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
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).
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.
This document summarizes DEMO Pharmaceutical's investments in biotechnology, including the development and production of monoclonal antibodies. It discusses:
- DEMO's plans to build a new state-of-the-art facility for monoclonal antibody development and production, including a bioacademy, with an investment of 100 million euros over 10 years.
- The manufacturing process for monoclonal antibodies, from cell line development through fill and finish.
- Quality control testing to ensure safety, identity, purity and potency of biologic drugs.
- Biosimilar development which progresses through comparative in vitro and clinical studies to demonstrate similarity to a reference product.
- The impact of DEMO's investments, which will create jobs,
Kemwell biologics presentation bp April 2018MithaliRosario
Founded in 1980, Kemwell provides customized process/product development and manufacturing to biopharmaceutical organizations worldwide. Our facilities are located in Bangalore, India and were built with technical guidance from Boehringer Ingelheim, providing customers with state-of-the-art technology along with the benefit of cost-effective manufacturing.
The 15,000 sq. m. facility consist of a cGMP drug substance manufacturing facility with 2x2000L bioreactors and a sterile fill and finish facility for cGMP drug product manufacturing with a floor for process development laboratories to support production of protein therapeutics from mammalian-cell culture or microbial fermentation.
For over 30 years, Kemwell supported pharmaceutical companies with their development and manufacturing needs. We developed and manufactured drugs for some of the world’s top pharmaceutical companies including Bayer, GlaxoSmithKline, Merck KGaA, Novartis and Pfizer. In 2017, Kemwell sold its pharmaceutical business to Recipharm AB but continues to leverage its 30-year experience to provide biotech customers with cost-effective solutions.
Dyadic has developed a proprietary fungal gene expression platform called C1 that can speed up development and lower production costs of biologics compared to traditional systems. The C1 technology uses a filamentous fungus strain that is able to express complex proteins through fermentation. Dyadic has generated clinical and commercial grade proteins using C1 and is seeking partnerships with biopharmaceutical companies to further develop C1 for vaccine and drug production.
This investor presentation provides an overview of Viropro, Inc., a contract development and manufacturing organization for biotech drugs. It discusses the growing market opportunity in outsourcing biopharmaceutical R&D and manufacturing services. Viropro plans to build a global network through acquisitions like Alpha Biologics, which owns an FDA-compliant biomanufacturing facility in Malaysia. This "string of pearls" model across Asia and Europe is aimed to provide world-class development and manufacturing services to biotech companies in a cost-effective manner. The presentation makes the case that an investment of $40 million in Viropro over two funding rounds could yield a return of 10x and 46% IRR through an
This document discusses Targovax's strategy for outsourcing clinical manufacturing and quality control activities. As a virtual biotech company, Targovax outsources all development, manufacturing, and testing of its three investigational medicinal products - a peptide vaccine (TG), recombinant GM-CSF, and an oncolytic virus (ONCOS-102). The document describes Targovax's current contract manufacturing organizations for clinical supply and its plans to select new partners to support late-stage clinical trials and commercialization. A multi-stage selection process is outlined involving screening of potential partners, requests for proposals, audits, and selection of organizations meeting Targovax's regulatory and capacity requirements.
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).
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.
This document summarizes DEMO Pharmaceutical's investments in biotechnology, including the development and production of monoclonal antibodies. It discusses:
- DEMO's plans to build a new state-of-the-art facility for monoclonal antibody development and production, including a bioacademy, with an investment of 100 million euros over 10 years.
- The manufacturing process for monoclonal antibodies, from cell line development through fill and finish.
- Quality control testing to ensure safety, identity, purity and potency of biologic drugs.
- Biosimilar development which progresses through comparative in vitro and clinical studies to demonstrate similarity to a reference product.
- The impact of DEMO's investments, which will create jobs,
Kemwell biologics presentation bp April 2018MithaliRosario
Founded in 1980, Kemwell provides customized process/product development and manufacturing to biopharmaceutical organizations worldwide. Our facilities are located in Bangalore, India and were built with technical guidance from Boehringer Ingelheim, providing customers with state-of-the-art technology along with the benefit of cost-effective manufacturing.
The 15,000 sq. m. facility consist of a cGMP drug substance manufacturing facility with 2x2000L bioreactors and a sterile fill and finish facility for cGMP drug product manufacturing with a floor for process development laboratories to support production of protein therapeutics from mammalian-cell culture or microbial fermentation.
For over 30 years, Kemwell supported pharmaceutical companies with their development and manufacturing needs. We developed and manufactured drugs for some of the world’s top pharmaceutical companies including Bayer, GlaxoSmithKline, Merck KGaA, Novartis and Pfizer. In 2017, Kemwell sold its pharmaceutical business to Recipharm AB but continues to leverage its 30-year experience to provide biotech customers with cost-effective solutions.
