This document evaluates different manufacturing technologies for producing recombinant modified vaccinia virus Ankara (rMVA) vectors using the DF-1 chicken cell line. It discusses IDT Biologika's development sites in Dessau and Rockville that are approved for vaccine manufacturing. It also introduces the DF-1 cell line and four technology platforms (CEF, CellStak, fixed bed, microcarrier) that could be used for rMVA production. It provides process details and characterization results for rMVA production using the CellStak platform at small and larger scales. It also presents a proof of concept study comparing the Pall fixed bed and Univercells fixed bed technologies. The document demonstrates IDT Biologika's expertise in rMVA
This document contains a soccer quiz with multiple choice questions about players, events, and facts related to the FIFA World Cup. It includes 20 questions about various World Cup stats and trivia, such as players who have scored hat tricks or the first goal in multiple World Cup tournaments. The questions are identified only by number and players or events are only identified in the answers.
This quiz covers a wide range of topics testing knowledge of popular culture, history, and current events from around the world. Questions include identifying singers, movies, people, places, events, and other trivia. The format tests recognition and recall of details rather than open-ended questions.
This document summarizes an audio visual quiz finals competition with the following key details:
- There were two rounds of trivia questions with 10 questions each and two written theme rounds.
- The first theme round involved identifying 5 Indian tributes to famous film/TV themes for points.
- Subsequent rounds included identifying visiting cards of famous people, answering questions about current events and historic figures, and participating in interactive trivia games for points.
- The competition featured a variety of audio, visual and written questions testing general knowledge on topics like science, history, and pop culture.
K Circle Weekly Quiz - Jan 9 , 2016 by Lucky KaulLucky Kaul
The document provides information about an upcoming quiz being hosted by Lucky Kaul. It includes:
- 5 rounds with a total of 24 questions plus a long visual connect round
- Details on the different question formats including written, infinite bounce/pounce, and visual connect
- A request for people to be gentle as it is the host's first quiz
- An overview of the first round involving internet trends from the past year
This quiz was hosted by Balaji Subramanian at Interrobang 2016, the 3rd Edition of the NALSAR Quiz Fest earlier this year. It was also rerun at the November 2016 Quiz of the Month at K-Circle, Hyderabad by Rama Subramanian.
Content by Balaji and members of Quizzing@NALSAR. Feedback/reviews would be appreciated, you can send it in to quizzing@nalsar.ac.in.
- The document contains rules and questions for a trivia competition involving 20 questions total. Questions 6, 8, 16, and 20 are marked as "star questions" to be used to resolve any ties. The top 6 teams will advance to the finals. Participants are instructed to avoid googling answers or engaging in betting or fixing. The quizmaster's decision is final.
This document contains a sports quiz with multiple choice questions about various sports events and personalities. It includes 4 sections - Sports Quiz, Connect, Find Out, and Reasoning Round - with a total of 24 questions testing knowledge about cricket, football, field hockey, the Olympics and more. The questions cover topics like famous matches, player achievements and controversies from different eras in order to test the reader's sports trivia knowledge.
This document contains a soccer quiz with multiple choice questions about players, events, and facts related to the FIFA World Cup. It includes 20 questions about various World Cup stats and trivia, such as players who have scored hat tricks or the first goal in multiple World Cup tournaments. The questions are identified only by number and players or events are only identified in the answers.
This quiz covers a wide range of topics testing knowledge of popular culture, history, and current events from around the world. Questions include identifying singers, movies, people, places, events, and other trivia. The format tests recognition and recall of details rather than open-ended questions.
This document summarizes an audio visual quiz finals competition with the following key details:
- There were two rounds of trivia questions with 10 questions each and two written theme rounds.
- The first theme round involved identifying 5 Indian tributes to famous film/TV themes for points.
- Subsequent rounds included identifying visiting cards of famous people, answering questions about current events and historic figures, and participating in interactive trivia games for points.
- The competition featured a variety of audio, visual and written questions testing general knowledge on topics like science, history, and pop culture.
K Circle Weekly Quiz - Jan 9 , 2016 by Lucky KaulLucky Kaul
The document provides information about an upcoming quiz being hosted by Lucky Kaul. It includes:
- 5 rounds with a total of 24 questions plus a long visual connect round
- Details on the different question formats including written, infinite bounce/pounce, and visual connect
- A request for people to be gentle as it is the host's first quiz
- An overview of the first round involving internet trends from the past year
This quiz was hosted by Balaji Subramanian at Interrobang 2016, the 3rd Edition of the NALSAR Quiz Fest earlier this year. It was also rerun at the November 2016 Quiz of the Month at K-Circle, Hyderabad by Rama Subramanian.
Content by Balaji and members of Quizzing@NALSAR. Feedback/reviews would be appreciated, you can send it in to quizzing@nalsar.ac.in.
- The document contains rules and questions for a trivia competition involving 20 questions total. Questions 6, 8, 16, and 20 are marked as "star questions" to be used to resolve any ties. The top 6 teams will advance to the finals. Participants are instructed to avoid googling answers or engaging in betting or fixing. The quizmaster's decision is final.
