Dyadic is developing a new biological platform using the C1 gene expression system for vaccine and drug development and production. The C1 system uses the fungus C1 to produce enzymes and biologics at high levels. Dyadic has successfully used C1 to express various therapeutic proteins, antibodies, antigens, and virus-like particles. They are also working on improving the C1 system through protease deletion strains and glycoengineering to produce proteins with more human-like glycans. Dyadic believes the C1 system offers advantages over traditional systems for cost-effective and scalable production of biologics.
Producing Biologics with C1. The cell expression system of the futureDyadic
The C1 expression system has the potential to change the way in which both animal health and human biotech and pharmaceutical companies bring their biologic vaccines and drugs to market faster, in greater volumes, at lower cost, and with newer beneficial properties, and most importantly save lives.
WHY PATENT ARE IMPORTANT FOR DEVELOPMENT?| Understanding International Patent Classification (IPC)|World Intellectual Property Organization
-Patent protection means that the invention protected cannot be commercially made, used, distributed or sold without the consent of the patent owner or patentee
-Patents provide incentives to the individuals (Royalty)
Protection stimulates research, which results in technological development
-Patents promote innovation and dissemination of information
International Patent Classification
A61K: Preparations for Medical, Dental, or Toilet purposes
CO7G: Compounds of unknown constitution
C07K: Compounds of unknown constitution
E04G: Scaffolding; Forms; Shuttering; Building implement or other building aids
H04B: Transmission
H04L: Transmission of digital information
e.g.telegraphic communication
The IPC (International Patent Classification) is one of the most important tools available to people who want to search patent databases. It divides the world of technology up into over 70 000 categories. Whatever your technical field, you can use the IPC to zoom in to patent documents relevant to your field of work.
The IPC is a hierarchical system, with layers of increasing detail. Here is an example:
G Physics
G02 Optics
G02C Spectacles, sunglasses or goggles ...
G02C5 Construction of non-optical parts
G02C5/14 . Side members
G02C5/20 .. Adjustable, telescopic
Source: EPO
The conference will provide an interactive networking forum to both further develop and answer your queries through a vibrant exhibition room full of technology providers showcasing their technologies and other solutions, poster presentation sessions, expert led case study presentations, a high-level panel discussion, a round table discussion session, and interactive Q&A sessions from a 40-strong speaker faculty examining topics on 4 separate tracks outlined below.
Genentech, Novartis, Monsanto, THE REGENTS OF THE UNIVERSITY OF CALIFORNIA,
PIONEER HI-BRED INTERNATIONAL, INC., NOVARTIS AG, Monsanto Technology LLC,
ROCHE DIAGNOSTICS GMBH Top Patent filers & Patent recipients classified under the IPC C12.
Inventions in the field of Biochemistry & Genetic Engineering include-
Preparation of wine and other alcoholic beverages.
Preparation of Vinegar.
Apparatus for enzymology and microbiology.
Composition of microbes and enzymes.
Fermentation or enzyme-using processes to synthesise a desired chemical compound or composition or to separate optical isomers from a racemic mixture
Production of therapeutic glycoproteins -key players, innovators and industry...Dolcera Corporation
A Dolcera Report production about production of therapeutic proteins by glycosylation, major players and technological developments.
The report focuses on technology, industry and patent landscape of the concerned topic.
The Dolcera center of excellence finds about growth of a technology; competition- key players, innovators; gaps and opportunities in the technology and industry with the analyses of patents and trends as the core.
This presentation is a brief introduction to the detailed Dolcera Report on production of therapeutic proteins by glycosylation.
For more details and complete report contact info@dolcera.com
Producing Biologics with C1. The cell expression system of the futureDyadic
The C1 expression system has the potential to change the way in which both animal health and human biotech and pharmaceutical companies bring their biologic vaccines and drugs to market faster, in greater volumes, at lower cost, and with newer beneficial properties, and most importantly save lives.
WHY PATENT ARE IMPORTANT FOR DEVELOPMENT?| Understanding International Patent Classification (IPC)|World Intellectual Property Organization
-Patent protection means that the invention protected cannot be commercially made, used, distributed or sold without the consent of the patent owner or patentee
-Patents provide incentives to the individuals (Royalty)
Protection stimulates research, which results in technological development
-Patents promote innovation and dissemination of information
International Patent Classification
A61K: Preparations for Medical, Dental, or Toilet purposes
CO7G: Compounds of unknown constitution
C07K: Compounds of unknown constitution
E04G: Scaffolding; Forms; Shuttering; Building implement or other building aids
H04B: Transmission
H04L: Transmission of digital information
e.g.telegraphic communication
The IPC (International Patent Classification) is one of the most important tools available to people who want to search patent databases. It divides the world of technology up into over 70 000 categories. Whatever your technical field, you can use the IPC to zoom in to patent documents relevant to your field of work.
