Cellca is a leading provider of Cell Line Development Services allowing customers easy open access to a cost effective reliable technology platform consistently delivering well characterised stable research clones from DNA to Research Cell Bank (RCB) in 4 months with titres upwards of 3.0 g/L in an easily scalable fed batch process.
Integration of Cell Line and Process Development to Expedite Delivery of Bisp...KBI Biopharma
Authored and Presented by: Dane A. Grismer, Yogender K. Gowtham, Srivatsan Gopalakrishnan, David. W. Chang,
Niket Bubna, Ph.D., and Sigma S. Mostafa, Ph.D.
Developing a Scalable Upstream Bioreactor Process for Lentiviral Vector Produ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b3Jc77
Gene therapies hold the promise to change lives. As your path to patients accelerates, how can you assure the robust process design, intensification and scalability that meets your evolving manufacturing needs? What benefits can a templated process bring to your commercial success?
As gene therapy progresses toward broader clinical and commercial success, the industry is shifting from treating rare conditions to those of larger populations. This requires scalable solutions for process intensification. In this webinar, we’ll discuss scale-up development for a common viral vector in gene therapy, lentivirus, using the VirusExpress™ Lentiviral Production Platform in Mobius® single-use bioreactors. We will highlight critical considerations when moving from bench-scale to clinical scale process design with manufacturability in mind to ensure commercial readiness. Finally, we’ll review the significant benefits of implementing a templated manufacturing process.
In this webinar you will learn:
• Scale-up development of a suspension-based lentivirus production process
• Designing a process that is manufacturing-friendly and supports commercialization
• The benefits of having a templated manufacturing process
A Vaccine Approach against HIV-1, Manufacturing Env proteins: from Bench to B...KBI Biopharma
A Vaccine Approach against HIV-1, Manufacturing Env proteins: from Bench to Bedside
Abhinav A.Shukla, Ph.D. Senior Vice President, Process Development & Manufacturing, KBI Biopharma
Prof.Barton Haynes,M.D.Director,Duke Human Vaccine Institute
Next Generation Recombinant Protein ManufacturingKBI Biopharma
Next Generation Processes: What Model Works Best to Manufacture Recombinant Proteins in Asia?
BioPharma Asia 2017
Suntec Convention Center. Singapore, March 22, 2017
Thomas Jung, M.S. Vice President, Business Development
KBI Biopharma Inc.
Integration of Cell Line and Process Development to Expedite Delivery of Bisp...KBI Biopharma
Authored and Presented by: Dane A. Grismer, Yogender K. Gowtham, Srivatsan Gopalakrishnan, David. W. Chang,
Niket Bubna, Ph.D., and Sigma S. Mostafa, Ph.D.
Developing a Scalable Upstream Bioreactor Process for Lentiviral Vector Produ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b3Jc77
Gene therapies hold the promise to change lives. As your path to patients accelerates, how can you assure the robust process design, intensification and scalability that meets your evolving manufacturing needs? What benefits can a templated process bring to your commercial success?
As gene therapy progresses toward broader clinical and commercial success, the industry is shifting from treating rare conditions to those of larger populations. This requires scalable solutions for process intensification. In this webinar, we’ll discuss scale-up development for a common viral vector in gene therapy, lentivirus, using the VirusExpress™ Lentiviral Production Platform in Mobius® single-use bioreactors. We will highlight critical considerations when moving from bench-scale to clinical scale process design with manufacturability in mind to ensure commercial readiness. Finally, we’ll review the significant benefits of implementing a templated manufacturing process.
In this webinar you will learn:
• Scale-up development of a suspension-based lentivirus production process
• Designing a process that is manufacturing-friendly and supports commercialization
• The benefits of having a templated manufacturing process
A Vaccine Approach against HIV-1, Manufacturing Env proteins: from Bench to B...KBI Biopharma
A Vaccine Approach against HIV-1, Manufacturing Env proteins: from Bench to Bedside
Abhinav A.Shukla, Ph.D. Senior Vice President, Process Development & Manufacturing, KBI Biopharma
Prof.Barton Haynes,M.D.Director,Duke Human Vaccine Institute
Next Generation Recombinant Protein ManufacturingKBI Biopharma
Next Generation Processes: What Model Works Best to Manufacture Recombinant Proteins in Asia?
