Presentations

  • Insulin is a relatively low-priced drug
  • Chronic nature of Diabetes means the cost for insulin treatment is high, and together with an increasing number of patients
  • This financial burden challenges healthcare systems worldwide
  • Its price reduction is needed in order to improve its availability especially in lower to lower-middle income countries Fig. 1 Insulin in the form of infusion

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Original Publication Date: 03/18/2019

The bioprocessing industry is interested in Next Generation Processes with higher flexibility, lower costs, and higher product quality. Single-pass tangential flow filtration (SPTFF) can be used to intensify manufacturing processes to meet these goals. Here, SPTFF preconcentration is used to intensify the anion exchange (AEX) polishing step in monoclonal antibody (mAb) processing for improved impurity removal and column productivity. This intensified polishing approach can be linked with upstream steps for a more continuous process which eliminates tankage and hold time, and enables the use of smaller polishing columns to improve productquality at higher throughputs.

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Original Publication Date: 11/10/2017

Tangential Flow Filtration (TFF) is a separation process that uses membranes to separate components in a liquid solution or suspension on the basis of size or molecular weight differences.
Pellicon® cassettes combine the advantages of efficient, gentle processing, and linear scalability for effective, predictable scale-up from laboratory to process applications.

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Original Publication Date: 07/04/2017

Evaluate high pressure refolding

  • For our specific manufactured molecular formats on a variety of model proteins
  • Develop experimental approach for fast optimization of process parameters
  • Compare structure, stability, and activity of the protein variants refolded with high pressure vs. conventional methods
  • Identify potential economic benefits of high pressure compared with conventional refolding

Evaluate high pressure for the dissolution of soluble protein aggregates

  • Using process-related aggregates of a relevant model protein
  • Show that solubilized monomers have native structure

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Original Publication Date: 10/26/2016

The rise of the Internet, social media, and communications technology has transformed consumer behavior. Consumers today are better informed, expect a high-level of engagement, and a modern service experience. Shay Brill, vice president of corporate development for Atlantic Research Group, in a white paper released at the recent Global Genes Rare Patient Advocacy Summit, argues that similar changes are underway in the behavior of patient-consumers. We spoke to Brill about these trends, how they're is changing drug developers' relationships with patients, and what these changes mean for sponsors of clinical trials. Learn More

For cultivation of mammalian cells in biopharmaceutical research and manufacturing, single-use technology possesses several advantages to autoclavable material. Bioreactor scalability is critical to streamlining the adaptation of culture volumes during process development and manufacturing. We analyzed BioBLU Single-Use Vessels of different sizes (maximum working volumes of 0.25 L, 3.75 L, and 40 L) that are of geometrically similar stirred-tank design. We identified a scalable tip speed zone and an overlapping range of kLa values, which cover most mammalian cell culture needs. Using computational fluid dynamics simulations we determined the power numbers of the BioBLU bioreactors. Based on these data we scaled up a process for production of monoclonal antibodies (mAb) in CHO cells from 0.25 L to 3.75 L to 40 L by keeping constant P/V values (impeller power consumption per liquid volume) among the differently sized vessels. Similar cell growth curves and mAb production profiles were achieved at all three scales. In summary, this study demonstrates the excellent scalability of the single-use bioreactors tested.

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Original Publication Date: 06/01/2016