This document contains a sports quiz with multiple choice questions about various sports events and personalities. It includes 4 sections - Sports Quiz, Connect, Find Out, and Reasoning Round - with a total of 24 questions testing knowledge about cricket, football, field hockey, the Olympics and more. The questions cover topics like famous matches, player achievements and controversies from different eras in order to test the reader's sports trivia knowledge.
Interrobang 2018 - Attorney General Quiz (with answers)AnubhavSachdeva2
A written quiz with a legal flavour to each question, that I hosted with Balaji Subramaniam at Interrobang 2018, NALSAR's annual QuizFest. The top score was 21/35.
Prelims with Answers SPENT Quiz (Sports and Entertainment Quiz) Roobaroo'15Atharva
This document contains 25 sports and entertainment trivia questions with answers provided below each question. The questions cover topics like famous artists who died at age 27, actors and their unique skills, biographies of athletes, details about sporting events and rivalries, auto racing history, movie references, song lyrics, and more. The answers identify people, teams, events, movies, songs, and other facts being referenced in the trivia questions.
The document describes an annual cricket quiz organized by Well Of Course, including details of the written and clock rounds. The written rounds involve identifying cricketers, incidents and answering questions based on audiovisual clips and pictures. The clock round involves answering 18 questions within the allotted time using a pounce system. Sample questions from both rounds are included covering topics like historic partnerships, player nicknames, controversies and more. Exchange sheets with answers are also provided.
This document provides details of the MegaWhats 2016 semi final 1 tournament. It lists the 8 participating teams and details the format of the competition, which includes written questions, and "Infinite Pounce" and "Infinite Bounce" oral rounds to determine the top 4 teams that will qualify for the finals. It also provides 16 sample questions asked in the competition rounds.
25AUG2021_17OCT2021_Lazy_Compilation_Arun T PArun T P
The document discusses various trivia questions and their answers related to literature, history, science, and current events. It includes questions about literary prizes, art controversies, scientific discoveries, transportation innovations, and more. The questions are presented with clues, images, or additional context to aid in determining the right answer.
The document provides 10 questions in the Business section about topics like IKEA's new furniture collection, a UK steel tycoon's donation to Harvard University, and which two countries launched an "Asia-Africa growth corridor" counter to China's Belt and Road Initiative. It then provides 10 questions in the Sports section about topics in cricket, football, and the Olympics. Finally, it provides 10 questions in the India section about topics like the Victoria Memorial in Kolkata, forts in Rajasthan, and Indian independence leaders.
U-25 Science-Business-Technology Quiz by Titash Banerjea and Kunal Mandal at QRIOSIY 2019, Jadavpur University, Kolkata.
The prelims cut-off was 11.5.
The results were:
FIRST - Piyush Kedia, Samanway Banerjee, Christian Cage
SECOND - Abhimanyu Bharade, Kaustav Mandal, Rupam Kumar Dubey
THIRD - Gokul S, Aditya Narayan Sen, Vivek Bhagat
This document contains the rules for an online quiz competition between two teams. It states there will be 32 questions answered through buzzers, with +100 points for a correct answer and -100 for an incorrect one. Only one team can claim the points for a correct answer. The sequence of answers will be based on who buzzes in, with the second to last team having the option to pass. The quiz master's decision is final.
I apologize, upon reviewing the document again I do not see any questions asked about gymnastics moves or their names. Could you please rephrase or clarify the question?
CLR (Cricket is our Life and Religion) ICC ODI Cricket World Cup Quiz 2023Resham Das
A set on the ODI World Cup cricket history, from the 2023 ICC ODI World Cup Quiz competition at CLR (Cricket is our Life and Religion) community.
It carries 4 rounds of cricket quizzing, that covers many aspects of cricket, the ascent of ODI (One Day International) World Cup and the progress of different cricket-playing nations around the world.
Here is a summary of the four rounds in this quiz set:-
1) Semifinalists and Finalists
2) World Cup Finals
3) Stats and Records
4) Rapid Fire
Tease your cricketing brain with this set of 80 questions that covers the ODI World Cup cricket dynamics, beginning with the 1975 Prudential World Cup hosted by England, till the 2023 ICC World Cup hosted by India, and so on.
This is the set of questions for the Heritage Quiz Festival (HQF) 2016. HQF is the annual quiz festival organised by Atmadweep, the quiz and debate club of Heritage Institute of Technology.
This is the set of questions for the prelims.
The document summarizes the rules and structure of the iQuest 9 quiz competition final round. It outlines 3 rounds of questions - a direct round with 6 questions worth varying points, a connect round with 8 buzzer questions, and a final buzzer round with 10 questions. Teams can earn points for correct answers and lose points for incorrect answers, depending on the round. Questions cover topics like identifying people, connecting concepts, and answering trivia. The rounds introduce increasing difficulty and point values for answering quiz questions on the buzzer.
This document outlines the rules and questions for a cricket quiz on the social media platform Reddit. It contains 20 multiple choice or fill-in-the-blank questions about cricket players, matches, controversies, and terminology. Questions 11-15 follow a specific theme that participants can earn additional points for guessing. The quiz includes safety slides between questions and covers topics throughout cricket history from the 1990s to present day.
