell culture facilities present dual challenges of creating the perfect environment for current products while maintaining flexibility for contingencies typically.
The handbook is intended as a guide rather than an indepth text book of cell culture and you are encouraged to. Thermo fisher scientific has helped pioneer significant technological advances that have driven these performance gains, including improved cell lines and expression systems, cell culture media. New approaches facilitate rapid, lowcost analysis and prediction of product yield. This application note provides an overview of different filtration options in terms of microbial retention and filtration capacity and provides filter sizing recommendations for milliporesigma catalog media and additives. Cell culture technology for pharmaceutical and cellbased. Introducing mammalian cell culture and cell viability. Cell culture technology for pharmaceutical and cellbased therapies. The rsscr is open to investigators from rensselaer polytechnic institute, rpi, the albany capital region and beyond. Middough has managed a number of assignments for the aeras global tb vaccine foundation including the design of a new cell culture suite and a powder vaccine clinical launch facility. Upstream bioprocessing is evolving with improvements in cell line development and cell culture media optimization.
Multiple cell line maintenance and assayready plate production compact select. Modern cell culture systems are now producing notably higher titers while also decreasing the time from bench to production bioreactor. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The advantages of cad tools for development and economic evaluation of bioprocesses have long been recognized in the biotechnology industry 9,10. Cell cultures require a strictly controlled environment in which to grow. This core facility is a central source of tissue culture media, reagents, sterile hood space, cell banking, cell culture consultation, and specialized tissue culture cell services. Describe how to plan a design project for a clinical laboratory. Strategic outsourcing of media design and cell culture. A cell culture facility with incubators and biological safety cabinet is located onsite to support live cell imaging. Cell culture solutions cell culture applications and. These factors vary from industry to industry but influence facility layout. If you order cells from atcc, you can deposit them with the cell culture facility.