Continuous manufacturing (CM) is a process technology that has been used in the chemical industry for large‐scale mass production of chemicals in single‐purpose plants with benefit for many years. Recent interest has been raised to expand CM into the low‐volume, high‐value pharmaceutical business with its unique requirements regarding readiness for human use and the required quality, supply chain, and liability constraints in this business context. Using a fairly abstract set of definitions, this paper derives technical consequences of CM in different scenarios along the development–launch–supply axis in different business models and how they compare to batch processes. Impact of CM on functions in development is discussed and several operational models suitable for originators and other business models are discussed and specific aspects of CM are deduced from CM's technical characteristics. Organizational structures of current operations typically can support CM implementations with just minor refinements if the CM technology is limited to single steps or small sequences (bin‐to‐bin approach) and if the appropriate technical skill set is available. In such cases, a small, dedicated group focused on CM is recommended. The manufacturing strategy, as centralized versus decentralized in light of CM processes, is discussed and the potential impact of significantly shortened supply lead times on the organization that runs these processes. The ultimate CM implementation may be seen by some as a totally integrated monolithic plant, one that unifies chemistry and pharmaceutical operations into one plant. The organization supporting this approach will have to reflect this change in scope and responsibility. The other extreme, admittedly futuristic at this point, would be a highly decentralized approach with multiple smaller hubs; this would require a new and different organizational structure. This processing approach would open up new opportunities for products that, because of stability constraints or individualization to patients, do not allow centralized manufacturing approaches at all. Again, the entire enterprise needs to be restructured accordingly. The situation of CM in an outsourced operation business model is discussed. Next steps for the industry are recommended. In summary, opportunistic implementation of isolated steps in existing portfolios can be implemented with minimal organizational changes; the availability of the appropriate skills is the determining factor. The implementation of more substantial sequences requires business processes that consider the portfolio, not just single products. Exploration and implementation of complete process chains with consequences for quality decisions do require appropriate organizational support.

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Original Publication Date: 01/28/2015

This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small‐molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady‐state values; (2) the design of start‐up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first‐principles and empirical model‐based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first‐principles models and control systems technologies for drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high‐quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas.

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Original Publication Date: 12/26/2014

This white paper focuses on equipment, and analytical manufacturers’ perspectives, regarding the challenges of continuous pharmaceutical manufacturing across five prompt questions. In addition to valued input from several vendors, commentary was provided from experienced pharmaceutical representatives, who have installed various continuous platforms. Additionally, a small medium enterprise (SME) perspective was obtained through interviews. A range of technical challenges is outlined, including: the presence of particles, equipment scalability, fouling (and cleaning), technology derisking, specific analytical challenges, and the general requirement of improved technical training. Equipment and analytical companies can make a significant contribution to help the introduction of continuous technology. A key point is that many of these challenges exist in batch processing and are not specific to continuous processing. Backward compatibility of software is not a continuous issue per se. In many cases, there is available learning from other industries. Business models and opportunities through outsourced development partners are also highlighted. Agile smaller companies and academic groups have a key role to play in developing skills, working collaboratively in partnerships, and focusing on solving relevant industry challenges. The precompetitive space differs for vendor companies compared with large pharmaceuticals. Currently, there is no strong consensus around a dominant continuous design, partly because of business dynamics and commercial interests. A more structured common approach to process design and hardware and software standardization would be beneficial, with initial practical steps in modeling. Conclusions include a digestible systems approach, accessible and published business cases, and increased user, academic, and supplier collaboration. This mirrors US FDA direction. The concept of silos in pharmaceutical companies is a common theme throughout the white papers. In the equipment domain, this is equally prevalent among a broad range of companies, mainly focusing on discrete areas. As an example, the flow chemistry and secondary drug product communities are almost entirely disconnected. Control and Process Analytical Technologies (PAT) companies are active in both domains. The equipment actors are a very diverse group with a few major Original Equipment Manufacturers (OEM) players and a variety of SME, project providers, integrators, upstream downstream providers, and specialist PAT. In some cases, partnerships or alliances are formed to increase critical mass. This white paper has focused on small molecules; equipment associated with biopharmaceuticals is covered in a separate white paper. More specifics on equipment detail are provided in final dosage form and drug substance white papers. The equipment and analytical development from laboratory to pilot to production is important, with a variety of sensors and complexity reducing with scale. The importance of robust processing rather than overcomplex control strategy mitigation is important. A search of nonacademic literature highlights, with a few notable exceptions, a relative paucity of material. Much focuses on the economics and benefits of continuous, rather than specifics of equipment issues. The disruptive nature of continuous manufacturing represents either an opportunity or a threat for many companies, so the incentive to change equipment varies. Also, for many companies, the pharmaceutical sector is not actually the dominant sector in terms of sales.