Finals of the SpEnt Quiz that Balaji and I hosted at Revels, Manipal Institute of Technology's annual sports and cultural fest earlier this year. YouTube videos embedded.
Second Semi-Final of the MegaWhats national team quiz championship held as part of asKQAnce 2017 - KQA's 34th anniversary celebration. The quiz was won by We Are Like This (W)only from Bangalore.
The document provides questions and prompts for a quiz or game show. It includes questions on topics like science, inventions, history, and literature. Many questions refer to famous people and their accomplishments, including scientists like Einstein and discoveries they made. The format involves multiple choice or short answer responses.
Addressing the Challenge of Scalability in Viral VectorsMilliporeSigma
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
Interrobang 2018 - Attorney General Quiz (with answers)AnubhavSachdeva2
A written quiz with a legal flavour to each question, that I hosted with Balaji Subramaniam at Interrobang 2018, NALSAR's annual QuizFest. The top score was 21/35.
Prelims with Answers SPENT Quiz (Sports and Entertainment Quiz) Roobaroo'15Atharva
This document contains 25 sports and entertainment trivia questions with answers provided below each question. The questions cover topics like famous artists who died at age 27, actors and their unique skills, biographies of athletes, details about sporting events and rivalries, auto racing history, movie references, song lyrics, and more. The answers identify people, teams, events, movies, songs, and other facts being referenced in the trivia questions.
The document describes an annual cricket quiz organized by Well Of Course, including details of the written and clock rounds. The written rounds involve identifying cricketers, incidents and answering questions based on audiovisual clips and pictures. The clock round involves answering 18 questions within the allotted time using a pounce system. Sample questions from both rounds are included covering topics like historic partnerships, player nicknames, controversies and more. Exchange sheets with answers are also provided.
This document provides details of the MegaWhats 2016 semi final 1 tournament. It lists the 8 participating teams and details the format of the competition, which includes written questions, and "Infinite Pounce" and "Infinite Bounce" oral rounds to determine the top 4 teams that will qualify for the finals. It also provides 16 sample questions asked in the competition rounds.
25AUG2021_17OCT2021_Lazy_Compilation_Arun T PArun T P
The document discusses various trivia questions and their answers related to literature, history, science, and current events. It includes questions about literary prizes, art controversies, scientific discoveries, transportation innovations, and more. The questions are presented with clues, images, or additional context to aid in determining the right answer.
The document provides 10 questions in the Business section about topics like IKEA's new furniture collection, a UK steel tycoon's donation to Harvard University, and which two countries launched an "Asia-Africa growth corridor" counter to China's Belt and Road Initiative. It then provides 10 questions in the Sports section about topics in cricket, football, and the Olympics. Finally, it provides 10 questions in the India section about topics like the Victoria Memorial in Kolkata, forts in Rajasthan, and Indian independence leaders.
U-25 Science-Business-Technology Quiz by Titash Banerjea and Kunal Mandal at QRIOSIY 2019, Jadavpur University, Kolkata.
The prelims cut-off was 11.5.
The results were:
FIRST - Piyush Kedia, Samanway Banerjee, Christian Cage
SECOND - Abhimanyu Bharade, Kaustav Mandal, Rupam Kumar Dubey
THIRD - Gokul S, Aditya Narayan Sen, Vivek Bhagat
This document contains the rules for an online quiz competition between two teams. It states there will be 32 questions answered through buzzers, with +100 points for a correct answer and -100 for an incorrect one. Only one team can claim the points for a correct answer. The sequence of answers will be based on who buzzes in, with the second to last team having the option to pass. The quiz master's decision is final.
I apologize, upon reviewing the document again I do not see any questions asked about gymnastics moves or their names. Could you please rephrase or clarify the question?
CLR (Cricket is our Life and Religion) ICC ODI Cricket World Cup Quiz 2023Resham Das
A set on the ODI World Cup cricket history, from the 2023 ICC ODI World Cup Quiz competition at CLR (Cricket is our Life and Religion) community.
It carries 4 rounds of cricket quizzing, that covers many aspects of cricket, the ascent of ODI (One Day International) World Cup and the progress of different cricket-playing nations around the world.
Here is a summary of the four rounds in this quiz set:-
1) Semifinalists and Finalists
2) World Cup Finals
3) Stats and Records
4) Rapid Fire
Tease your cricketing brain with this set of 80 questions that covers the ODI World Cup cricket dynamics, beginning with the 1975 Prudential World Cup hosted by England, till the 2023 ICC World Cup hosted by India, and so on.
This is the set of questions for the Heritage Quiz Festival (HQF) 2016. HQF is the annual quiz festival organised by Atmadweep, the quiz and debate club of Heritage Institute of Technology.
This is the set of questions for the prelims.
The document summarizes the rules and structure of the iQuest 9 quiz competition final round. It outlines 3 rounds of questions - a direct round with 6 questions worth varying points, a connect round with 8 buzzer questions, and a final buzzer round with 10 questions. Teams can earn points for correct answers and lose points for incorrect answers, depending on the round. Questions cover topics like identifying people, connecting concepts, and answering trivia. The rounds introduce increasing difficulty and point values for answering quiz questions on the buzzer.