BioPharma Asia 2017
Suntec Convention Center. Singapore, March 22, 2017
Thomas Jung, M.S. Vice President, Business Development
KBI Biopharma Inc.
How to reach High Plasma Protein Concentration with Single-Pass TFFMerck Life Sciences
This webinar will discuss our collaboration with Takeda on the development of a single-pass TFF system as an alternative to traditional TFF for concentrating a plasma-derived IgG solution.
Single-Pass Tangential Flow Filtration (SPTFF) is a technology that requires only one pass through the filter assembly to achieve the desired concentration with no recirculation of product.
SPTFF can offer many advantages in downstream processing, such as:
• Increased capacity and reduced process time
• Increased yield and product recovery
• Optimized processing of highly shear-sensitive products
• Reduced foam formation
• Reduced cost of goods
This presentation will cover our collaboration with Takeda, formerly Shire, for the development of a specific SPTFF system as an alternative to traditional TFF for concentrating a plasma-derived Immunoglobulin G (IgG) solution from 10% to 20%. Due to promising results, plans are underway to replace the currently used batch TFF process with a SPTFF step.
In this webinar, we will discuss:
- A comparison of traditional TFF versus SPTFF
- Design of Experiments (DOE) approach toward initial process development work and determination of the optimal parameters
- Process run results, including final product yield and product quality
Complete single-use ADC technology from development through scale-up MilliporeSigma
This webinar will talk about the benefits of single-use technologies for the manufacturing of antibody-drug conjugates and present a successful corresponding case study.
With an expected high annual growth rate of the global Antibody-drug Conjugate (ADC) market, it is essential that CMO’s have robust manufacturing platforms to ensure successful transfer to GMP production.
Single-Use Technologies provide many advantages, including improved safety, lower costs and greater flexibility. This webinar will outline the advantages of a Single Use Platform and give a case study on how it can be used to manufacture ADC projects.
In this webinar, you will learn:
● How single-use technologies can provide benefits for ADC manufacturing
● Why a solid manufacturing platform is crucial for a successful transfer to GMP production
● How a case study demonstrates the advantages of single-use equipment in a scale up to GMP production
Accelerating cell therapy manufacturing through robust process development - ...MilliporeSigma
Watch the webinar here: https://bit.ly/2WFoinn
Industry trends in regenerative medicine highlight a critical need for automated and closed manufacturing to support scalable production. With over 1,000 clinical trials underway worldwide utilizing the RM/AT designation, it's increasingly more important that successful clinical trials translate to marketable treatments. To ensure proper translation, manufacturing strategies must generate products that are effective, safe, consistent and help reduce costs. To achieve this goal, fit-for-purpose solutions are required.
This webinar presents an introduction to our fit-for-purpose cell therapy manufacturing solution, the ekko™ cell processing system. We will share process development strategies through case studies that support a variety of unit operation steps across cell types, including but not limited to, wash and concentration of T cells and aggregate processing of induced pluripotent cells.
The goal of our presentation is to share process development strategies for solutions that can be seamlessly translated and implemented for use in commercial production.
In this webinar, you will learn:
* Manufacturing trends for closed and automated cell therapy processes and requirements for industrialization of cell therapies
* Introduction to acoustic cell processing and how it works
* Process optimization with case studies across a variety of cell types and unit operations
Host Cell Protein Analysis by Mass Spectrometry | KBI BiopharmaKBI Biopharma
Host Cell Protein Analysis by Mass Spectrometry. Originally presented at the 2018 Sciex Users Meeting by Michael J Nold, Ph.D., Mass Spectrometry Core Facility at KBI Biopharma.
From Screening to QC: Development Considerations for Octet MethodsKBI Biopharma
The Octet is a powerful platform that can be used for rapid binding analysis of samples throughout development, stability testing and can be implemented or release of GMP material. For potency analysis of GMP materials, methods must demonstrate precision, accuracy, specificity and linearity across the range of specifications.