Dyadic has developed a proprietary fungal gene expression platform called C1 that can speed up development and lower production costs of biologics compared to traditional systems. The C1 technology uses a filamentous fungus strain that is able to express complex proteins through fermentation. Dyadic has generated clinical and commercial grade proteins using C1 and is seeking partnerships with biopharmaceutical companies to further develop C1 for vaccine and drug production.
This investor presentation provides an overview of Viropro, Inc., a contract development and manufacturing organization for biotech drugs. It discusses the growing market opportunity in outsourcing biopharmaceutical R&D and manufacturing services. Viropro plans to build a global network through acquisitions like Alpha Biologics, which owns an FDA-compliant biomanufacturing facility in Malaysia. This "string of pearls" model across Asia and Europe is aimed to provide world-class development and manufacturing services to biotech companies in a cost-effective manner. The presentation makes the case that an investment of $40 million in Viropro over two funding rounds could yield a return of 10x and 46% IRR through an
This document discusses Targovax's strategy for outsourcing clinical manufacturing and quality control activities. As a virtual biotech company, Targovax outsources all development, manufacturing, and testing of its three investigational medicinal products - a peptide vaccine (TG), recombinant GM-CSF, and an oncolytic virus (ONCOS-102). The document describes Targovax's current contract manufacturing organizations for clinical supply and its plans to select new partners to support late-stage clinical trials and commercialization. A multi-stage selection process is outlined involving screening of potential partners, requests for proposals, audits, and selection of organizations meeting Targovax's regulatory and capacity requirements.
This document discusses Targovax's strategy for outsourcing clinical manufacturing and quality control activities. As a virtual biotech company, Targovax outsources all development, manufacturing, and testing of its three investigational medicinal products - a peptide vaccine (TG), recombinant GM-CSF, and an oncolytic virus (ONCOS-102). The document describes Targovax's current contract manufacturing organizations for clinical supply and its plans to select new partners to support late-stage clinical trials and commercialization. It provides an overview of Targovax's multi-stage process for evaluating and selecting these strategic contract development and manufacturing partners.
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.
Parveen Bhatarah has over 15 years of experience in pharmaceutical management, API development, drug substance manufacturing, technology transfer, and formulation development. They have successfully developed, scaled up, and manufactured a wide range of drug substances and formulations, and have transferred technologies for commercial manufacturing. Parveen also has experience evaluating and qualifying CMOs, building industry partnerships, and presenting scientific findings to regulatory agencies.
The biopharmaceutical industry needs high-performance processing through the establishment of next-generation solutions to improve efficiency and effectiveness. The shift in the industry toward efficient monoclonal antibody (mAb) processing has necessitated the development of novel approaches.
In this webinar, you will learn:
• What benefits upstream process intensification brings to the manufactures addition to higher productivity
• Several scenarios with process modeling data to quantify financial benefits and value
• Perfused seed train process development data taken with our new Cellicon™ Solution and Cellvento® 4CHO-X expansion medium
Upstream process intensification can bring significant benefits to manufacturers in terms of smaller facilities, manufacturing flexibility, and reduction in footprint, with achieving significantly higher productivity. Several scenarios for Mab production become apparent with the implementation of perfusion-based operations, especially for the seed train. We will identify these scenarios with process modeling data to quantify their financial benefits and value. In addition, we will share perfused seed train process development data resulting from the use of our new Cellicon™ Solution and Cellvento® 4CHO-X expansion medium.
This document discusses using a high seed fed-batch (HSFB) process compared to a standard fed-batch process for monoclonal antibody production. It presents results from experiments conducted using 3L bioreactors. The HSFB process uses an inoculation density of 5x106 cells/mL compared to 0.5x106 cells/mL for the standard process. The HSFB process achieved a titer increase within the variability range and reached that titer 3 days earlier than the standard process. Other metrics like viable cell density, viability, specific productivity, and metabolite levels were also compared between the two processes. The results suggest the HSFB process can accelerate production timelines while maintaining comparable product quality.
This document describes Bram-Cor's turnkey pharmaceutical projects. Bram-Cor specializes in designing, engineering, constructing, and validating complete new pharmaceutical facilities. Their services include procuring licenses and know-how transfers, conceptual and detailed engineering, validation planning, equipment installation and testing, training, and regulatory support. They have capabilities across many drug product types including intravenous solutions, dialysis products, blood bags, plasma fractionation, biotechnology, and multipurpose facilities. Bram-Cor aims to provide clients with reliable technologies and ensure their projects meet all applicable regulatory and quality requirements.
Boccard is a global turnkey constructor with over 3000 employees across 18 countries. They have over 100 years of experience in designing, building, and maintaining process facilities for industries like pharmaceutical, food, beverage, and more. Boccard offers full lifecycle services from engineering and fabrication to automation, validation, and long-term maintenance. They have significant experience and references in pharmaceutical and biotech industries for projects like vaccine production, enzyme manufacturing, chromatography systems, and complete turnkey biotech facilities.