This document outlines the rules and questions for a cricket quiz on the social media platform Reddit. It contains 20 multiple choice or fill-in-the-blank questions about cricket players, matches, controversies, and terminology. Questions 11-15 follow a specific theme that participants can earn additional points for guessing. The quiz includes safety slides between questions and covers topics throughout cricket history from the 1990s to present day.
Finals of the SpEnt Quiz that Balaji and I hosted at Revels, Manipal Institute of Technology's annual sports and cultural fest earlier this year. YouTube videos embedded.
Second Semi-Final of the MegaWhats national team quiz championship held as part of asKQAnce 2017 - KQA's 34th anniversary celebration. The quiz was won by We Are Like This (W)only from Bangalore.
The document provides questions and prompts for a quiz or game show. It includes questions on topics like science, inventions, history, and literature. Many questions refer to famous people and their accomplishments, including scientists like Einstein and discoveries they made. The format involves multiple choice or short answer responses.
Addressing the Challenge of Scalability in Viral VectorsMilliporeSigma
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
E. Van den Born - New vaccine technology: Hopes and fearsEuFMD
Session IV
The application of RNA and vector vaccines to combat the COVID-19 pandemic has shown that these and other new vaccine technologies have great potential to combat (emerging) diseases, but has also fuelled the discussion around their safety. Was the fear and scepticism among the global public of taking a COVID-19 vaccine realistic? In this talk I will briefly highlight the different vaccine technologies and some of their pros and cons. New vaccine technologies include antigens and antigen delivery methods, administration methods, and adjuvants. The impact of new vaccine technologies on large scale manufacturing, the cost of goods, and the product registration process will be address as well, with an emphasis on veterinary applications.
Dyadic International presented on their C1 vaccine technology platform. C1 is a genetically engineered fungal strain that can rapidly produce high yields of proteins for vaccines and biologics. C1 offers advantages over other platforms like CHO cells, including lower production costs, faster production timelines, and the ability to produce various vaccine modalities. Dyadic discussed their rapid strain development process, high productivity data for vaccine antigens, and plans to initiate a Phase 1 clinical trial of their C1-produced COVID-19 booster vaccine called DYAI-100.
Developing a single use adenovirus-vectored vaccine process through public-pr...Merck Life Sciences
This work highlights the importance of collaborations to accelerate vaccine process development and manufacturing under the constant pressure of emerging diseases and the growing need of global immunizations.
We are collaborating with the Jenner Institute of the University of Oxford to advance the development of a rapid, scalable and GMP compliant process for simian adenoviruses used as vector for vaccines such as Rabies and emerging threats like Zika and Ebola. This webinar will describe the transition from a labor and time intensive process development to one utilizing a maximum of disposable technologies such as single use bioreactors and filtration technologies, using the rabies vaccine as a first candidate. We will highlight the challenges and their corresponding solutions that in the end created a template that can be used for different types of adenoviral vectors-based vaccines manufacturing.
In this webinar, you will learn:
- The challenges of creating a rapid and scalable process for Adenovirus vector manufacturing.
- The solutions that overcame those challenges.
- How public-private collaborations can accelerate vaccine process development.
Developing a single use adenovirus-vectored vaccine process through public-pr...MilliporeSigma
This work highlights the importance of collaborations to accelerate vaccine process development and manufacturing under the constant pressure of emerging diseases and the growing need of global immunizations.
We are collaborating with the Jenner Institute of the University of Oxford to advance the development of a rapid, scalable and GMP compliant process for simian adenoviruses used as vector for vaccines such as Rabies and emerging threats like Zika and Ebola. This webinar will describe the transition from a labor and time intensive process development to one utilizing a maximum of disposable technologies such as single use bioreactors and filtration technologies, using the rabies vaccine as a first candidate. We will highlight the challenges and their corresponding solutions that in the end created a template that can be used for different types of adenoviral vectors-based vaccines manufacturing.
In this webinar, you will learn:
- The challenges of creating a rapid and scalable process for Adenovirus vector manufacturing.
- The solutions that overcame those challenges.
- How public-private collaborations can accelerate vaccine process development.
HOW MERCK CONTINUES TO EXPLORE SPEEDING VACCINE DEVELOPMENT TIMELINESiQHub
Merck presented on their efforts to rapidly develop vaccines through platform technologies and process optimizations. They discussed leveraging existing vaccine platforms and manufacturing processes to speed development timelines. For Ebola, they were able to produce over 750,000 doses within 9 months. For their COVID vaccine, they advanced from clone selection to phase 1 ready in 6 months. They also summarized their rapid development of a Sudan vaccine within 6 weeks through partnerships and applying lessons from other vaccine programs. Merck highlighted the importance of regulatory alignment, analytical capabilities, manufacturing flexibility and cross-functional partnerships to enable emergency response timelines.