Watch the webinar now: http://bit.ly/scale-up-webinar
Flexibility and speed are key for the development of a new drug, from research to clinic and from clinic to market. Being able to produce a batch at the right time and at the right size is required to handle clinical trials in a fast and cost effective manner. For that purpose, a robust process is mandatory but its scalability makes a difference. During this session, we will describe our method to ensure efficient process tech transfer from a 3L to a 2000L bioreactor, straight forward. The knowledge generated during process development, as well as a specific model designed to keep the oxygen mass transfer coefficient (KLa) stable in any bioreactor, drive the success of such a challenge.
In this webinar, you will learn:
- How to modelize oxygen uptake in a bioreactor
- How to use this model and scale-up a process
- How to liaise with harvesting through clarification
High Productivity Membrane Chromatography: Enabling the Next Generation Biopr...Merck Life Sciences
A novel single-use chromatography platform enabling cost-efficient manufacturing to support the growing global demand for affordable biologics.
A new single-use (per batch) chromatography platform employs traditional, proven chemistries in an inventive hydrogel polymer membrane format that enables the next generation bioprocessing paradigm. The experimental Protein A membrane, featuring a 10-fold improvement in productivity over resin columns and high selectivity (i.e. 3 LRV HCP), is combined with high performance membranes with mixed mode and ion exchange modalities for a fully single-use membrane-based purification process. The membrane columns show protein capacities similar or superior to reference resins in bind and elute, and up to 7 LRV clearance of MVM at 20kg/L in flow through mode. A membrane-based process allows a holistic process strategy involving small footprint, high throughput processing by means of a rapid multi-cycling capture step (up to 100 cycles per batch) and high capacity flow through polishing. This single-use (per batch) platform results in simple, compact, flexible, yet robust and safe downstream operations for cost-efficient manufacturing to support the growing demand for affordable biologics.
In this webinar, you will learn about:
• Advantages of a fully single-use membrane-based purification processes
• High capacity flow through polishing with an inventive membrane adsorber combining the best of resins (DBC) and membranes (30x of flow rate)
Scalability of a Single-Use Bioreactor Platform for Biopharmaceutical Manufac...KBI Biopharma
Presented at PepTalk 2017: San Diego, CA
Niket Bubna, Principal Scientist, Process Development, KBI Biopharma
Single-use Technologies And Continuous Processing
(Advancing Bioprocessing Through Technological Innovation)
Risk Mitigation Strategies For Single-use Technologies
Integrated utilization of high-throughput bioreactors & high-throughput analy...KBI Biopharma
There is a strong impetus towards rapidly advancing an increasing number of novel biotherapeutics to clinical trials. However, development of cell culture processes is labor intensive and time consuming. KBI focuses on a high throughput process development (HTPD) approach using high-throughput miniaturized bioreactors and high throughput analytics that generate growth, productivity and product quality data that match those seen with classical systems. This approach enables a significant reduction in the cell culture process development timeline and costs for investigational biopharmaceuticals to reach the clinic.
Presentation at BPI West by Abhinav A. Shukla, Ph.D. Senior Vice President Development & Manufacturing KBI Biopharma, Durham NC, February 27 – March 2, 2017, Platforms for mAb Commercialization
A key bottleneck for mammalian cell culture productivity is the extended duration of the process with inoculum seed train and production culture stretching between 4-6 weeks in duration. Introducing flexibility in scheduling and execution of cell culture manufacturing campaigns with via a reduction in process duration can be a key strategy for maximizing facility utilization and facilitating the progression of multiple therapeutics to clinical trials. In this work, we investigated the initiation of CHO cell culture production runs using seed cultures cryopreserved in large disposable bags.
Optimization of Glycosyation & Charge Distribution Through Culture Parameters...KBI Biopharma
Introduction – KBI workflow
•Case study 1 – PAT approach to meet charge species target
•Case study 2 – Product quality toolbox
•Case study 3 – Impact of Cu2+ on product quality
•Conclusions
How to reach High Plasma Protein Concentration with Single-Pass TFFMerck Life Sciences
This webinar will discuss our collaboration with Takeda on the development of a single-pass TFF system as an alternative to traditional TFF for concentrating a plasma-derived IgG solution.
Single-Pass Tangential Flow Filtration (SPTFF) is a technology that requires only one pass through the filter assembly to achieve the desired concentration with no recirculation of product.