This document summarizes PCT's vision and history as a leader in cell therapy manufacturing. PCT aims to make transformative cell-based therapies accessible to all through providing high-quality and scalable manufacturing services. Over 30 years, PCT has gained unprecedented expertise manufacturing over 20 cell therapy products and treating over 6,000 patients. PCT partners with companies from start-ups to large pharmaceutical companies, and aims to guide clients through the entire development and manufacturing process.
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...Merck Life Sciences
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Adherent Lentivirus Suspension Production & Manufacturing.pptxGenScript ProBio
GenScript ProBio is the world's leading biotech company founded in 2002 in New Jersey USA. We at GenScript ProBio provide various solutions based on gene synthesis technology including lentivirus manufacturing, CAR-T IND filing, plasmid manufacturing & production, and many more.
High Quality Integrated Drug R&D Servicesmedicilonz
End-to-end services and solutions covering the entire spectrum of preclinical biopharmaceutical R&D. Supporting everything from target discovery, candidate development, preclinical screening and drug safety evaluation through IND submission. https://www.medicilon.com/about-medicilon/
Bacthera Company Presentation October 2020Felix Faupel
Bacthera is a leading CDMO in live biotherapeutic products (LBPs) with 3 manufacturing sites and expertise in microbiology, processes, and innovation. They provide end-to-end development and manufacturing services from pre-clinical through commercialization. Bacthera was established in 2014 through a collaboration between Chr. Hansen and Lonza combining their complementary LBP expertise.
- Biologics manufacturing is growing rapidly due to increased biologics sales and pipeline products. Biologics are projected to exceed $390 billion by 2020 and nearly reach parity with small molecules.
- Many CMOs are expanding biologics manufacturing capacity through new facilities and production trains featuring single-use technologies and larger bioreactors up to 2000L. Locations include the US, Europe, and Asia.
- Emerging biologics modalities like cell and gene therapies are driving additional manufacturing capacity investments in viral vector production and cell therapy services.
Covering a Spectrum of New Product Development Technologies - From Cells to C...KBI Biopharma
KBI Biopharma provides analytical services, process development, and manufacturing for biologics from early discovery through commercialization. It has locations in Durham, Boulder, RTP, and The Woodlands focused on mammalian and microbial development as well as cell therapy. KBI leverages platform approaches for monoclonal antibodies, bispecific antibodies, fusion proteins, and emerging modalities. It has also partnered with Selexis to utilize their cell lines for development programs and has integrated Selexis cell lines into its platforms to rapidly develop cell lines from DNA to drug substance within 9 months.
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
Therapure Biopharma operates a large cGMP compliant manufacturing facility and can assist with scaling drug production processes up to clinical or commercial levels. They maintain various cleanroom environments and utilities for protein and antibody manufacturing. During scale up, Therapure works closely with clients to refine processes, standard operating procedures, and batch records. They have experience utilizing different sources of API and offer services for upstream, midstream, and downstream protein production including cell culture, purification, filling, and analytical testing.
Dyadic International is developing its C1 gene expression platform to more accessibly and affordably produce biologic vaccines and drugs. C1 uses a proprietary fungal system that offers higher productivity, lower costs, and a faster development timeline compared to the commonly used CHO system. Dyadic has collaborative research programs underway with companies like Sanofi and Mitsubishi Tanabe Pharma to evaluate C1 for producing various biologics. The company aims to license its C1 technology to partners in order to disrupt biomanufacturing and address the growing demand for more affordable biologic treatments.
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.
This document provides an overview of market research services from BioInformatics LLC for companies developing new life science products. It discusses the importance of conducting market research during new product development. Key stages in the product development process include generating ideas, assessing feasibility, development, and product launch. Market research methods that can be used during each stage are described, including focus groups, surveys, and conjoint analysis. Cost-effective options like virtual focus groups and RateMyProduct are also presented for companies with limited budgets.
This document discusses Targovax's strategy for outsourcing clinical manufacturing and quality control activities. As a virtual biotech company, Targovax outsources all development, manufacturing, and testing of its three investigational medicinal products - a peptide vaccine (TG), recombinant GM-CSF, and an oncolytic virus (ONCOS-102). The document describes Targovax's current contract manufacturing organizations for clinical supply and its plans to select new partners to support late-stage clinical trials and commercialization. It provides an overview of Targovax's multi-stage process for evaluating and selecting these strategic contract development and manufacturing partners.
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.
Parveen Bhatarah has over 15 years of experience in pharmaceutical management, API development, drug substance manufacturing, technology transfer, and formulation development. They have successfully developed, scaled up, and manufactured a wide range of drug substances and formulations, and have transferred technologies for commercial manufacturing. Parveen also has experience evaluating and qualifying CMOs, building industry partnerships, and presenting scientific findings to regulatory agencies.