The IPC is a hierarchical system, with layers of increasing detail. Here is an example:
G Physics
G02 Optics
G02C Spectacles, sunglasses or goggles ...
G02C5 Construction of non-optical parts
G02C5/14 . Side members
G02C5/20 .. Adjustable, telescopic
Source: EPO
The conference will provide an interactive networking forum to both further develop and answer your queries through a vibrant exhibition room full of technology providers showcasing their technologies and other solutions, poster presentation sessions, expert led case study presentations, a high-level panel discussion, a round table discussion session, and interactive Q&A sessions from a 40-strong speaker faculty examining topics on 4 separate tracks outlined below.
Genentech, Novartis, Monsanto, THE REGENTS OF THE UNIVERSITY OF CALIFORNIA,
PIONEER HI-BRED INTERNATIONAL, INC., NOVARTIS AG, Monsanto Technology LLC,
ROCHE DIAGNOSTICS GMBH Top Patent filers & Patent recipients classified under the IPC C12.
Inventions in the field of Biochemistry & Genetic Engineering include-
Preparation of wine and other alcoholic beverages.
Preparation of Vinegar.
Apparatus for enzymology and microbiology.
Composition of microbes and enzymes.
Fermentation or enzyme-using processes to synthesise a desired chemical compound or composition or to separate optical isomers from a racemic mixture
Production of therapeutic glycoproteins -key players, innovators and industry...Dolcera Corporation
A Dolcera Report production about production of therapeutic proteins by glycosylation, major players and technological developments.
The report focuses on technology, industry and patent landscape of the concerned topic.
The Dolcera center of excellence finds about growth of a technology; competition- key players, innovators; gaps and opportunities in the technology and industry with the analyses of patents and trends as the core.
This presentation is a brief introduction to the detailed Dolcera Report on production of therapeutic proteins by glycosylation.
For more details and complete report contact info@dolcera.com
Medical Research & Analysis of Patent Activity in Medical Technology and Dental Devices: In recent times, there is a clear sign of increasing importance of filing patents to protect Research and Development activities in Medical Technology and Dental Devices. The Medical Technology domain also includes products related to diagnostic kits and monitoring devices to treat diseases. Medical technology is in fact now the largest technical field classified under International Patent Classification (IPC) A61 (MEDICAL OR VETERINARY SCIENCE; HYGIENE).
Most number of patent applications filed in A61K domain are by Nestec S.A. followed by Probi AB, Biogaia AB, N.V. Nutricia, Oncolytics Biotech Inc and Calpis co. ltd.
Sartorius is a well respected global solution provider within the biologics industry, especially for antibody and vaccine production. Our proven products and services are being diversified for upstream and downstream processing of cells and viruses for allogeneic and autologous advanced therapies.
Sartorius provides the cellular immunotherapy industry with a range of scalable single-use production technologies. Our portfolio supports viral vector transduction, cell expansion, and downstream processing steps including harvest, wash, and concentration of cells
There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Biopharmaceuticals product segments analyzed in this study comprises Monoclonal Antibodies (moAb), Erythropoietin, Biotech Vaccines, Recombinant Human (RH) Insulin, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Human Growth Hormones (HGH) and others. Therapeutic areas analyzed include Neurology, Infectious Diseases, Diabetes, Oncology, Cardiovascular and others. Biopharmaceuticals market, estimated at US$199.7 billion globally in 2013, is further projected to reach US$497.9 billion by 2020, growing at 13.5% CAGR between 2010 and 2020. Among different product segments, monoclonal antibodies (moAb) constitutes the largest product segment in the global biopharmaceuticals market accounting for an estimated share of 25.6% in 2013, equating to US$51.1 billion. In terms of therapeutic area, neurology applications is the largest market for global biopharmaceuticals with an estimated 2013 share of 28.2% valued at US$56.3 billion, and further expected reach a projected US$144.5 billion by 2020.
What are new chemical substance regulations in China? And what are toxic chemical substance regulations in China? How to compliant with these regulations? What inventories can be referred? How enterprises to determine their obligations? Answers can be found in CIRS free webinar for chemical regulations & compliance in China.