Developing a Scalable Upstream Bioreactor Process for Lentiviral Vector Produ...MilliporeSigma
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
Developing a Scalable Upstream Bioreactor Process for Lentiviral Vector Produ...Merck Life Sciences
This document describes the development of a scalable upstream bioreactor process for lentiviral vector production using suspension cell culture. The goals were to design a manufacturing-friendly process that supports commercialization. A 50L bioreactor process was developed using a chemically-defined medium and HEK293T cells optimized for suspension growth. The process was demonstrated to be scalable through geometric similarity across bioreactor sizes from 3L to 2000L. This template process provides benefits like speed to patients, reliability, robustness, and efficiency for lentiviral vector manufacturing.
Western Blot Assessment of Polyclonal Anti-Host Cell Protein Antibody ProductionCovance
BEBPA HCP 2019 -- The most critical part of developing an ELISA for measuring Host Cell Protein (HCP) impurities in Biotherapeutics is generation of specific antibodies with appropriate recognition of the total population of HCPs potentially present in the product. The generation of the antiserum is dependent upon the sum of the individual biological responses (i.e., antibodies) of multiple animals to the antigen. Response is monitored throughout the program qualitatively by 1D (one dimension) Western Blot and adjustments are made to the antigen (immunogen) as needed to yield the broadest antigen recognition. Ultimately, the highest quality antisera from multiple animals are pooled. The quality of the final product is demonstrated through evaluation of coverage which is typically by 2D (two dimension) Western Blot or more recently by mass spectrometry. The BioCMC Group at Covance was tasked with development of a process capable of supporting this type of assessment. This capability will be illustrated through discussion of a typical antibody reagent production program.
Upstream Viral Safety – Protect your bioreactor with Virus FiltrationMilliporeSigma
This poster summarizes the performance of a filter specifically developed for virus removal from chemically defined cell culture media. The filter removes high levels of virus, mycoplasma and bacteria without impacting cell growth, antibody titer, or protein quality. The filter has robust performance over a broad range of conditions offering an effective, easy to implement solution for media treatment.
The document describes a biosensor called BREATHSAFE® for detecting H1N1 infections. It uses anti-hemagglutinin and anti-neuraminidase protein fragments immobilized on a glass slide as bioreceptors to detect the H1N1 viral proteins hemagglutinin and neuraminidase in respiratory secretions. When the viral proteins bind to the bioreceptors, secondary antibodies tagged with fluorophores bind, and fluorescence is excited and detected with a CCD camera, allowing for diagnosis. The sensor hardware will be inexpensive to manufacture and the disposable membranes will generate continuous revenue.
Exploring Intensified Seed Train Through Advancements in Perfusion Processing...Merck Life Sciences
This poster explores key elements of bioreactor design and automation strategies that enable successful implementation of seed train intensification via perfusion:
- Sparger performance characterization
- Cell retention device connection
- Evaluation of the Hamiltion® Incyte viable cell density (or permittivity) sensor
- Cell culture case studies
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
This document discusses Gumboro disease (Infectious Bursal Disease, IBD) and IBD vaccines. It provides information on when to apply field vaccination, the benefits of CEVAC IBD L vaccine, and comparisons of CEVAC IBD L to other vaccines. CEVAC IBD L uses the original Winterfield 2512 vaccine strain and has benefits such as quick immune response, spreading ability to unvaccinated birds, and guaranteed immunocompetence. Field trials found CEVAC IBD L provided better performance, lower mortality, and higher profits compared to competitor vaccines.
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
Platform Technologies to Accelerate Novel Vaccine Development and ManufacturingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3jmLYHu
State-of-the-art vaccine technologies are transforming vaccine development, and solutions for fast and reliable production are needed.
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platform.
In this webinar, you will learn:
• Benefits of platform technologies in vaccine development
• Key considerations when deciding between platforms
• Vaccine pipeline analysis and selected case studies
Presented by:
David Loong, Ph.D, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Josephine Cheng, Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy
This document summarizes a single-use platform for purifying adenovirus at scale. The platform uses disposable filters, cassettes, and membrane adsorbers to purify adenovirus from cell culture harvest in one day. Key steps include clarification with a depth filter, concentration/diafiltration with ultrafiltration cassettes, primary purification on a Q membrane adsorber, polishing with an STIC membrane to remove DNA, and final concentration/buffer exchange. The platform achieved 55% overall yield while meeting targets for host cell protein, DNA, and endonuclease concentration in the final product. It provides a standardized process that can be easily scaled up and reduces development time for new viral vaccine products
Plasmid Manufacturing Service from GenScript ProBioGenScript ProBio
GenScript ProBio offers the best Plasmid Manufacturing Service and employs a GMP-compliant plasmid production process that allows customers to replicate DNA used in experiments with minimal additional effort. By employing this process, Genscript can provide plasmids produced at the highest quality standards. For more information, visit our website. https://www.genscriptprobio.com/gct-proplasmid.html
This document summarizes a seminar presentation on the production of DNA vaccines. It begins by discussing the importance of vaccines in addressing infectious diseases and problems with traditional vaccines. It then covers topics like the advantages of DNA vaccines over recombinant protein vaccines, designing plasmid DNA constructs for vaccines, antigen expression systems, successful DNA vaccines to date, delivery methods like needle-free injection and microspheres, and the use of adjuvants to enhance vaccine activity.