The biopharmaceutical industry needs high-performance processing through the establishment of next-generation solutions to improve efficiency and effectiveness. The shift in the industry toward efficient monoclonal antibody (mAb) processing has necessitated the development of novel approaches.
In this webinar, you will learn:
• What benefits upstream process intensification brings to the manufactures addition to higher productivity
• Several scenarios with process modeling data to quantify financial benefits and value
• Perfused seed train process development data taken with our new Cellicon™ Solution and Cellvento® 4CHO-X expansion medium
Upstream process intensification can bring significant benefits to manufacturers in terms of smaller facilities, manufacturing flexibility, and reduction in footprint, with achieving significantly higher productivity. Several scenarios for Mab production become apparent with the implementation of perfusion-based operations, especially for the seed train. We will identify these scenarios with process modeling data to quantify their financial benefits and value. In addition, we will share perfused seed train process development data resulting from the use of our new Cellicon™ Solution and Cellvento® 4CHO-X expansion medium.
This document discusses using a high seed fed-batch (HSFB) process compared to a standard fed-batch process for monoclonal antibody production. It presents results from experiments conducted using 3L bioreactors. The HSFB process uses an inoculation density of 5x106 cells/mL compared to 0.5x106 cells/mL for the standard process. The HSFB process achieved a titer increase within the variability range and reached that titer 3 days earlier than the standard process. Other metrics like viable cell density, viability, specific productivity, and metabolite levels were also compared between the two processes. The results suggest the HSFB process can accelerate production timelines while maintaining comparable product quality.
This document describes Bram-Cor's turnkey pharmaceutical projects. Bram-Cor specializes in designing, engineering, constructing, and validating complete new pharmaceutical facilities. Their services include procuring licenses and know-how transfers, conceptual and detailed engineering, validation planning, equipment installation and testing, training, and regulatory support. They have capabilities across many drug product types including intravenous solutions, dialysis products, blood bags, plasma fractionation, biotechnology, and multipurpose facilities. Bram-Cor aims to provide clients with reliable technologies and ensure their projects meet all applicable regulatory and quality requirements.
Boccard is a global turnkey constructor with over 3000 employees across 18 countries. They have over 100 years of experience in designing, building, and maintaining process facilities for industries like pharmaceutical, food, beverage, and more. Boccard offers full lifecycle services from engineering and fabrication to automation, validation, and long-term maintenance. They have significant experience and references in pharmaceutical and biotech industries for projects like vaccine production, enzyme manufacturing, chromatography systems, and complete turnkey biotech facilities.
This document summarizes PCT's vision and history as a leader in cell therapy manufacturing. PCT aims to make transformative cell-based therapies accessible to all through providing high-quality and scalable manufacturing services. Over 30 years, PCT has gained unprecedented expertise manufacturing over 20 cell therapy products and treating over 6,000 patients. PCT partners with companies from start-ups to large pharmaceutical companies, and aims to guide clients through the entire development and manufacturing process.
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...Merck Life Sciences
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Adherent Lentivirus Suspension Production & Manufacturing.pptxGenScript ProBio
GenScript ProBio is the world's leading biotech company founded in 2002 in New Jersey USA. We at GenScript ProBio provide various solutions based on gene synthesis technology including lentivirus manufacturing, CAR-T IND filing, plasmid manufacturing & production, and many more.
High Quality Integrated Drug R&D Servicesmedicilonz
End-to-end services and solutions covering the entire spectrum of preclinical biopharmaceutical R&D. Supporting everything from target discovery, candidate development, preclinical screening and drug safety evaluation through IND submission. https://www.medicilon.com/about-medicilon/
Bacthera Company Presentation October 2020Felix Faupel
Bacthera is a leading CDMO in live biotherapeutic products (LBPs) with 3 manufacturing sites and expertise in microbiology, processes, and innovation. They provide end-to-end development and manufacturing services from pre-clinical through commercialization. Bacthera was established in 2014 through a collaboration between Chr. Hansen and Lonza combining their complementary LBP expertise.
- Biologics manufacturing is growing rapidly due to increased biologics sales and pipeline products. Biologics are projected to exceed $390 billion by 2020 and nearly reach parity with small molecules.
- Many CMOs are expanding biologics manufacturing capacity through new facilities and production trains featuring single-use technologies and larger bioreactors up to 2000L. Locations include the US, Europe, and Asia.
- Emerging biologics modalities like cell and gene therapies are driving additional manufacturing capacity investments in viral vector production and cell therapy services.
Covering a Spectrum of New Product Development Technologies - From Cells to C...KBI Biopharma
KBI Biopharma provides analytical services, process development, and manufacturing for biologics from early discovery through commercialization. It has locations in Durham, Boulder, RTP, and The Woodlands focused on mammalian and microbial development as well as cell therapy. KBI leverages platform approaches for monoclonal antibodies, bispecific antibodies, fusion proteins, and emerging modalities. It has also partnered with Selexis to utilize their cell lines for development programs and has integrated Selexis cell lines into its platforms to rapidly develop cell lines from DNA to drug substance within 9 months.