This webinar will introduce current chemical management regulations in China and how to fulfill enterprises’ obligations under these regulations. Detailed operationwill be summarized here for GHS and regulatory specialist and related stake-holders to well-understand and follow up.
Phụ lục 5. Hướng dẫn đánh giá độ ổn định vaccine dưới 1 số điều kiện nhiệt độ mở rộng được kiểm soát. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Phụ lục 4. Hướng dẫn đảm bảo chất lượng, độ an toàn, hiệu quả vaccine hạt virus tương tự papillomavirus tái tổ hợp. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Accelerate innovation and manufacturing in cell and gene therapy.pptxGenScript ProBio
The rapid expansion of the gene and cell therapy pipeline created constraints to accessing contract capacities around the globe. Innovation in gene and cell therapy expanded many drug development pipelines, and startups that are lacking internal production capacities heavily rely on contract manufacturing organizations (CDMO).
Medical Research & Analysis of Patent Activity in Medical Technology and Dental Devices: In recent times, there is a clear sign of increasing importance of filing patents to protect Research and Development activities in Medical Technology and Dental Devices. The Medical Technology domain also includes products related to diagnostic kits and monitoring devices to treat diseases. Medical technology is in fact now the largest technical field classified under International Patent Classification (IPC) A61 (MEDICAL OR VETERINARY SCIENCE; HYGIENE).
Most number of patent applications filed in A61K domain are by Nestec S.A. followed by Probi AB, Biogaia AB, N.V. Nutricia, Oncolytics Biotech Inc and Calpis co. ltd.
Sartorius is a well respected global solution provider within the biologics industry, especially for antibody and vaccine production. Our proven products and services are being diversified for upstream and downstream processing of cells and viruses for allogeneic and autologous advanced therapies.
Sartorius provides the cellular immunotherapy industry with a range of scalable single-use production technologies. Our portfolio supports viral vector transduction, cell expansion, and downstream processing steps including harvest, wash, and concentration of cells
There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Biopharmaceuticals product segments analyzed in this study comprises Monoclonal Antibodies (moAb), Erythropoietin, Biotech Vaccines, Recombinant Human (RH) Insulin, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Human Growth Hormones (HGH) and others. Therapeutic areas analyzed include Neurology, Infectious Diseases, Diabetes, Oncology, Cardiovascular and others. Biopharmaceuticals market, estimated at US$199.7 billion globally in 2013, is further projected to reach US$497.9 billion by 2020, growing at 13.5% CAGR between 2010 and 2020. Among different product segments, monoclonal antibodies (moAb) constitutes the largest product segment in the global biopharmaceuticals market accounting for an estimated share of 25.6% in 2013, equating to US$51.1 billion. In terms of therapeutic area, neurology applications is the largest market for global biopharmaceuticals with an estimated 2013 share of 28.2% valued at US$56.3 billion, and further expected reach a projected US$144.5 billion by 2020.
What are new chemical substance regulations in China? And what are toxic chemical substance regulations in China? How to compliant with these regulations? What inventories can be referred? How enterprises to determine their obligations? Answers can be found in CIRS free webinar for chemical regulations & compliance in China.
This webinar will introduce current chemical management regulations in China and how to fulfill enterprises’ obligations under these regulations. Detailed operationwill be summarized here for GHS and regulatory specialist and related stake-holders to well-understand and follow up.
Phụ lục 5. Hướng dẫn đánh giá độ ổn định vaccine dưới 1 số điều kiện nhiệt độ mở rộng được kiểm soát. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Phụ lục 4. Hướng dẫn đảm bảo chất lượng, độ an toàn, hiệu quả vaccine hạt virus tương tự papillomavirus tái tổ hợp. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Accelerate innovation and manufacturing in cell and gene therapy.pptxGenScript ProBio
The rapid expansion of the gene and cell therapy pipeline created constraints to accessing contract capacities around the globe. Innovation in gene and cell therapy expanded many drug development pipelines, and startups that are lacking internal production capacities heavily rely on contract manufacturing organizations (CDMO).
Yaohai Bio-Pharma is the first and the largest biologics CRTDMO (Contract Research, Testing, Development and Manufacturing Organization) focusing on microbial expression system in China, which was established in China Medical City, Taizhou with a 20, 000 square meters plant.