SPTFF can offer many advantages in downstream processing, such as:
• Increased capacity and reduced process time
• Increased yield and product recovery
• Optimized processing of highly shear-sensitive products
• Reduced foam formation
• Reduced cost of goods
This presentation will cover our collaboration with Takeda, formerly Shire, for the development of a specific SPTFF system as an alternative to traditional TFF for concentrating a plasma-derived Immunoglobulin G (IgG) solution from 10% to 20%. Due to promising results, plans are underway to replace the currently used batch TFF process with a SPTFF step.
In this webinar, we will discuss:
- A comparison of traditional TFF versus SPTFF
- Design of Experiments (DOE) approach toward initial process development work and determination of the optimal parameters
- Process run results, including final product yield and product quality
Complete single-use ADC technology from development through scale-up MilliporeSigma
This webinar will talk about the benefits of single-use technologies for the manufacturing of antibody-drug conjugates and present a successful corresponding case study.
With an expected high annual growth rate of the global Antibody-drug Conjugate (ADC) market, it is essential that CMO’s have robust manufacturing platforms to ensure successful transfer to GMP production.
Single-Use Technologies provide many advantages, including improved safety, lower costs and greater flexibility. This webinar will outline the advantages of a Single Use Platform and give a case study on how it can be used to manufacture ADC projects.
In this webinar, you will learn:
● How single-use technologies can provide benefits for ADC manufacturing
● Why a solid manufacturing platform is crucial for a successful transfer to GMP production
● How a case study demonstrates the advantages of single-use equipment in a scale up to GMP production
Accelerating cell therapy manufacturing through robust process development - ...MilliporeSigma
Watch the webinar here: https://bit.ly/2WFoinn
Industry trends in regenerative medicine highlight a critical need for automated and closed manufacturing to support scalable production. With over 1,000 clinical trials underway worldwide utilizing the RM/AT designation, it's increasingly more important that successful clinical trials translate to marketable treatments. To ensure proper translation, manufacturing strategies must generate products that are effective, safe, consistent and help reduce costs. To achieve this goal, fit-for-purpose solutions are required.
This webinar presents an introduction to our fit-for-purpose cell therapy manufacturing solution, the ekko™ cell processing system. We will share process development strategies through case studies that support a variety of unit operation steps across cell types, including but not limited to, wash and concentration of T cells and aggregate processing of induced pluripotent cells.
The goal of our presentation is to share process development strategies for solutions that can be seamlessly translated and implemented for use in commercial production.
In this webinar, you will learn:
* Manufacturing trends for closed and automated cell therapy processes and requirements for industrialization of cell therapies
* Introduction to acoustic cell processing and how it works
* Process optimization with case studies across a variety of cell types and unit operations
Host Cell Protein Analysis by Mass Spectrometry | KBI BiopharmaKBI Biopharma
Host Cell Protein Analysis by Mass Spectrometry. Originally presented at the 2018 Sciex Users Meeting by Michael J Nold, Ph.D., Mass Spectrometry Core Facility at KBI Biopharma.
From Screening to QC: Development Considerations for Octet MethodsKBI Biopharma
The Octet is a powerful platform that can be used for rapid binding analysis of samples throughout development, stability testing and can be implemented or release of GMP material. For potency analysis of GMP materials, methods must demonstrate precision, accuracy, specificity and linearity across the range of specifications.
Watch the webinar now: http://bit.ly/scale-up-webinar
Flexibility and speed are key for the development of a new drug, from research to clinic and from clinic to market. Being able to produce a batch at the right time and at the right size is required to handle clinical trials in a fast and cost effective manner. For that purpose, a robust process is mandatory but its scalability makes a difference. During this session, we will describe our method to ensure efficient process tech transfer from a 3L to a 2000L bioreactor, straight forward. The knowledge generated during process development, as well as a specific model designed to keep the oxygen mass transfer coefficient (KLa) stable in any bioreactor, drive the success of such a challenge.
In this webinar, you will learn:
- How to modelize oxygen uptake in a bioreactor
- How to use this model and scale-up a process
- How to liaise with harvesting through clarification
High Productivity Membrane Chromatography: Enabling the Next Generation Biopr...Merck Life Sciences
A novel single-use chromatography platform enabling cost-efficient manufacturing to support the growing global demand for affordable biologics.
