Thin Line Flat Design Of Viral Video Production, Digital Marketing Campaign, Internet Medium Mass Communication, Social Media Sharing. Thin line flat design of viral video production, digital marketing campaign, internet medium mass communication, social media sharing. I agree to Shutterstock's Website Terms, Privacy Policy, Licensing Terms and to receive emails that I can opt out of at any time. Thin line flat design of commercial video production studio, motion graphic and audio correction elements, lights and camera action. Thin line flat design of e-learning education process, online books for learning applied science, internet library and tutorial study. Thin line flat design of social network communication, internet media services, web community for blogging, chatting and sharing news. Line icons set with flat design elements of skill growth with reading book, learning information in video lesson, A+ grade on digital tablet, text notebook. Line icons set with flat design elements of education progress, global study, e-book learning, webinar audio course, winner pedestal, physics and math learn. Thin line flat design of social media marketing, online business solution, viral video production and promotion, digital strategy idea. Line icons with flat design elements of online education technology, people learning applied science, knowledge base growth, learn to code. Thin line flat design of computer training course, education from home using online tutorial, reading book from internet website. All plans come as a Standard license, and can be upgraded to an Enhanced license at any time. UpstreamProcessingBioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.
ManufacturingDrug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting. AnalyticalMany technologies are used to characterize biological products, manufacturing processes, and raw materials.
BusinessEven as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. We are seeking nominations for people, organizations, and technologies that innovate and lead this industry forward.
On 28 June 2011, the Food and Agriculture Organization of the United Nations declared the Rinderpest cattle plague virus to be the second troublesome virus (after smallpox) that humans have eradicated from the Earth (1).
Scale-up of cell-culture-based vaccine manufacturing was first accomplished 60 years ago in adherent-cell cultures using large glass flasks.
Selection and optimization of cell culture media is important to any production-reactor format or cell-line platform for a number of safety, process, economic, and regulatory reasons. Similar pressures exist for chemically defined and low-protein designs, but this is to a lesser degree.
Modern SFM, feed cocktails, and supplements provide for such required functions as cell nutrition, shear-force protection, cell banking, and virus replication in many cell lines and processes.
Recent product and process characterization approaches are revealing product heterogeneity in such properties as virus membrane lipid constituents and capsid protein glycomoieties induced by culture procedures and media formulations (3).
Developers should be aware of additional factors specific to cell lines, production formats, and processes when considering SFM for virus-production applications. Most cell-culture–based viral vaccine production has historically been performed using anchorage-dependent cultures: The first large-scale virus culture of animal cells was accomplished in the 1950s using an array of 5-L glass (Povitsky) flasks. Today’s manufacturers can choose from a number of diverse formats supporting either attached or suspension cell cultures.
Interest in using well-developed and efficient stirred-tank bioreactor systems resulted in further developments for attachment-dependent culture platforms. One such accomplishment comes in the ability to culture the large numbers of adherent cells required to seed bioreactors of >1,000-L capacity. Other innovations supporting applications in vaccine manufacturing include microcarrier products with ultralow particulate counts, products amenable to gamma irradiation without loss of function, and distribution in convenient and compliant single-use bioprocess containers. Single-use technology has become an accepted component of bioproduction based on animal cells (Figure 4). Disposable components being used in vaccine manufacture include systems for process fluid mixing and storage, bulk material and product storage, filtration, and chromatography, as well as distribution manifolds, sensors, connectors, and production-scale bioreactors (14). Driven by technological innovations and such regulatory initiatives as process analytical technology (PAT) and QBD, bioprocess design — including for vaccine manufacturing — is in a period of significant development (17).
Virus stock generation techniques such as clone selection and plaque assays used to be performed manually using standard Petri dishes or multiwell plates. Initially, virus- or platform-specific culture considerations such as special nutritional or process requirements are addressed at small-scale in process development. For example, shear forces generated in shake, wave-action, or impeller-driven cultures as well as gas sparging can profoundly affect virally infected cells do to their compromised metabolism and weakened cell membranes.


New specialized procedures at such scales include those for such diverse activities as oncolytic virus production for cancer virotherapy, antiviral research, and testing for absorption, distribution, metabolism, excretion, and toxicity (ADMET). Everyone who signs up gets full access to our entire library, including our curated collections.