As a one-stop biologics CRTDMO, Yaohai provide customized end-to-end solutions from DNA to drug substance manufacturing and product fill & finish across diversified modalities, such as recombinant proteins, peptides and polypeptides, enzymes, antibody fragments and nano-antibodies, plasmid DNA and mRNA, Glyco-polymers, virus-like particle (VLP), to meet global customers’ clinical and commercial needs in biological drugs, biosimilars, vaccines and diagnostics for human and veterinary use.
https://www.yaohai-bio.com.cn/downloadfile
OneMedForum New York 2010 - Company Presentation. Access Pharmaceuticals, Inc., a emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing those products through clinical development.
Targovax Next generation immune activators for solid tumorsRoarFredriksen1
Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors. Targovax’s focus is to activate the patient’s immune system to fight cancer, and to bring benefit to cancer patients with few available treatment alternatives. Targovax is developing its product candidates in different cancer indications, including melanoma, mesothelioma, and multiple myeloma, and has demonstrated a favorable safety and tolerability profile.
Targovax’s lead clinical candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system against the tumor. Following very encouraging clinical data in several indications, both as monotherapy and in combinations, ONCOS-102 is progressing into a randomized phase 2 trial in melanoma patients resistant to PD-1 checkpoint inhibitor treatment.
Building on successful clinical studies which have provided deep mechanistic insights into the tumor biology and the human immune systems, Targovax is researching circular RNA (circRNA) as novel cancer medicines. In addition, Targovax has a KRAS immunotherapy program, with lead cancer vaccine candidate, TG01, expected to enter the clinic in an enhanced format in the second half of 2022. Together this provides Targovax with a rich pipeline of innovative future immunotherapy product candidates to follow ONCOS-102.
Endotoxin Control and Clearance in BiomanufacturingMilliporeSigma
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Richard's aventures in two entangled wonderlandsRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
What is greenhouse gasses and how many gasses are there to affect the Earth.moosaasad1975
What are greenhouse gasses how they affect the earth and its environment what is the future of the environment and earth how the weather and the climate effects.
The ability to recreate computational results with minimal effort and actionable metrics provides a solid foundation for scientific research and software development. When people can replicate an analysis at the touch of a button using open-source software, open data, and methods to assess and compare proposals, it significantly eases verification of results, engagement with a diverse range of contributors, and progress. However, we have yet to fully achieve this; there are still many sociotechnical frictions.
Inspired by David Donoho's vision, this talk aims to revisit the three crucial pillars of frictionless reproducibility (data sharing, code sharing, and competitive challenges) with the perspective of deep software variability.
Our observation is that multiple layers — hardware, operating systems, third-party libraries, software versions, input data, compile-time options, and parameters — are subject to variability that exacerbates frictions but is also essential for achieving robust, generalizable results and fostering innovation. I will first review the literature, providing evidence of how the complex variability interactions across these layers affect qualitative and quantitative software properties, thereby complicating the reproduction and replication of scientific studies in various fields.
I will then present some software engineering and AI techniques that can support the strategic exploration of variability spaces. These include the use of abstractions and models (e.g., feature models), sampling strategies (e.g., uniform, random), cost-effective measurements (e.g., incremental build of software configurations), and dimensionality reduction methods (e.g., transfer learning, feature selection, software debloating).
I will finally argue that deep variability is both the problem and solution of frictionless reproducibility, calling the software science community to develop new methods and tools to manage variability and foster reproducibility in software systems.