A new single-use (per batch) chromatography platform employs traditional, proven chemistries in an inventive hydrogel polymer membrane format that enables the next generation bioprocessing paradigm. The experimental Protein A membrane, featuring a 10-fold improvement in productivity over resin columns and high selectivity (i.e. 3 LRV HCP), is combined with high performance membranes with mixed mode and ion exchange modalities for a fully single-use membrane-based purification process. The membrane columns show protein capacities similar or superior to reference resins in bind and elute, and up to 7 LRV clearance of MVM at 20kg/L in flow through mode. A membrane-based process allows a holistic process strategy involving small footprint, high throughput processing by means of a rapid multi-cycling capture step (up to 100 cycles per batch) and high capacity flow through polishing. This single-use (per batch) platform results in simple, compact, flexible, yet robust and safe downstream operations for cost-efficient manufacturing to support the growing demand for affordable biologics.
In this webinar, you will learn about:
• Advantages of a fully single-use membrane-based purification processes
• High capacity flow through polishing with an inventive membrane adsorber combining the best of resins (DBC) and membranes (30x of flow rate)
Scalability of a Single-Use Bioreactor Platform for Biopharmaceutical Manufac...KBI Biopharma
Presented at PepTalk 2017: San Diego, CA
Niket Bubna, Principal Scientist, Process Development, KBI Biopharma
Single-use Technologies And Continuous Processing
(Advancing Bioprocessing Through Technological Innovation)
Risk Mitigation Strategies For Single-use Technologies
Integrated utilization of high-throughput bioreactors & high-throughput analy...KBI Biopharma
There is a strong impetus towards rapidly advancing an increasing number of novel biotherapeutics to clinical trials. However, development of cell culture processes is labor intensive and time consuming. KBI focuses on a high throughput process development (HTPD) approach using high-throughput miniaturized bioreactors and high throughput analytics that generate growth, productivity and product quality data that match those seen with classical systems. This approach enables a significant reduction in the cell culture process development timeline and costs for investigational biopharmaceuticals to reach the clinic.
Presentation at BPI West by Abhinav A. Shukla, Ph.D. Senior Vice President Development & Manufacturing KBI Biopharma, Durham NC, February 27 – March 2, 2017, Platforms for mAb Commercialization
A key bottleneck for mammalian cell culture productivity is the extended duration of the process with inoculum seed train and production culture stretching between 4-6 weeks in duration. Introducing flexibility in scheduling and execution of cell culture manufacturing campaigns with via a reduction in process duration can be a key strategy for maximizing facility utilization and facilitating the progression of multiple therapeutics to clinical trials. In this work, we investigated the initiation of CHO cell culture production runs using seed cultures cryopreserved in large disposable bags.
Optimization of Glycosyation & Charge Distribution Through Culture Parameters...KBI Biopharma
Introduction – KBI workflow
•Case study 1 – PAT approach to meet charge species target
•Case study 2 – Product quality toolbox
•Case study 3 – Impact of Cu2+ on product quality
•Conclusions
Learn more about the Valitacell fluorescent polarisation based IgG quantification assay 'ValitaTITER' and about our novel ChemStress fingerprinting assay for cell line development. For more information about our products and pricing, please contact info@valitacell.com
The demand for the fast and robust development of manufacturing cell lines is ever growing, with an increasing number of therapeutic proteins in development. To fulfill these needs, Celonic engineered the cell line kit CHOvolution™, which equips users with everything required for the development of mammalian cell lines and provides an integrated support system for assistance.
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.emdmillipore.com/webinars
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...Merck Life Sciences
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.merckmillipore.com/webinars
Scalability of Cell Culture Processes in Single-use Bioreactors using Differe...KBI Biopharma
Niket Bubna, Cameron T. Phillips, Sigma S. Mostafa and AbhinavA. Shukla. KBI Biopharma, Durham, NC
253rd ACS National Meeting & Exposition
April 2-6, 2017 • San Francisco, CA
#acsSanFran • www.acs.org/SanFran2017
Adherent Lentivirus Suspension Production & Manufacturing.pptxGenScript ProBio
GenScript ProBio is the world's leading biotech company founded in 2002 in New Jersey USA. We at GenScript ProBio provide various solutions based on gene synthesis technology including lentivirus manufacturing, CAR-T IND filing, plasmid manufacturing & production, and many more.