Our Standard license allows you to use images for anything, except large print runs over 500,000+ or for merchandising. Once you have downloaded your image, you have life-long rights to use it under the terms of the license purchased. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment. Such achievements herald exciting times both for classical vaccinology and for many new and developing technologies.
That seminal achievement eventually gave way to arrays of single-use roller bottles, which remain in significant use today. The general direction for all platforms is toward use of serum-free media (SFM) and animal-derived-component–free (ADCF) formulations, and the pressure for this transition is somewhat greater for human than for veterinary vaccines. Such advanced SFM formulation features have been accomplished for most cell lines used in other areas of bioproduction. But individual clone-selected or primary cell characteristics require optimization or even redesign of current formulations.
Mammalian cell lines include Vero (based on African green monkey kidney cells), Madin Darby canine kidney (MDCK) cells, baby hamster kidney 21 (BHK-21) cells, and chick embryo fibroblast (CEF) cells. Ambient culture medium has been demonstrated to influence such production parameters as time of infection, multiplicity of infection and time of harvest. However, along with such physiological consequences of infection as virus-induced host-cell defense and apoptosis, they have proven to be important events to consider in optimization of most virus yields.
The ability of a particular virus strain to replicate in certain cell lines does not necessarily directly correlate with its tissue-specific virulence in vivo (6) or the cells suspension or adherent phenotype.
Roller bottle use was originally developed at Johns Hopkins University for growing large quantities of adherent cells. Although many bioprocessors have long-since transitioned to using steam-in-place (SIP), stainless-steel, stirred-tank reactor systems, roller bottles remain in significant use today for legacy processes. These include an engineered extension of the T-flask: stacked-array reactors such as the Thermo Scientific Nunc Cell Factory system from Thermo Fisher Scientific (Figure 2). New low-density matrices that can be easily suspended in bioreactors come as solid or microporous substrates composed of diverse rigid or pliable materials. As the move from egg-based to cell-culture–based influenza vaccine production has accelerated, so too has the focus on overcoming some challenges associated with this platform. Microcarrier-based expansion in bioreactor seed trains has been demonstrated as a viable solution to this challenge. These specifically charged beads have demonstrated utility for supporting serial passage of many common cell lines as well as success in high-titer vaccine production with ADCF serum-free media (Figures 2 and 3, Table 1). Together, these developments support further advancement in vaccine manufacturing, such as the ability to provide single-use bioreactors (SUBs) preloaded with microcarriers for fully integrated systems. Both off-the-shelf and custom-designed systems are now in regular use to some extent as part of nearly every production process at contract manufacturing organizations (CMOs) and biopharmaceutical companies, including vaccine manufacturing (12).
Their acceptance by the vaccine industry is evidenced by both the number of companies successfully using them and in published applications (Figure 5).
Increased process understanding, novel analytics, and risk-based methods — and such goals as establishing a life-cycle approach, design space, and critical process parameters — have as much bearing on vaccines as any other products. Today, a number of specialized procedures using advanced, automated, and even high-content techniques provide product and process developers with increased understanding of virology and bioprocesses. Cell culture scale-up in vaccine manufacturing generally follows that of other bioproduction processes, and scale factors for transfer to intermediate levels (from 250 mL to a bench-top reactor) parallel traditional techniques for other applications. For reasons of convenience — and the tolerance of healthy cells in other bioprocesses to moderate hydrodynamic forces — such forces generated in large-scale agitation and sparging often are not accurately modeled at small scales. For example, three-dimensional hollow-fiber culture is being exploited as an inexpensive and accurate pharmacodynamic model for characterization of viral infection and antiviral approaches (21). Entirely new platforms such as plant-based production of virus-like particles (VLPs) present intriguing prospects for the near future. Guidance for Industry: Process Validation — General Principles and Practices, US Food and Drug Administration, Rockville. If at any time you're unsatisfied with your experience with us, you can cancel your subscription. Here we consider scaling up of vaccines and related hybrid, targeted, and conjugated viral therapeutics that are made through animal cell culture. Along with the newer platforms of stacked array flasks and macro- and microcarrier materials, roller bottles complement fed-batch suspension culture as popular platforms for vaccine manufacture.