Exposé invité Journées Nationales du GDR GPL 2024
Salas, V. (2024) "John of St. Thomas (Poinsot) on the Science of Sacred Theol...Studia Poinsotiana
I Introduction
II Subalternation and Theology
III Theology and Dogmatic Declarations
IV The Mixed Principles of Theology
V Virtual Revelation: The Unity of Theology
VI Theology as a Natural Science
VII Theology’s Certitude
VIII Conclusion
Notes
Bibliography
All the contents are fully attributable to the author, Doctor Victor Salas. Should you wish to get this text republished, get in touch with the author or the editorial committee of the Studia Poinsotiana. Insofar as possible, we will be happy to broker your contact.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
Toxic effects of heavy metals : Lead and Arsenicsanjana502982
Heavy metals are naturally occuring metallic chemical elements that have relatively high density, and are toxic at even low concentrations. All toxic metals are termed as heavy metals irrespective of their atomic mass and density, eg. arsenic, lead, mercury, cadmium, thallium, chromium, etc.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Nutraceutical market, scope and growth: Herbal drug technology
Dyadic technology oct 2018
1. Dyadic – C1 Technology
October, 2018
Reinventing biological
vaccine and drug
development &
production
2. DYADIC INFORMATION 2
Safe Harbor Regarding Forward-Looking Statements
Certain statements contained in this presentation are forward-looking statements within the meaning of the
federal securities laws. These forward-looking statements involve risks, uncertainties and other factors that
could cause Dyadic’s actual results, performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by such forward-looking statements. Any
forward-looking statements speak only as of the date of this presentation and, except as required by law,
Dyadic expressly disclaims any intent or obligation to update or revise any forward-looking statements to
reflect actual results, any changes in expectations or any change in events. Factors that could cause results to
differ materially are discussed in Dyadic’s publicly available filings, including information set forth under the
caption “Risk Factors” in our December 31, 2017 Annual Report filed with OTC Markets on March 27, 2018
and our March 31, 2018 Quarterly Report filed with the OTC Markets on May 10, 2018. New risks and
uncertainties arise from time to time, and it is impossible for us to predict these events or how they may
affect us.
4. DYADIC INFORMATION 4
Commercial Success in Industrial Biotech > $110 Million
Hyper productive C1 gene expression platform developed
Enzyme expression levels achieved >100 g/l with ~80% purity
Approved as safe (GRAS) by FDA for food and feed applications
C1 enzymes produced in up to 500,000 liter scale tanks
Industrial Enzymes sold to customers in 35 countries
C1 Related License Deals, Milestones & Equity in excess of $35 million
Dyadic sold its Industrial Technology business
to DuPont’s Industrial Biosciences business (“DuPont”) for
$75 million in cash
12/31/2015
5. DYADIC INFORMATION 5
Dyadic Board – Decades of Big Pharma Experience
Arindam Bose
Dr. Bose worked at Pfizer for 34 years
and held leadership roles within
bioprocess development and clinical
manufacturing and is widely
recognized as a Key Thought Leader
in the biopharmaceutical industry.
Barry Buckland
Dr. Buckland worked at Merck for 29 years
where he served in a number of senior R&D
leadership roles focusing on fermentation and
bioprocess development and the commercial
manufacturing of biologics and is widely
recognized as a Key Thought Leader in the
biopharmaceutical industry. Currently, Dr.
Buckland is the Executive Director, NIIMBL
(National Institute for Innovation in
Manufacturing Biopharmaceuticals) A public-
private consortium dedicated to advancing
biopharmaceutical manufacturing innovation.
Michael P. Tarnok
Mr. Tarnok (Dyadic chairman) spent
the majority of his career at Pfizer and
is a seasoned finance and operational
executive with extensive experience in
the pharmaceutical industry. Currently
also serves on the Board of the Global
Health Council, and Ionetix, Inc. Prior
Board service includes Keryx
Biopharmaceuticals, Inc., where he also
served as Chairman of the Board.
Vice President, Biotherapeutics
Pharmaceutical Sciences, External
Affairs and Biosimilar Strategy
Vice President, Bioprocess
R&D, Merck Research
Laboratories
Senior Vice President in
Pfizer’s US Pharmaceutical
Division
EXPERIENCELASTPOSITION
6. DYADIC INFORMATION 6
Dyadic Overview
HQ: Jupiter, FL
BD&L: London
R&D Management: Budapest
R&D: Valladolid
R&D: Helsinki
1979 FOUNDED
20+ YEARS EXPERIENCE IN
PHARMA / FUNGAL GENE
EXPRESSION PLATFORMS
7. DYADIC INFORMATION 7
On-going Research Programs and Collaborations
Mitsubishi Tanabe
Pharma
To help Mitsubishi Tanabe
overcome specific gene
expression challenges of two
important therapeutic
compounds using C1
technology.
Israel Institute for Biological
Research (IIBR)
To further advance C1 for the
development and manufacture of
recombinant vaccines and
neutralizing agents comprising
targeted antigens and
monoclonal antibodies to combat
emerging disease and threats.
Other funded proof of concept
research collaborations
To explore the potential of C1
technology to produce active
moiety.
To test the feasibility of C1
technology to produce seven
different molecular biology
enzymes for pharmaceutical use.