The Magic™ High-throughput Antibody Production Service of Creative Biolabs starts with a specific sequence of a whole antibody or variable region, ends with multiple particular characteristics, such as the mutation requirements, specific antibody type, host selection, modification requirement, etc. Eventually, we offer up to several micrograms of target antibodies with 95 % purity at least through our creative quality control system. Meanwhile, we provide the detailed lab report of the whole procedure and optimized parameters. No doubt, the Magic™ High-throughput Antibody Production Service is destined to stand on the cutting-edge of antibody production for pushing the frontline forward. If you have any question, contact us now for more information.
The incredible Magic™ High-throughput Antibody Production Service of Creative Biolabs has adopted all the mature technologies relating to the high-throughput antibody production. Meanwhile, our diligent scientists are still vigilant to any emerging novel concepts and strategies for perfecting our superior antibody screen and expression service harboring the most excellent high-throughput capacity.
Demonstrating Process Scalability with Robust and Turnkey PlatformsMerck Life Sciences
Upstream bioreactor process development and scale-up is a time-consuming step in recombinant protein production. Variability in the recombinant cell, cell culture media and bioreactor vessel contributes to the number of studies required to obtain a stable, productive, and scalable process. In our laboratory, we set out to develop a robust, turnkey platform that includes DNA vectors, modified cell lines, chemically defined cell culture media and single-use bioreactors. Here we demonstrate process development and scale-up of a recombinant CHOZN® GS clone in EX-CELL® Advanced™ cell culture media from small-scale flasks through bench-scale bioreactors and up to 50 L pilot scale bioreactor systems. While challenges typical of process scale-up were present, we consistently achieved the desired level of process performance across the different scales with minimal process optimization due to the robustness of the complete solution.
In this webinar, you will learn about:
- Demonstrating the process development and scale-up of a recombinant CHOZN® GS clone in EX-CELL® Advanced™ cell culture media from small-scale up to 50 L pilot scale.
- Achieving the desired level of process performance across the different scales.
Demonstrating Process Scalability with Robust and Turnkey PlatformsMilliporeSigma
Upstream bioreactor process development and scale-up is a time-consuming step in recombinant protein production. Variability in the recombinant cell, cell culture media and bioreactor vessel contributes to the number of studies required to obtain a stable, productive, and scalable process. In our laboratory, we set out to develop a robust, turnkey platform that includes DNA vectors, modified cell lines, chemically defined cell culture media and single-use bioreactors. Here we demonstrate process development and scale-up of a recombinant CHOZN® GS clone in EX-CELL® Advanced™ cell culture media from small-scale flasks through bench-scale bioreactors and up to 50 L pilot scale bioreactor systems. While challenges typical of process scale-up were present, we consistently achieved the desired level of process performance across the different scales with minimal process optimization due to the robustness of the complete solution.
In this webinar, you will learn about:
- Demonstrating the process development and scale-up of a recombinant CHOZN® GS clone in EX-CELL® Advanced™ cell culture media from small-scale up to 50 L pilot scale.
- Achieving the desired level of process performance across the different scales.
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
Webinar: Novel Perfusion Filter and Controller for N-1 ApplicationMerck Life Sciences
Participate in the interactive webinar now: http://bit.ly/SeedTrainPt2
The industry focus on process intensification is driving an increase in adoption of perfusion within the seed train. In an effort to deliver on the need for a robust solution we have developed a filter/controller duo that makes process intensification a reality!
Explore our webinar library: www.merckmillipore.com/webinars
Webinar: Novel Perfusion Filter and Controller for N-1 ApplicationMilliporeSigma
Participate in the interactive webinar now: http://bit.ly/SeedTrainPt2
The industry focus on process intensification is driving an increase in adoption of perfusion within the seed train. In an effort to deliver on the need for a robust solution we have developed a filter/controller duo that makes process intensification a reality!
Explore our webinar library: www.emdmillipore.com/webinars
Accelerate Delivery of High Producing Cell LinesMilliporeSigma
Watch the interactive recording here: https://bit.ly/30FTDG0
The quest for a viable upstream process relies on generation of a cell line expressing the protein of interest. Unfortunately, the search for the best-producing clone is often compared with looking for a needle in a haystack. Making this more challenging is the pressure to get it right the first time, quickly and while mitigating risk and costs.