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COMPARISON OF 3 PRODUCTION SYSTEMS FOR VACCINE MANUFACTURING
1. Evaluation of Different Manufacturing Technologies
for Manufacturing of rMVA Vectors on DF-1 Cell Line
Sabrina Pelz, 15-09-2022
2. 2
Introduction to IDT Biologika
CDMO Development Sites
IDT Biologika
Dessau (Germany)
Manufacturing License and
GMP Certificate granted by
the Saxony-Anhalt state
administrative office.
IDT Biologika
Rockville (USA)
Manufacturing according US FDA
regulations for development and
manufacturing of phase I/II
investigational medicinal products.
Approved by US CDC
EHS/ ISO-certified.
IDT Biologika / ZENIT
Magdeburg (Germany)
Approved for development of
biological products according to
biosafety and GMO regulations for
BSL 2.
Process development for viral vector
and cell and gene therapy
technologies.
Owner
Klocke Holding GmbH
Carsten Klocke and Stefan Klocke
(CEOs)
1,900
employees in
2020
€ 293 m
turnover in 2021
€ 550 m
invested by IDT
since 1993,
Vaccine Technology Summit 2022
3. 3
Modified Vaccinia Virus Ankara Vaccines
MVA has been used as a vaccine vector in many clinical trials (e.g. Malaria, Tuberculosis, HBV,
HIV, Smallpox, Filoviruses, Mers CoV, SARS); the vaccines are well tolerated in those clinical
studies.
MVA has been tested in several ‘prime-boost’ regimens with high immunogenicity.
Both humoral and cell-mediated responses have been induced by vaccination.
Smallpox (Bavaria Nordic) and Ebola (Janssen) vaccines are approved MVA based vaccines.
IDT started MVA vector production in 1997
Major published projects with Oxford University, Bavarian Nordic, Geovax and Ludwig
Maximilian University Munich, CEPI
IDT evaluated and developed several technologies and scales for manufacturing of rec. MVA
Major achievement – High resolution large scale DSP technology for purification of IMV virus
particles
Vaccinia- 4 virus configurations
Ref: Journal of General Virology
(2002), 83, 2915-2931
Vaccine Technology Summit 2022
4. 4
Vaccine Technology Summit 2022
DF-1 Chicken Cell Line
Inventors: Douglas N. Foster; Linda K. Foster
UMNSAH/DF-1 ATCC® CRL-12203™ / continuous Chicken Embryo Fibroblasts cell line /
Origin: East Lansing Chicken Line (ELL-0)
Chicken cell substrate, none tumorigenic
- genetic stability for CEF adapted vaccine viruses
- Adherent cell line, spontaneously immortalized, not transformed
- Free of endogenous retroviral activity
- Permissive for a range of avian viruses, Vaccinia viruses, Morbilliviruses, VSV ,
Orthomyxoviruses and …
Current Status
- Exclusive license from Minnesota State University
- Clone purified
- Qualified according Pharm. Eu. Cell bank (MCS; WCS; EoP), none tumorigenic
- Phase 1, IND for Phase 2 submitted, Phase 3 and PPQ ready
DF-1, 72h p. seeding
5. 5
Vaccine Technology Summit 2022
Technology Platforms for rMVA-X Production
1. CEF Technology
2. CellStak Technology
3. Fixed Bed Technology
4. Micorcarrier Technology
With respect to the size of MVA virus a
sterile filtration (0.2µm) is not feasible
Aseptic processing is mandatory over
complete production process
Aseptic process validation is a
regulatory requirement independent
from the clinical phase
All product contact materials have to be
sterile with a validated of SAL10-6
1 2
3 4
Adherent DF-1 Cell Line
6. 6
Vaccine Technology Summit 2022
Days 15-21
Days 3
Days 1+1
Hold time
at -80C
Hold time
at 2-8C
Process Time
DF-1_MVA-X CellStack Platform
Generic Process Flow CS10/CS40
7. 7
Fast Track Upscale Approach between CTM PhaseⅠ CT and CTM PhaseⅡ CT
Process parameter CTM PhaseⅠCT CTM PhaseⅡCT Comment
Cell cultivation systems 20 CS 10 16 CS 40 Scale up
Cell cultivation surface 12.7 m2 40.7 m2 Scale up
Virus harvest / cell lysis 1 virus harvest 1 virus harvest divided
into 2 sub-batches
Scale up
Purification of the DS One harvest is purified
in 1 TFF rig by 2 consecutive TFF
processes
Each sub-batch is purified in 1
separate TFF rig by 2 consecutive
TFF processes
Scale up
Formulation of the DS batch 1 harvest is formulated as 1 DS
batch
Each separate purified sub-batch
(ca. 3300 ml) is pooled and
formulated as one DS batch
Scale up
Target volume of
concentrated and purified
final DS batch
1200 ml 6600 ml Scale up
DP filling as single dose
presentation in 2 R vials
Filling of 2 R vials on aseptic RABS
filling line 4 (IDT Biologika)
Fill volume 0.7 ml/vial
Filling of 2 R vials on aseptic
RABS filling line 3 (IDT Biologika)
Fill volume 0.7 ml/vial
Scale up
Both filling lines are validated for aseptic
performance. Line 4 operates with pre sterilized vials
at small scale; Line 3 operates with inline heat
sterilized / depyrogenized vials for large scale
DF-1_MVA-X CellStack Platform
Vaccine Technology Summit 2022
8. 8
Vaccine Technology Summit 2022
Visual analysis of cell monolayer,