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Original Publication Date: 12/1/2014

There is a growing interest in realizing the benefits of continuous processing in biologics manufacturing, which is reflected by the significant number of industrial and academic researchers who are actively involved in the development of continuous bioprocessing systems. These efforts are further encouraged by guidance expressed in recent US FDA conference presentations. The advantages of continuous manufacturing include sustained operation with consistent product quality, reduced equipment size, high‐volumetric productivity, streamlined process flow, low‐process cycle times, and reduced capital and operating cost. This technology, however, poses challenges, which need to be addressed before routine implementation is considered. This paper, which is based on the available literature and input from a large number of reviewers, is intended to provide a consensus of the opportunities, technical needs, and strategic directions for continuous bioprocessing. The discussion is supported by several examples illustrating various architectures of continuous bioprocessing systems.

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Original Publication Date: 11/21/2014

We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to continuous manufacturing. We also give the key motivations for moving to continuous manufacturing, some of the exciting new technologies, and the barriers to implementation of continuous manufacturing. Continuous processing of heterogeneous blends is the natural first step in converting existing batch processes to continuous. In heterogeneous processing, there are discrete particles that can segregate, versus in homogeneous processing, components are blended and homogenized such that they do not segregate. Heterogeneous processing can incorporate technologies that are closer to existing technologies, where homogeneous processing necessitates the development and incorporation of new technologies. Homogeneous processing has the greatest potential for reaping the full rewards of continuous manufacturing, but it takes long‐term vision and a more significant change in process development than heterogeneous processing. Heterogeneous processing has the detriment that, as the technologies are adopted rather than developed, there is a strong tendency to incorporate correction steps, what we call below “The Rube Goldberg Problem.” Thus, although heterogeneous processing will likely play a major role in the near‐term transformation of heterogeneous to continuous processing, it is expected that homogeneous processing is the next step that will follow.

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Original Publication Date: 12/12/2014

Yeast - eukaryotic organism that classified under fungi kingdom - replicate rapidly (doubling time) and reproduce asexually by budding

Yeast fermentation - involve anaerobic respiration to breakdown carbohydrate to produce ethanol & carbon dioxide - Yeast used to break down pyruvic acid to produce ethanol - produced by batch using fed batch reactor

Centrifugation - a process used to separate the mixture by spinning at high speed

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Original Publication Date: 01/27/2018

Typical motionless bioreactor where the internal circulation and mixing are achieved by bubbling air.”

Employ forced/ pressurized air to circulate cells and nutrient medium.

Can be used to culture cells that highly shear-sensitive.

Gas stream facilitate exchange of material between the gas phase and the medium.

Oxygen is usually transferred to the liquid, products are removed through exchange with the gas phase.

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Original Publication Date: 01/11/2013

Analysis of bioreactor parameters online and offline.

Unfortunately, there are a few instruments for continuous monitoring of cell properties in a bioreactor. The most basic measurement needed is total biomass content or concentration or, better still, active biomass concentration. Although a number of possible methods exists, no approach has yet been invented which provides such data reliability, consistently, and for a broad class of organisms and media.

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Original Publication Date: 04/08/2015

The heart of the fermentation or bioprocess technology is the Fermentor or Bioreactor. A bioreactor is basically a device in which the organisms are cultivated to form the desired products. it is a containment system designed to give right environment for optimal growth and metabolic activity of the organism.
A fermentor usually refers to the containment system for the cultivation of prokaryotic cells, while a bioreactor grows the eukaryotic cells (mammalian, insect cells, etc).

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Original Publication Date: 02/20/2014

Genetically modified plants can be manipulated to act as bioreactors to produce wide range of biologically important compounds.

These include carbohydrate, lipids, protein, besides the secondary product.

The commercial products of plants are useful for industries of improving the human and animal health.

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Original Publication Date: 01/07/2019

A device in which a substrate of low value is utilized by living cells to generate products of higher value.

From earlier days - Microbes & animal cell culture used to produce biomolecules.

Advancement in plant engineering : Possible to use as bioreactors.

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Original Publication Date: 07/02/2011

A Bioreactor is defined as a closed system used for bioprocessing (flask, roller bottle, tank, vessel, or other container), which supports the growth of cells, mammalian or bacterial, in a culture medium. A bacterial reaction usually is said to take place in a fermenter, and cell culture in a bioreactor.