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
Therapure Biopharma operates a large cGMP compliant manufacturing facility and can assist with scaling drug production processes up to clinical or commercial levels. They maintain various cleanroom environments and utilities for protein and antibody manufacturing. During scale up, Therapure works closely with clients to refine processes, standard operating procedures, and batch records. They have experience utilizing different sources of API and offer services for upstream, midstream, and downstream protein production including cell culture, purification, filling, and analytical testing.
Dyadic International is developing its C1 gene expression platform to more accessibly and affordably produce biologic vaccines and drugs. C1 uses a proprietary fungal system that offers higher productivity, lower costs, and a faster development timeline compared to the commonly used CHO system. Dyadic has collaborative research programs underway with companies like Sanofi and Mitsubishi Tanabe Pharma to evaluate C1 for producing various biologics. The company aims to license its C1 technology to partners in order to disrupt biomanufacturing and address the growing demand for more affordable biologic treatments.
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.
This document provides an overview of market research services from BioInformatics LLC for companies developing new life science products. It discusses the importance of conducting market research during new product development. Key stages in the product development process include generating ideas, assessing feasibility, development, and product launch. Market research methods that can be used during each stage are described, including focus groups, surveys, and conjoint analysis. Cost-effective options like virtual focus groups and RateMyProduct are also presented for companies with limited budgets.
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Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
3. ◆ Founded in 2010, located in China Medical City
◆ The 1st and Biggest microbial CRTDMO, end-to-end solution provider
in China
◆ 500 team members
Platform:
◆cGMP Production Platform 7500+L, 20, 000+m²plant
◆The largest GMP-level Plasmid supplier in China
◆High-potency Manufacturing Suite
◆Bio-Safety Level 2 (BSL-2) lab for CDO
About Us
Services:
◆ Focus on recombinant proteins, peptides/polypeptides, enzymes,
antibody fragments and nano-antibodies, plasmid DNA and mRNA,
virus-like particle (VLP)…
◆ Meet global customers’ clinical and commercial needs in biological
drugs, biosimilars, vaccines and diagnostics for human and veterinary
use
4. Global Market
Global CDMO Market By Cell Line Type $Million (2021)
Source: www.psmarketresearch.com
CDMO Market Growth Rate by Region (2022-2027)
Source: Mordor Intelligence
20-30%
>50%
5. The First and Largest CDMO in Microbial expression system in
China.
7.18
22.02
26.78
52.52
76
2017 2018 2019 2020 2021
Revenue in 5 years
(RMB, million)
CAGR89%
Position In The Industry
Top 1
Number of
serviced projects
1
1
Top 1
Scale of
production capacity
(7500+L)
6. G27
G29
Vaccine Engineering center
8, 000 m²
, in production
DS Workshop I:50-500L, DS Workshop II:50-200-1000-2000L
DP Workshop I
10, 000 m²
, in production
DS Workshop III:50-100L, DS Workshop IV:50-500L,
DS Workshop V:50-200-500-2000L,
DP Workshop II, Quality Control center
1, 000 m², in production
Process Development Center
G23
3, 000 m², in production
YHNB (IVD), Innovation Center
Existing Capabilities
FDA/EU Industrialization
Standard
Nucleic acid drugs and
Nano-bodies CRO/CDO
Quality research service
Core raw materials
development
Beijing Branch
7. Focusing on the use of plasmid and mRNA,
accelerating the progress
from R&D to clinical application
Recombinant Protein Nucleic Acid Drug Nanobody
End-to-end CDMO service platform for
recombinant protein/polypeptide drugs
Global expression platform
Technical Capacities
Yaohai Bio-Pharma delivers end-to-end biopharmaceutical services, with focuses on recombinant protein, nucleic acid drug and nanobody. With
high efficiency and flexibility, Yaohai provides global biotechnology companies with CDMO services such as process development, IND-CMC
pharmaceutical research, GMP production of clinical samples, registration application, etc., to serve customers with solutions for the whole
process from DNA to commercial production. Yaohai is engaged in providing efficient and feasible CDMO services and solutions to customers
and facilitate the R&D of new drugs.
8. Expression Systems
E. coli
K-12 strains & derivatives (DH1, DH5α,
RV308, W3110, MG1655, JM109, BW25113…)
B strains (BL21, BL21(DE3), BL21(DE3)
pLysS, BL21(DE3) Rosetta…)
Yeast
Pichia pastoris, Hansenula polymorpha,
Saccharomyces cerevisiae, etc.
Yaohaibio has an integrated CMC development and cGMP production process platform to produce recombinant proteins,
plasmids, and antibody fragments with E.coli and yeast expression systems, or the bacterial strains provided by clients.