relies on secondary infection
Subjective plaque counting
pfu/mL
Test duration: 4 to 14 days
Analysis on the single cell level during
primary infection
Objective counting of infected cells
IU/mL
Test duration: 48 h up to 4 days
Plaque Assay Flow Cytometrie
DF-1_MVA-X
New assay‘s required to accelerate up the process development
Plaque Assay Flow Cytometry
Assay
performance
Repeatability Similar repeatability
Intermediate
Precision
Less precise
( CV = 22.0 %)
Twice as precise
(CV = 11.0 %)
Accuracy
Worse recovery
(worst recovery =
166.2 %)
better recovery
(worst recovery = 112.3 %)
Linearity linear (R = 0.996) Strongly linear (R = 1.000)
Principle of
titer
determination
Manual plaque
counting
(operator
dependent)
Equipment-based
(operator independent)
Sensitivity
Highly sensitive –
depending on
chosen dilution
scheme
Quantification limit
3x105 IU/mL
Specificity
Non-specific or
specific
specific
9. 9
Viral yield
DF-1_MVA-X CellStack Platform
Different rMVA yield in similar viral titers on DF-1_MVA-X CellStak
platform
Viral titer USP and DSP remain constant during scale-up
CS40 platform: output 6L BDS up to 1.3E+07 IU/ cm² at 60 - 80%
recovery, whereas the main losses occurred during the second
diafiltration step
1,0E+06
1,0E+07
1,0E+08
1,0E+09
Lysate Clarific. DF1_R DF2_R BDS
Infectious
titer
[pfu/mL]
16xCS10
#001
16xCS10
#002
1,0E+06
1,0E+07
1,0E+08
1,0E+09
Lysate KF DF1_1R DF2_1_R DF1_2_R DF2_2_R BDS Pool
Infectious
titer
[IU/mL]
16CS40#001
16CS40#002
1,0E+06
1,0E+07
1,0E+08
1,0E+09
Lysate KF DF1_R DF2_R BDS
Infectious
titer
[IU/mL]
16xCS10
pfu
16xCS10
IU
TFF1 TFF2
TFF1 TFF2
Vaccine Technology Summit 2022
10. 10
BDS characterization – Impurity profile
Test of DS
Method
Unit
per
2E+08
IU/mL
Batch
#001
#002
#003
#004
#005
#006
#007
#008
MVA_X1 MVA_X2
CS10 CS40
Residual
BSA
ng <7.73 <11.1 <2.7 <3.9 2.2 <0.7 <0.5 <0.8
Total Protein µg 204 182 305 103 62 54 53 57
Endotoxins EU <1.7 <2.5 4 3.03 4.16 1.5 1.3 <0.6
Residual
DNAse
ng <4.3 <6.2 <6.8 <2.2 <1.2 <1.9 <1.3 <2.0
Residual
trypsin
IU <0.0002 <0.0002 <0.0003 <0.0001 <0.00005 <0.0001 <0.0001 <0.0001
Host Cell
DNA
(>127 bp)
ng 6.30 3.27 9.81 4.60 2.85 2.77 3.71 2.02
DF-1_ MVA-X on CS-10/CS40 platform
All QC assay are validated
Consistent impurity data for
each vector and during scale-up
Vaccine Technology Summit 2022
11. 11
Current Status
DF-1_MVA-X CellStack Platform
- Smale scale development focusing
general process understanding of
critical process parameter and process
attributes
- Yield and impurity optimization
- Process optimization focusing
processing times and process
complexity and costs
- Process transfer into production
including scale up from 4 x CS10 to 16 x
CS 10
- Second scale-up from 16 x CS10 to
16xCS using CS40 manipulation system
- Assay Validation
- Qualification of raw & starting materials
- FMEA based process characterization
IDT Biologika has Phase 3 ready rMVA-X cell stack platform with
exceptional high understanding of rMVA processing (Drug Substance
& Drug product manufacturing)
Vaccine Technology Summit 2022
12. 12
DF-1_MVA-X
1 Stirred Bioreactor – Microcarrier
Not very suitable – weak cell growth and low
yields
2 Fixed bed bioreactor - PALL
Excellent cell growth of DF-1 also at low seeding
density 3-5E+03 c/cm²
Viral yield 1 log below expectations
Further Upscaling Options
Vaccine Technology Summit 2022
13. 13
Smale scale Proof of concept (PoC) - Comparison PALL vs Univercells Fixed Bed Bioreactor
Smale scale POC
4 x 4 small scale runs with 2.4m² UniverCells bioreactor performed
Parameter as seeding density, media consumption and lysis condition investigated
Achievements
Same growth rates as in CS-10 an in iCellis nano achieved, Doubling time 30h
Achieved virus yields one log higher as in iCELLis nano, comparable to CS-10 platform
Virus yield PALL CS10 CS40 Univercells
rMVA_X1 5.0E+05 pfu/cm² 8.4E+06 pfu/cm² n/a n/a
rMVA_X2 n/a 2.4E+07 IU/cm²
3.0E+06 pfu/cm²
1.2E+07 IU/cm² 1.5E+07 IU/cm²
4.0E+06 pfu/cm²
UniverCells fixed bed technology seems a suitable alternative to e.g. cell stack systems for DF-1_MVA-X
POC show same comparable virus yield to CS-10
DF-1_MVA-X Fixed Bed Bioreactor Platform
Vaccine Technology Summit 2022
14. 14
Proof of Concept – 200 m² Scale-Up
Direct scale up into Univercells
200m² fixed bed Bioreactor to
gain a better understanding of
potential scale-up risks
Two 200m² PoC runs performed
First run direct transfer of small
scale process to 200m² system
Second run with adaptions
based on 1rst run learnings
DF-1_ MVA-X Fixed Bed Bioreactor Platform
Vaccine Technology Summit 2022
15. 15
Days 15-21
Days 2 - 4
Process Time
Proof of Concept – 200 m² Scale-Up, Generic Process Flow
DF-1_ MVA-X Fixed Bed Bioreactor Platform
With respect to process comparability, process steps and if applicable process parameter kept constant
during PoC.