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Original Publication Date: 05/06/2017

Bioreactor: A bioreactor may refer to a device or system meant to grow animal cells or tissues in the context of cell culture. These devices are being developed for use in tissue engineering or biochemical engineering.

Fermenter: Fermenters are well established for the cultivation of microbes ,proteins ,industrial product(acetic acid, alcohol etc.) under monitored ,controlled environmental and operational conditions up to an industrial scale.

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Original Publication Date: 12/21/2016

ransient production of proteins in mammalian cells is fundamental to studies on gene function in health and disease. Many viral and plasmid vectors are available to enable the transfer of genes into mammalian cells, including baculovirus vectors.

Baculoviruses are insect-specific viruses that can transduce but not replicate in many mammalian cells. These BacMAM vectors utilise mammalian promoters to drive expression of target genes. One disadvantage of the current BacMAM system is that relatively high multiplicities of infection (50-200+ virus particles per cell) are often required for effective transduction.
This requires either concentration of the BacMAM virus (time-consuming/ labour intensive) or the use of chemical enhancers.

This study demonstrates that incorporation of a natural mutation in the FP25 gene into the BacMAM backbone vector can increase budded virus titres by several fold. Thus transduction efficacies can be improved without the need for concentration of virus or the use of chemical enhancers.

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Original Publication Date: 10/16/2014

Monoclonal antibodies (mAbs) are important biopharmaceuticals for the treatment of many diseases. During manufacturing the proteins tend to form aggregates, which reduce product yields, influence drug performance and safety. Environmental conditions during production in mammalian cell culture influence the formation of high molecular weight (HMW) species. In this report, we show how mAb aggregates can be detected directly in the cell culture supernatant using size exclusion chromatography (SEC) in a high pressure liquid chromatography (HPLC) system. We have investigated the impact of batch cultivation in different culture vessels, the addition of Valproic acid (VPA) as small molecule enhancer of protein production and the influence of the cell culture environment itself on the formation of mAb aggregates in Chinese hamster ovary (CHO) cell culture. Our results prove that aggregate formation can occur already during upstream processing (USP) due to intracellular and extracellular mechanisms and is not only a problem in downstream processing (DSP).

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Original Publication Date: 09/24/2014

Culturing and direct online morphological observation of human cells1 is important in several biomedical research areas, including drug screening, stem cell research, zygote research and biomaterials science. We have realized a micro cell culture chip that meets the fastidious demands of human cell culturing2. The transparency of the chip and implementation of continuous media perfusion enabled long term cell culturing2 and real time morphological observations directly on the microscope stage.

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Original Publication Date: 12/19/2013

Measurements of kLa values, namely the volumetric mass-transfer coefficient describing efficiency with which oxygen can be delivered for a given set of conditions, provides important information about cell culture bioprocesses. It also provides an efficiency measure of the bioreactor system used. The dissolved oxygen (DO) level is often the limiting substrate in fermentation and cell culture processes. For bacteria and yeast cultures in particular there is a critical oxygen concentration above which it no longer limits growth. It is therefore important to be able to maintain DO levels above this critical level by sparging the bioreactor system with air or pure oxygen. In addition the mass transfer rate of oxygen should be equal to, or exceed, the rate to which the growing cells take up the oxygen. Determination of kLa values therefore provides information that enable one to ensure that an adequate supply of oxygen is available for the most efficient proliferation of the cell culture.

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Original Publication Date: 05/06/2015

Process Analytical Technology currently becomes more and more important for food and pharmaceutical industry for example because of the increasing demand for more effective and efficient quality control. Therefore it is necessary to get timely and targeted responses of the different parameters in bioprocesses. To attain this aim, it is helpful to replace the conventional (manual) laboratory techniques with automated measuring processes via in-line probe.