Tailor constructed Strains
Other microbe/microbiota/microbiome
provided by clients,
Customized strains
10. US-China
application
7
Pre-IND,, 48,
53%
IND, 29, 32%
Phase I, 8, 9%
Phase II, 4,
4%
Phase III, 2, 2%
Pre-IND IND Phase I Phase II Phase III
Based on project phase
Cooperated Projects
Recombinant
protein
55%
DNA plasmid
9%
mRNA
8%
CircRNA
2%
Nanobodies
8%
Vaccine
8%
Recombinant peptide
3%
Recombinant antibody
7%
Based on project type
Recombinant protein DNA plasmid mRNA
CircRNA Nanobodies Vaccine
Recombinant peptide Recombinant antibody
EU-China
application
1
AUS-China
application
2
CAN-China
application
1
11. Strain Construction &
Strain Bank Establishment
➢ Strain construction
➢ GMP secondary strain library
(WCB+MCB) establishment
Process Development
& Optimization
➢ Fermentation process
development & optimization
➢ Purification process
development & optimization
➢ Preparation process
development & optimization
➢ Related product preparation
Method Development &
Quality Control
➢ Quality standards research
➢ Method development & validation
➢ Sample commissioned testing
➢ Stability & compatibility
research
GMP Compliance
Scale-up Production
➢ Fermentation scale-up &
production
➢ Purification scale-up &
production
➢ Preparation production
➢ Preparation of standards
Core Services
12. Workshop Equipment Dosage Form
Specification
Range
Maximum
Output
1500m²Aseptic preparation
workshop in accordance with
GMP requirements for Any
Modalities (biologics,
vaccines, chemicals…)
Filling speed:
2ml vial 160~300 vials/min,
10ml vial 140~200 vials/min
Lyophilization capacity:
2ml 37800 vials (4200 * 9 layers)
10ml 20043 vials (2227 * 9 layers)
Pre-filled injectables
Lyophilized powder injections
Eye drops
Oral solutions
Inhalation formulations
1-25mL
Annual production:
10 million injection (vials)
5 million lyophilized
powder for injection (vials)
Filling and Finishing
13. Strain and cell
banking
Period
Gene synthesis
Plasmid
construction
Strain construction
High-yielding
strain screening
GMP Master Cell
Bank (MCB)
generation
GMP Working
Cell Bank (WCB)
generation
30 days
3 days
3 days
Testing 45 days
Optimization
scale-up
Process
development
Period
Fermentation
development
Purification
development
Sample testing
60-90
days
60-90
days
45 days
Process
confirmation
45 days
Fermentation
Optimization
scale-up
Purification
Optimization
scale-up
Process
confirmation
Analytical
service
Period
Quality
Specification
establishment
Analytical
development
Analytical
method
transfer,
Qualification/Va
lidation
10 days
10-90
days
5-30
days
Sample testing
1-30
days
CTO CDO CDO CMO
Service Process & period
Full
production
Process
Transfer
Period
Fermentation
process
Transfer
Confirmation
Purification
process
Transfer
Confirmation
Formulation
process
Transfer
Confirmation
Depending
on different
process
Release
testing
15-45 days
Fermentation
process
Production
Purification
process
Production
Method transfer
Quality
comparison
Drug
product
Production
Depending
on different
process
Depending
on different
process
14. 1 –Sartorius BIOSTAT C full-
automatic Bioreactor-30L
2 –Quadruple fermentation system
made by Bioengineering AG -7L
3 – GE AKTA System
4 –BIO RAD Gel Imaging System
5 – qPCR made by ThermoFisher
6 –SCIEX capillary electrophoresis;
Equipment For PD
1 2 3
4 5 6
15. High pressure chromatography
High-potency Manufacturing
Suite Hollow fiber system
Sterility Isolator
Equipment For DS Production
Fermentation system 2000 L Disc centrifuge
Automatic buffer
Configuration/storage system
High pressure homogenizer
17. ◆ Extend service chain
◆ Form CRO/CDMO integration
◆ Promote the comprehensive competitive
advantage of technology and scale
◆ Based on the microbiology expression and cultivation
◆ Raw material and CDMO service integration
◆ Give full play to the comprehensive advantages of talent and
microbial track
Strategic Planning
18. 2019 2020 2021 2022
CMO
CDO service
established in 2019
After 2023
Before 2019
CDMO
CDO orders and CDMO orders
increased a lot. Form one stop
service of CDMO
CRO/CDMO
Start to undertake CRO orders in
2022. Form one stop service of
CRO-CDMO service.