But a number of virus and vaccine production formats still require proteins, hydrolysates, animal products, or other media components for optimum performance, which prohibits such designations. For even well-established cell lines, manufacturers’ desire for increased production efficiency often demands customization of feeds and final processes. All such lines were established and can be cultured in a basal medium with an added animal serum.
In the vaccine industry, primary drivers in process development and materials optimization include economic considerations such as production efficiency and cost containment, as well as the recent popularity of outsourcing elements of process development to experienced vendors with deep biomanufacturing experience. In many cases, very similar production media support viral vaccine production from infection-based, stably transfected or transduced cell lines.
In addition to increased surface area, the bottles exhibited other advantages over static cultures in preventing gradients from forming in cell culture media and in improving gas exchange with thinner layers of cell culture medium overlay. They provide robust, well-characterized solutions for some new products as well, for which other platforms have not yet been demonstrated. The scalable system provides a more compact footprint than do traditional roller bottle systems, and it comes in several versions with one to 40 trays and a range of culture media transfer mechanisms, port dimensions and styles, and other equipment to assist in handling. Specialty microcarriers present such characterized and designatable features as cross-linked polystyrene copolymer composition, cationic-modified surfaces, and buoyant densities (Table 3). Drivers for this rapid acceptance and widespread use in such a conservative industry have been well reviewed in recent years. Distinctions among systems offered include agitation and gas-sparging mechanisms, overall dimensions and fluid containment approaches, and applications data and support available.
Just as for other biologics, new guidance and regulations on these topics should help clarify the application of such programs for vaccine manufacturers (18,19). For example, videographic evidence revealed in 2010 that Vaccinia virus infections can demonstrate a “surfing” phenomenon (vigorous repulsion of superinfecting virions) with implications for both in vitro and in vivo infections (20). For some production formats, however, unique virus-production features need to be considered.
For many parameters, however, both micro- and small-scale stirred-tank bioreactor cultures are providing increased control for more accurate scaled-down modeling in process development studies, which allows for more rapid and effective transition into larger production formats (~25 L or greater). With an increasing number of specialized and personalized therapies under development, the concept of “scaling out” by using multiple small reactors — with each reactor designated to provide a patient-specific treatment — instead of “scaling up” to a single large bioreactor system is gaining popularity. Serum-Free Cell Culture System Supplemented with Lipid-rich Albumin for Hepatitis C Virus (strain O of genotype 1b) Replication.
Growth media for cells used in vaccine and related therapeutic applications begin with basal formulations often developed for each cell line in consideration of other purposes. But some transient-transfection or -transduced platforms require compositional adjustments.
Disposable plastic roller bottles appeared on the market in the mid-1970s and soon became a mainstay for vaccine production.
But the modern bottle shapes, plumbing and closure configurations, culture surface treatments, and housing apparatus would hardly be recognizable to those early culturists (Figure 2). Some of the most important to vaccine production include advantages in facility development and installation time, cost of goods, prevention of lot cross-contamination, rapid turn-around times, production scheduling flexibility, and surge capacity (13). The field remains in a state of rapid development, as evidenced by the recent introduction of an interesting new disposable system involving hollow-fiber bioreactors for virus production in vaccine manufacturing (15).
Many common goals are driving continued development of production-scale, GMP-compliant processes in the most economical and flexible platforms.
Virus-specific and product understanding considerations are numerous and include the fact that some virally infected cultures display a heightened or unique metabolite requirement and that some viruses require special culture media activities such as enzyme activation of virion components. Quality by design (QbD) principals apply to culture media as raw materials or components in regulated production (7).
The number of new therapeutic technologies involving culture of primary or continuous cell lines for gene therapy, vaccine, and new related techniques is large and continues to grow. It is still in progress today, as evidenced by Baxter International’s recent European introduction of influenza vaccine produced by Vero cell culture. Beyond such general guidelines, for example, specific US regulations cover culture media for human ex vivo tissue and cell culture processing (8), and US guidance on biological materials in vaccine production includes such media components as serum and trypsin (9,10). Combining single-use production systems with modular, portable, cleanroom technology promises low-cost, flexible, vaccine-manufacturing facilities that comply with good manufacturing practices (GMPs) to assist developing countries and provide all with swift pandemic response (16).
And the soon-to-open Novartis plant in Holly Springs, NC, one of the first producing flu vaccine by cell culture in the United States.



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