Sanofi-Aventis
Fully funded collaboration with
Sanofi-Aventis to explore the
potential of C1 to produce
multiple classes of biologic
vaccines & drugs
8. DYADIC INFORMATION 8
How Dyadic Leverages C1 Advantages for Biologics
Efficient vast
screening system
for drug discovery
Growing on 24 or 96 MTP
Fast development
timeline for
Biologics
Simple
fermentation
process in
stainless steal
bioreactors
Success in Single
use reactors
Low cost of USP
& DSP
- High productivity -
- Advanced genetic tools (Efficient transformation) -
- Efficient secretory system -
- Low viscosity -
- Wide range of fermentation conditions -
- Fast growing -
- Grow on simple defined media -
- Can tolerant high glucose concentration –
- Easy scaling up (was scaled up to 100m3)-
9. 9
C1 Strain Development for Therapeutic Protein Production
LC strain
Low background
High proteolytic
HC strain
High Background
High proteolytic
0.1 g/L
1.0 g/L
2.0 g/L
10 g/L
15 g/L
? g/L
DNL103 - DNL115
Lower proteolytic
background
DNL120 -
Lower proteolytic
background
2016 2017 2018 2019 2020
DNL ?
Very Low proteolytic
background
(80 g/l enzyme for Bioindustrials application)
(120 g/l cellulosic enzyme for Biofuel)
New C1 strains
for biologics
Glycoengineering
DYADIC INFORMATION
10. DYADIC INFORMATION 10
Production of Stable Proteins
The viability of the protease
deletion strains was not
negatively affected
Growth rate of protease deletion
strains increased at one of the
steps – 2.0h generation time
Under construction
C1 Lineage of
Proteases
Deletion Strains
11. 11
The Protease Expression Library
C1 proteases were identified and expressed individually in P. pastoris as secreted proteins
The proteases were identified by RNASeq, Zymogram and genome analysis.
Example: identification of proteases that affecting the stability of a specific protein: (e.g., an Antigen)
• Purified Antigen (produced in C1) was spiked into culture supernatants of the protease library and
degradation was analyzed after 3h incubation (only half of the selected proteases are presented)
• The proteases that were found to be involved in Antigen degradation were subjected to the
protease deletion strain process.
Conrol
Standard
384
393
390
393
401
410
413
416
417
426
430
436
388
398
381
N
start
Prot.A
Prot.B
100
75
50
37
25
20
100
75
50
37
25
20
Prot.C
Prot.D
Prot.G
Prot.E
Prot.F
Prot.H
Example of the identification of several
active proteases by the C1 expression library
DYADIC INFORMATION
12. DYADIC INFORMATION 12
Reducing the Proteolytic Activity
1) Protease deletion strains 2) Wide range of Temperature 3) Wide range of pHs
The 10-12 X protease deletion strains, under
production at optimized temp. and pH will
be used to produce stable Biologics
13. DYADIC INFORMATION 13
Glycoengineering in C1
The goals for C1 glycoengineering
1. High levels of G0 glycans
2. Adding fucosylation: high FG0
3. Adding galactosylation: high G2 and FG2
4. Good N-glycosylation site occupancy on therapeutic proteins (Mabs)
C1 typical Glycan structure
Unlike most fungi and yeasts, C1 does not have ‘high’ mannose (branched 30-
50 mannose species), but rather has ‘oligo’ mannose and hybrid-type
structure.
The native C1 glycan pattern is relatively complex with high mannose type
(Man3-Man9) and hybrid type (Man3HexNac-Man8HexNac) glycan forms
So far, O-glycosylation was not identified in therapeutic proteins
expressed in C1 but minor level is still possible
C1 future Glycostructures
Glycoengineering work is being applied to C1 strain to create a
strain that produces proteins with defined human glycoforms
2 approaches are being applied: i) ’Classical’ mammalian
pathway, ii) Alg3 pathway.
About 13 steps will be applied for 1.5 – 2 years work
The first steps of Glycoengineering C1 cells have been done
successfully.