Recombinant peptide/protein
mRNA/circle RNA
Domestic GMP
G27 capacity was finished
in 2019
+FDA/EU Commercialization
Industrialization base
Be prepared
for CRO
service in
2021
+FDA pre-phase II
G29 capacity put on operation in 2022 Q1
Existing
orders
Develop Nano-bodies platform process Layout of International production line
Nano-bodies
CDMO service
platform process
development
International orders
contract
CRO platform
construction, business
launch
Business
Model
Global
Standard
Protein
Drugs
Layout of CDMO
service platform
Nucleic
Acid
Drugs
International Marketing
Layout of International Business
Domestic Marketing
Marketing
Strategic Planning
20. Drug Substance Service
Multiple scales of bioreactor
◆ 50L, 100L, 200L, 500L, 1000L, 2000L
20, 000 m²Plant with
GMP standard, including four areas
◆ Strain area (C level)
◆ Fermentation area
(D level)
◆ Purification area
(C level)
◆ Explosion-proof area
(C level)
21. Drug Substance Service
Strain Bank
Establishment
within GMP
system
Pilot-scale
Process
Optimization,
Scale-up and
Production
Production of
Sample
Preparation
Batch for IND
Registration
Application
Sample
production for
Phase I-III
Clinical Trial
FDA/NMPA
Industrialized
Production
Standards
Preparation
22. Preparation products of
injection/ lyophilized powder for
injection(vials)
1
2
3
Drug Production Experience
IND sample preparation
Clinical Phase I-III sample production
MAH consigned production
Meets the requirements of sterile
drug product of China NMPA, EU
EMA, and US FDA
Services Experiences
Product Categories:
Peptides
Proteins
Plasmids
Recombinant vaccines
Other standard drug products
Project Phases:
pre-IND
IND
phaseⅠ
phaseⅡ
phaseⅢ
23. RNA structure design and
optimization platform
RNA Synthesis and
Modification Platform
RNA purification platform
RNADes RNASyn
RNAPur RNAQua
RNA quality analysis and
control platform
Research Platform
“RNASci“ mRNA & circRNA research-grade sample preparation service platform
The platform contains four major technology modules: RNADes (RNA structure design and optimization platform), RNASyn (RNA synthesis and
modification platform), RNAPur (RNA purification platform), and RNAQua (RNA quality analysis and control platform), which run through the
whole lifecycle of circRNA design to sample formation.
24. Scientific research level sample preparation service of mRNA
The outbreak of the COVID-19 in 2020 has pushed the mRNA technology to the center of the stage, and the related research is
unprecedentedly popular. It has developed rapidly in infectious disease prevention, tumor treatment, protein replacement therapy, regenerative
medicine, cell therapy and other fields. YaohaiBio has launched the “RNASci” mRNA scientific research level sample preparation platform,
providing one-stop services for mRNA preparation, which runs through the whole life cycle from mRNA design to sample preparation, and
comprehensively energizes the research and development of mRNA vaccines and drugs.
Research Platform
Sequence
design and
optimization
transcription template
plasmid preparation
in vitro
transcription
purifica
tion
Enzyme method
capping
purification
lyophili
zation
Entrap-
ment
Delivery
co-transcribed
capping
Quality analysis and
control
mRNA in vitro Preparation
25. 06
01
02
03
04
05
CYTOKINE
VLP
NANOBODY
mRNA
RECOBINANT
PROTEIN
RECOBINANT PROTEIN
development platform
• 50+ projects
• 92%+successful historical delivery rate
• Platform-based screening process
Development Platform
NANOBODY development platform
• Full-ecological recombinant expression system of E. coli,
yeast, mammalian cell
• Multi-valent:monovalent, bivalent, trivalent
• High Yield:up to 8g/L
mRNA development platform
• Customized sequence design &
optimization
• Multiple mRNA pre-products on sale,
such as EGFP
• 15+cooperative partners including
universities, enterprises, institutions
PLASMID
PLASMID development platform
• 20+ multi-category projects, including bare
plasmids, mRNA templates, gene therapy
materials, vaccines
• Experienced in industrialization: 2
clinical phase III projects
VLP development platform
• Experienced in vaccine development
• Multi-valent:bivalent, tetravalent,
9/15-valent
• Multi-category: virus, phage,
CYTOKINE development platform
• Specialized teams for list of strains
• 7 related project experiences, involving
interleukins, interferons, thymidine,
insulin and its analogues, etc.
27. Bacteria Pellet
preparation
Pilot-Scale Service
Fermentation pilot-scale
process development &
validation (30L/ 69L)
Purification pilot-scale
process scale-up &
validation
Purification
sample
preparation
SERVICE
E.coli
&
Yeast
FERMENTATION
PURIFICATION
VLPs
PLASMID
RECOMBINANT
PROTEIN
NANOBODY
28. R&D QA Department
▪ The review of record files, the control of process exceptions
and changes, make the process of the entire R&D project
traceable.
▪ R&D record management to ensure the authenticity and
reliability of the original records.
▪ The whole process of quality management and risk
management of R&D experimental projects ensures the
implementation of the R&D quality system and the
continuous improvement in the later stage.