Although a lot of efforts are made on the clonal selection, there is often few to none optimization done on the expression cassette, including promoter and enhancer selection, or signal peptide. The statistical approach on how many clones should be screened to get to a good producer is often overlooked as well.
We combined a new generation of promoters and enhancers to improve strategies on pool and mini pool screening with both CHO-K1 and our own CHOZN® GS which helped deliver high-producing clones in an accelerated timeline. In addition, we are able to begin process development in parallel with cell line development, further reducing timelines.
In this webinar, you will learn:
* How the strategy approach can help reducing the overall timeline of cell line generation
* How we have expanded our platform by designing a completely new vector/cell/process template
* How we have worked on promoters, enhancers, pool/mini-pool approach as well as on timelines from DNA to clone
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
2. Cellca is a leading provider of Cell Line Development Services allowing customers easy open access to a cost effective reliable
technology platform consistently delivering well characterised stable research clones from DNA to Research Cell Bank (RCB) in 4
months with titres upwards of 3.0 g/L in an easily scalable fed batch process.
Key Benefits
Speed
`` From DNA to high-titre RCB in 4 months. Save up to 3 months by omitting the need for scalability studies.
Track record
`` More than 70 successfully completed projects using the Cellca CHO Expression Platform.
Performance
`` 95% of our developed cell lines deliver protein titres exceeding 3 g/L in a 12-14 day standard fed-batch process.
Scalability
`` Processes can be easily transferred and scaled-up to a range of bioreactors up to 2000 L.
Customer focus
`` Committed project teams and dedicated client manager’s make it their purpose to deliver service excellence and
meet our client’s requirements.
Cellca CHO Expression Platform
Key Components
Host Cell Line
• CHO DG44
• Growth in suspension
• Long-term stability
• Fully documented history
Expression Vector
• DHFR system with high
selection stringency
• Optimal signal peptide
• Freedom to operate
Media System
• Chemically defined
• Free of animal components
• Free of proteins & peptones
• Optimised for Cellca cell lines
Upstream Process Design
• Robust
• Easy to scale
• Proven performance in
various bioreactor systems
Transfection &
Pool GenerationVector Cloning Single Cell Cloning Clone Evaluation RCB Preparation
From DNA to RCB in 4 months
3. Products
`` mAbs (lgG1, IgG4, IgG2)
`` Fc-fusion proteins
`` Fab-related products
`` Bispecific antibodies
`` Biosimilars
Scalability and Robustness
Now Available
Progress your product development cycle by utilizing Sartorius Stedim BioOutsource’s GMP cell bank manufacturing service.
Refer to our MCB brochure for more info.
Scalability from shake flask to 2000 L with minimal process development
Cellca Track Record (Oct 2017)
2 g/L 3 g/L 4 g/L 5 g/L 6 g/L
Pre-clinic &
Phase 1
10 21 13 10 9
Phase 2 1 1 - - 1
Phase 3 1 - - - -
Market Approval - - - - -
200 L
BIOSTAT® STR
2000 L
BIOSTAT® STR
UNIVESSEL 5 L
BIOSTAT® STR
4. Laupheim
Sartorius Stedim Cellca
Erwin-Rentschler-Str. 21
88471 Laupheim, Germany
Phone: +49.7392.96648.10 | Fax: +49.7392.96648.29
Glasgow
Sartorius Stedim BioOutsource
1 Technology Terrace, Todd Campus,
West of Scotland Science Park,
Glasgow, G20 0XA
Phone: +44.141.946.4222 | Fax: +44.141.948.1291
Göttingen
Sartorius Stedim Biotech
August-Spindler-Straße 11,
37079 Göttingen, Germany
Tel: +49.551.308.0 | Fax: +49.551.308.3289
www.sartorius-stedim.com
Sartorius Stedim Cellca and BioOutsource Global Facilities
For further contacts, visit www.cellca.de and www.biooutsource.com
Laupheim, Germany
Göttingen, Germany
Glasgow, UK
www.cellca.de/
Specificationssubjecttochangewithoutnotice.PrintedintheEUonpaperbleachedwithoutchlorine.
PublicationNo.:S--1539-e160301·OrderNo.:85037-554-21·Ver.04/2017