G0 G0F G2 G2F
14. 14
Applying alg3 deletion pathway
We have deleted the C1 Δalg3 gene and over-expressed a native or a
heterologous Mannosidase I from alg3 locus
With Δalg3 deletion only the Man3 level is about 50%
With both modifications Man3 level rises up to 80%
All fungal type high mannose and hybrid glycans are omitted
Proteodynamics (France) analyzed glycans from
native protein samples of glycoengineered C1 strains
(indicated) by permethylation + MALDI-TOF analysis
• No fungal high mannose structures present
• Up to 80% of Man3 structure, the important
precursor for human glycoforms
No negative effects on cell viability have been
observed with any of the modifications done
DYADIC INFORMATION
15. 15
Near future goals in glycoengineering
50% G0 levels by the end of 2018
80% G0 levels by end of Q2 2019
80% FG0 levels by September 2019
G0 G0FM3
DYADIC INFORMATION
16. DYADIC INFORMATION 16
C1 Fermentation Technology
Fed-batch
Process
From MTP to Large scale
mAbs productivity
24 wells MTP – 1mg/4ml
1L fermentor – 1.7/g/l/d
30L fermentor – 2.4 g/l/d
Easily available defined media components – glucose, salts, micro and macro elements, AA, vitamins.
Fed-batch technology with glucose feeding
Low viscosity culture due to morphology changes (propagule)
No need for induction
Protein is secreted to the media
30-40% biomass
pH: 5-8, Temp: 25 - 42°C.
1L to 500,000L fermentation scale
17. DYADIC INFORMATION 17
MAbY Expressions by C1
Fermentations carried out for mAbY
production with vessel volumes, culture
volumes, and antibody titres.
SDS gel analysis of the mAbY antibody purified from
the fermentations by protein A affinity
chromatography:
A. Fermentation MT15 in a 10 litre vessel,
B. Fermentations MT16-18 in a 1 litre vessel.
Input depicts the sample loaded to the protein A
column, fr4-fr6 are the elution fractions obtained from
the chromatography.
Samples of CHO-produced mAbY are shown as
controls.
Ferm entation
#
Vessel volume
(1)
Initial (final)
culture volume (1)
Antibody
titre (g/l)
15 10 8 (10.5) 8.0
16 1 0.8 (1.1) 6.3
17 1 0.8 (1.1) 6.5
18 1 0.8 (1.1) 7.9
18. DYADIC INFORMATION 18
MAbY Binding Assay by Biacore T200
Studying the interaction of mAbs in real time
MAbY for which the ligand was commercially
available was produced in CHO (control Mab) and
C1 (C1-produed mAb)
The binding properties of a pharma’s mAbs to the
ligand were compared in a Biacore T200 assay
The control mAbY and C1-produced MAbY
showed virtually indistinguishable binding
kinetics.
Similar results were obtained with other mAb
mAbY
Ligand
19. DYADIC INFORMATION 19
Media and process Development
Medium plus feeding
improvement lead to a mAbY
titer of 9 g/L at 90 h, and increase
in specific productivity
+ 50%
mAbY production titer (g/L)
X 2.3
Specific mAbY production (g/g total protein)
€/g
20. DYADIC INFORMATION 20
Success in Expressing Certolizumab (Fab) by C1
Successful expression of Certolizumab
ELISA kit was used to measure and conform Certolizumab expression level (triplicates of samples were
quantified)
The calculated expression level was 12.0 g/l, corresponding to 2.6 g/l/day production rate.
By further optimization of the fermentation process up to 7 days we would expect to see even higher
expression levels.
7 days = 18 g/L
2 X 7 days = 36 g/L
Certolizumab production (g/L)
21. DYADIC INFORMATION 21
Success In Fc-Fusion Expressions by C1
Successful expression of Fc-Fusion protein
C1 expressing Fc-Fusion was cultivated in 1 litre fermentors at 38oC and the product was analysed by Western
Blotting
The protein A purification yield from day 6 was 8.1 g/l, corresponding to 1.35 g/l/day production rate.
The fermentation was not fully optimized
22. 22
Protease deficient strains 9Δ-10Δ: - spiking with Fc-Fusion (*)
24-well cultivation of protease deficient strains in standard production medium at 35°C, day 4 supernatants
Fc-Fusion reference, ProA purified, 25ng/µl in spiking reactions at 35°C
Time points 0h, 1h, 3h, o/n and o/2n
Detection with Fc-antibody (red) and Fused protein antibody (green) -> combined signal is yellow
Fc-Fusion stays intact in all supernatants, especially in the one from 10Δ Prot. D strain
Different FC-Fusion molecule than in slide 28
DYADIC CONFIDENTIAL INFORMATION
23. DYADIC INFORMATION 23
Success In Bispecific Expression
In a few months work we have been able to express a bispecific
antibody using C1 and provide sufficient quantities of this antibody to
our collaborator which they were not able to do previously using other
expression systems after two years of work.