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Original Publication Date: 12/20/2013

This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily “continuous processing”‐based supply chain. The current predominantly “large batch” and centralized manufacturing system designed for the “blockbuster” drug has driven a slow‐paced, inventory heavy operating model that is increasingly regarded as inflexible and unsustainable. Indeed, new markets and the rapidly evolving technology landscape will drive more product variety, shorter product life‐cycles, and smaller drug volumes, which will exacerbate an already unsustainable economic model. Future supply chains will be required to enhance affordability and availability for patients and healthcare providers alike despite the increased product complexity. In this more challenging supply scenario, we examine the potential for a more pull driven, near real‐time demand‐based supply chain, utilizing continuous processing where appropriate as a key element of a more “flow‐through” operating model. In this discussion paper on future supply chain models underpinned by developments in the continuous manufacture of pharmaceuticals, we have set out;

  • The significant opportunities to moving to a supply chain flow‐through operating model, with substantial opportunities in inventory reduction, lead‐time to patient, and radically different product assurance/stability regimes.
  • Scenarios for decentralized production models producing a greater variety of products with enhanced volume flexibility.
  • Production, supply, and value chain footprints that are radically different from today's monolithic and centralized batch manufacturing operations.
  • Clinical trial and drug product development cost savings that support more rapid scale‐up and market entry models with early involvement of SC designers within New Product Development.
  • The major supply chain and industrial transformational challenges that need to be addressed.

The paper recognizes that although current batch operational performance in pharma is far from optimal and not necessarily an appropriate end‐state benchmark for batch technology, the adoption of continuous supply chain operating models underpinned by continuous production processing, as full or hybrid solutions in selected product supply chains, can support industry transformations to deliver right‐first‐time quality at substantially lower inventory profiles.

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Original Publication Date: 01/28/2015

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.

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Original Publication Date: 01/14/2015

An important aspect of any biotechnological processes is the culture of animal cells in artificial media. Cultured animal cells are used in recombinant DNA technology, genetic manipulations and in a variety of industrial processes with economic potential. In production of vaccines, monoclonal antibodies, pharmaceutical drugs, cancer research, etc.

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Original Publication Date: 03/26/2019

Objective

  • STEM CELL HISTORY
  • Stem Cell Definitions
  • Why are stem cells important
  • Classification of stem cells based on their dividing capacity
  • Culturing Stem Cells Embryonic
  • Bone marrow
  • Umbilical Human Cord culture
  • References

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Original Publication Date: 12/23/2015

Cell culture is the process by which prokaryotic, eukaryotic or plant cells are grown under controlled conditions. But in practice it refers to the culturing of cells derived from animal cells. Cell culture was first successfully undertaken by Ross Harrison in 1907. Roux in 1885 for the first time maintained embryonic chick cells in a cell culture.

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Original Publication Date: 08/11/2014

This presentation covers the introduction to Insect Cell Culture. Also covers its general information about cell culture practices followed in the lab. It covers culture media, the source of cells for culture and examples of the cell line with their culture conditions.

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Original Publication Date: 03/08/2019

in-vitro culture (maintain and/or proliferate) of cells ,tissue or organs

Types of tissue culture:

  • Organ culture
  • Tissue culture
  • Cell culture
  • Histotypic Culture
  • Organotypic Culture
  • Primary culture
  • Cell line

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Original Publication Date: 03/13/2019

What is Cell Culture?

  • In vitro culture (maintain and/or proliferate) of cells, tissues or organs
  • Types of tissue culture
    • Organ culture
    • Tissue culture
    • Cell culture

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Original Publication Date: 12/15/2008

In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion

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Original Publication Date: 11/10/2017

Downstream, upstream, fermentation in bioprocessing

  • A bioprocess is a specific process that uses complete living cells or their components (e.g., bacteria, enzymes, chloroplasts) to obtain desired products.
  • Bioprocessing and Biotechnology is very similar as in biotechnology we take different microorganisms to develop or make a product through different technological applications.
  • In Biotechnology, Bioprocessing is a kind of bioengineering.

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Original Publication Date: 10/15/2017

  • Production of commercially desired products operated at very small scale.
  • Speeds up the delivery of new products.
  • Reduces developmental costs.
  • Increases consumer benefit.
  • Rapidly evaluates the bioprocess options.