Vaccine Technology Summit 2022
16. 16
Proof of Concept – 200 m² Scale-Up – BR Cell Growth Phase
DF-1_ MVA-X Fixed Bed Bioreactor Platform
Significant higher glucose metabolism at 200m²
Lactate metabolism slope between 2.4m² and
200m“ similar
Lactate concentration above 30mM at harvest
Based on carrier cell count accelerated growth rate
at 200m² scale
2.4m² scale cell growth 4 day delayed
Glucose
[mM]
Lactate
[mM]
200m²
2.4 m²
200m²
2.4 m²
Vaccine Technology Summit 2022
17. 17
Proof of Concept – 200 m² Scale-Up – Virus Production Phase
DF-1_ MVA-X Fixed Bed Bioreactor Platform
1,0E+05
1,0E+06
1,0E+07
1,0E+08
1,0E+09
IU/
ml
Batch 1
Batch 2
Same distribution of extracellular and
intercellular virus in FB bioreactor compared
to CellStack
Due to the higher titer per volume in the
lysate the particle amount is higher and may
influence the downstream process, but also is
allowing a reduced concentration factor
reaching similar target titers between the two
platforms
The current 200m² reactor design leads to 1/3
(10L) dead volume = Lost Product
Multiple lysis steps enable product recovery
but increase the downstream starting volume,
processing times and production cost
residual volume
Vaccine Technology Summit 2022
18. 18
Proof of Concept – 2.4m² scale – Virus Harvest Impurities
DF-1_ MVA-X Fixed Bed Bioreactor Platform
Batch
Titer
impurities
volume
Total protein BSA*
IU/ ml IU/ cm² mg/ml ng/ml ml
1 1.6E+08 1.1E+07 0.17 100 1600
2 1.1E+08 0.7E+07 0.14 92 1600
3 1.1E+08 0.7E+07 0.13 110 1600
4 1.6E+08 1.0E+07 0.22 107 1600
5 1.5E+08 1.0E+07 0.17 78 1600
Further development activities were performed to streamline the process achieving a robust and manufacturing suitable
USP process for recombinant MVA – production.
Current USP fixed-bed platform is reaching similar yields and impurity profiles (except BSA*) comparing to
established cell stack platform on a development scale
Currently wash regime procedure for the current process to reduce BSA* further as well as a serum-free medium for DF-
1 cell line in development
1
10
100
1000
10000
BSA
[ng/ml]
Vaccine Technology Summit 2022
19. 19
DF-1_ MVA-X
Vaccine Technology Summit 2022
Summary and Outlook
IDT Biologika has Phase 3 ready rMVA_X cell stack platform with exceptional high understanding of rMVA
processing (Drug Substance & Drug product manufacturing)
Different cell stack scales are implemented – 16 x CS10; 16 x CS40 with scale out possibility to 32 x CS40
Virus production including adherent cells in fixed-bed reactors provides advantages concerning scalability
compared to process in cell stacks.
Current platform in development to offer scaled-up process in fixed-bed systems for feasibility batches (R&D),
CTM production & commercialization , USP development data available from 2.4m² up to 200m² fixed-bed
DSP in development, current data sets are showing similar titer recoveries known from the cell stack process
IDT Biologika development and validated a FACS titer method for fast and robust titer determination for
development and product release purposes
DownStream process will be further optimized and stabilized, focusing higher BDS titers of > 1E+09 IU/mL
20. Thanks to my colleagues who asking questions, frequently improve the process,
solved and explained the unexpected, being not afraid to change the direction, did
all the analytical assay‘s and 10000 of viral titrations, transferred and scaled
processes, created batch records and fight in the lab if things does not happen as
planed …
Thanks for being a part of this team !!!