Purified samples of bispecific protein
24. 24
Blue – C1-produced bispecific
Red – CHO-produced bispecific
Bispecific produced in C1 and CHO have identical/similar activity
• C1- and CHO-produced bispecifics were assayed in an in vitro cellular activity assay
• The dose response curves are very similar
• No negative effects of the C1-derived potential impurities in cellular assays
DYADIC CONFIDENTIAL INFORMATION
25. 25
Success in Expressing High Level of ZAPI Antigen
The New strain using SES promoter system significantly increased the production and stability of
the target antigen when 723 mg/L was reached in 94 hrs.
SES construct was transformed in two 8x protease deletion strains transformants were cultivated in 24-well
MTP with the addition of protease inhibitors.
SES clones with several fold increase in production (compared to bgl) were identified
DYADIC INFORMATION
26. DYADIC INFORMATION 26
Ch-VLP Platform Technology Basis
VP2 protein is a structural protein of the Infectious Bursitis virus (IBDV;
Gumboro) what naturally auto assemble forming Virus Like Particles
Translation
Assembling
process
x60
VLPs
VP2
protein
VP2
gene
(+34) 983 54 85 63
info@bdibiotech.com
C/ Louis Proust, 13
47151 Boecillo (Valladolid) - Spain
27. DYADIC INFORMATION 27
Success in expressing secreted VLP by C1
VLP is expressed into DNL121 under bgl promoter.
Productivity reaches 300mg/L
Intracellular remains around 70mg/L
Extracelular-VLP
Intracelular-VLP
28. DYADIC INFORMATION 28
Visualization of VLPs Produced by C1
Intracellular and extracellular fractions of SP-VLP have been visualized by
Transmission Electronic Microscopy (TEM)
Extracellular VLPs produced by C1 are
perfectly conformed. The structure is
homogeneous in size and aspect.
The production level of the extracellular VLP
produced by C1 was 300 mg/L.
The production level of the intracellular
remained VLP produced by C1 was 70 mg/L
In comparison, extracellular fraction couldn’t
be produced by S. cerevisiae.
Intracellular VLP produced by S. cerevisiae
reached a level of 70 mg/L
VLP produced by C1 Control
Extracellular
fraction
Intracellular
fraction
S. cerevisiae
300mg/L (112,5H) 70mg/L (112,5H) 70mg/L
29. DYADIC INFORMATION 29
The Expression of Recombinant HAs by C1
Expression and performance of 5 different HA’s
Influenza strain Expression Functional HA
New Caledonia, A (H1N1) Yes Yes
Texas, A (H1N1) Yes Yes
Puerto Rico A (H1N1) Yes Yes
California, A (H1N1) Yes Yes
Florida B Yes Yes
Agglutination test• Expressed as a membrane-bound trimer
• Titers variable
30. DYADIC INFORMATION 30
Immunogenicity Study of HA/NC Produced by C1
HA/New Caledonia
The full length recombinant HA
produced in C1 did not induce any
negative clinical signs in mice.
• No weight loss.
• No negative clinical signs during
the experiment (visual
observations taken each day).
The full length of HA/New
Caledonia produced in C1
showed excellent immunogenic
properties in mice better than
the control of HA/New
Caledonia produced by
Baculovirus.
C1 can potentially produce levels of 1 g/L of
HAs and other antigens in 5 days fermentation
therefore:
• In seasonal Influenza Vaccine—total doses
distributed = 146M/year
• Each 0.5 mL dose is formulated to contain: 15
µg of HA for each strain.
• Thus, 3 X 1000L scale fermentation runs will be
able to supply the annual global HA/strain
needs against Influenza of 2,175 g.
31. DYADIC INFORMATION 31
Metabolic modeling and Proteomic Analysis for Next
Stage of Strain Engineering
Based on C1 genomic sequence, CoReCo platform for metabolic model reconstruction was
used to build a genome-scale metabolic model of C1 for further strain development work
CoReCo:
Esa Pitkänen et al. 2014 Plos Comput Biol.
Sandra Castillo et al. 2016 Biotechnol Biofuels.
32. DYADIC INFORMATION 32
Summary
Shorter development &
production cycles
Higher protein yields
Lower CapEx/OpEx
Higher purity & greater
protein recovered
Low Cost Media / No
Viral Inactivation
No negative clinical
signs in mice studies
R&D
Collaborations
Licensing
Arrangements
Other Commercial
Opportunities
Dyadic is looking for partners in the biopharmaceutical space to
exploit the potential of C1. Contact mjones@dyadic.com