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Original Publication Date: 10/27/2017

CHI’s Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today's complex biopharmaceuticals, from early development through commercial. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follows. We then step through the stages of bioprocessing, beginning with the development of cell lines and ending at the packaging of a finished drug product. The seminar also explores emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles played by the analytical and formulation in developing and gaining approval for a biopharmaceutical are also examined. This 1.5-day class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from a detailed overview of this field.

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Original Publication Date: 10/03/2014

One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.

But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?

In this dedicated supplement, experts from both biologics manufacturers and from MilliporeSigma provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.

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Original Publication Date: 02/05/2019

Introduction Process intensification is an approach to improve operational throughput by running a manufacturing process or unit operation differently. In mAb purification, intensified processing can remove bottlenecks created by high bioreactor titers, increase manufacturing flexibility for multi-product facilities, and reduce cost of goods while increasing the focus on product quality. This work focuses on intensifying the anion exchange (AEX) mAb polishing step. AEX polishing is commonly used to provide clearance of host cell protein (HCP) and virus impurities.

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Original Publication Date: 09/01/2017

The use of cellular assays in drug screening continues to grow with over 50% of primary screens using cell-based formats in 2006. The majority of cells used in the drug discovery industry are fresh, using 'just in time' batch processing from in-house facilities. This process could give rise to a number of issues, namely batch variation, scheduling of cell production and capacity management. We describe the use of microcarrier technology in combination with a suitably configured bioreactor to provide a rapid, robust and reproducible approach to cell production. Cells cultured in this way can be removed from beads, cryopreserved in a single HTS batch size format and maintain assay capacity. Learn More

In August of 2008, company representatives from Abbott, Amgen, Eli Lilly, Genentech, GSK, MedImmune and Pfizer were brought together to help advance the principles contained in ICH Q8 (R2), Q9 and Q10, focusing on the principles of Quality by design. Through a series of inter-company and regulatory interactions, the group set out to create a study that would stimulate discussion around how the core principles contained in these guidelines would be applied to product realization programs, with a multitude of real-world scenarios, as opposed to a singular approach. Learn More

Editors Choice from AspenXchange

Monoclonal antibodies (mAbs) are important biopharmaceuticals for the treatment of many diseases. During manufacturing, the proteins tend to form aggregates, which reduce product yields, influence drug performance and safety. Environmental conditions during production in mammalian cell culture influence the formation of high molecular weight (HMW) species. In this report, we show how mAb aggregates can be detected directly in the cell culture supernatant using size exclusion chromatography (SEC) in a high pressure liquid chromatography (HPLC) system. We have investigated the impact of batch cultivation in different culture vessels, the addition of Valproic acid (VPA) as small molecule enhancer of protein production and the influence of the cell culture environment itself on the formation of mAb aggregates in Chinese hamster ovary (CHO) cell culture. Our results prove that aggregate formation can occur already during upstream processing (USP) due to intracellular and extracellular mechanisms and is not only a problem in downstream processing (DSP).
Learn More

Editors Choice from AspenXchange

This study evaluates a number of techniques that influence the accuracy and precision of the pipetted volume. The pipette operator has the ability to control all of these parameters by using the appropriate pipetting technique, as well as by choosing the appropriate pipette size and type of pipette tips.

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We have investigated the impact of batch cultivation in different culture vessels, the addition of Valproic acid (VPA) as small molecule enhancer of protein production and the influence of the cell culture environment itself on the formation of mAb aggregates in Chinese hamster ovary (CHO) cell culture. Our results prove that aggregate formation can occur already during upstream processing (USP) due to intracellular and extracellular mechanisms and is not only a problem in downstream processing (DSP).


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The demand for more efficiency and productivity in the laboratory has led to applications using Fast GC-MS methods for routine analysis in a wide range of fields. Many of these applications can involve complex mixtures with some components at trace levels. The fast analysis time requires some unique capabilities, including a GC with fast column heating and cooling for high throughput, a mass spectrometer with high data acquisition speed, and a fast response ion source in order to correctly characterize narrow peaks generated by Fast GC.

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