Registration Compliance Department
▪ Responsible for the review and approval of drug registration
materials for CRO projects, including biopharmaceutical new
drug applications, various supplementary applications, etc.
▪ Assist R&D to standardize various experimental projects
from the perspective of registration
▪ Responsible for communicating with clients of entrusted
projects and following up on various entrusted trials related
to drug registration
Scientific and efficient R&D Quality Management Unity of responsibility and power
Quality Management
29. Document/ Records
Management Instrument/Equipment R&D site management Process supervise & control
1. Review documents and records
as required to ensure the
uniqueness of all plans, reports,
records and ledger numbers in
the R&D process;
2. Supervise the writing and filing of
records, establish a complete
variety file, and provide data
support for later reporting.
1. According to the specific
use of the equipment, the
equipment is managed by
grades;
2. Regular measurement
and verification to ensure
the accuracy of all
experimental data
1. R&D QA regularly conducts on-site
inspections of experiments to ensure the
integrity of equipment, on-site operations,
and instrument use records;
2. Do a good job of cleaning management
on site according to the document
requirements;
3. Material control: can control different
materials according to the requirements of
laws and regulations.
1. Investigate the abnormal situation
in the process of research and
development in time and record it
completely;
2. Changes generated in the research
and development process,
according to the specific situation
of the assessment change, confirm
that it is enough to change the
process
Regular on-site inspection
Abnormality,
change
& other documents
Quality Management
30. Quality System Testing Capability
分类
分类
Category Biochemical Testing
Physicochemical
Testing
Microbiological Testing
Items
Expression of target product Appearance Plasmid Loss Rate
Digestion Profile of Plasmid PH LB Plate Streak
Protein Content Visible Impurity Resistance to Antibiotics
Purity Loading Capacity Biochemical Reaction
Molecular Weight Insoluble Particles Antibiotics Residues
Activity Testing Osmotic Pressure Bacterial Endotoxin
Exogenous DNA Residues Water Content Microbial Limits
Host Bacteria Protein
Residues
Asepsis
Isoelectric Point
Ultraviolet Spectrum
Peptide Mapping
Identify
30 testing items and 50 testing methods
are used in routine items testing.
31. Registration Service
With the experienced drug registration application service team, Yaohaibio provides high-qualified, efficient and accurate registration services including IND/BLA
application home and abroad, CMC consultation, registration application strategy guidance, preparation and submission assistance in CMC-related CTD documents,
communication assistance with official authorities, on-site inspection guidance, training and conference on drug registration regulations organization. The core
members of the registration team have abundant registration experience, in-depth understanding of registration-related regulations in China and aboard, and provide
comprehensive guidance on regulations and strategy in full life cycle of product development.
Preparation Of
Application
Documents
Preparation Of
Application
Documents
On-Site
Inspection
Regulatory
Support Matrix
Other Value-
Added And
Special
Services
Registration
Service
32. Registration Service
Registration Service
Preparation Of Application Documents
• Committed To CMC Regulatory Consulting Services
• Provide Guidance On CMC Strategy Making And Gap Analysis For Domestic And International
Registration Applications
• Assist In Communicating With Regulatory Authorities, Responding To Approval Comments And Submitting
Supplementary Documents
• Assist In Communication On Matters Related To Registration And Inspection
• Assist In The Collation, Review, Filing, Binding, Submission, Etc. Of Registration Application Documents
• Organize Meetings, Including CDE Consulting Meetings Of Types 1, 2, And 4 As Well As Other Meetings
(Including The Submission Of Meeting Requests, Preparation Of Meeting Documents, And Attend The
Meeting To Assist The Customers In Communicating With The Regulatory Authorities)
• Preparation Of IND And NDA Application Documents
• Flexible And Customizable Registration Application Document
Preparation Service
33. • Research On Regulations From Drug Regulatory Authorities Worldwide
• Regulatory Strategy & Implementation Guidance
• Sorting And Interpretation Of General Regulations And Individual Regulations
• Year-Round Routine Regulatory Consultation
• One-To-One Regulatory Consultation
• Project Management
Registration Service
On-Site Inspection
Regulatory Support Matrix
Other Value-Added & Special Services
• Review Of Guidance On The Documents Preparation
• On-Site Review Of Guidance On The Drug Registration
• Project Demonstration During Project Technology Development Or Transfer
• Analysis Of IND/NDA Application Strategy
• Research And Assessment Of Special Varieties
34. Professional Team
The core members have rich experience in drug registration
and project management for over 10 years.
Multi-module expertise, numerous professional operation
experience, and strong professional support from domestic and
foreign experts.
Abundant Project Operation Experience
Served more than 200 customers
Pre-evaluate the difficulties of projects and improve project
efficiency significantly on the back of
abundant project experience and skilled understanding of
regulatory guidelines, review requirements
and drug registration points.
Registration Service Advantage
Real-time Information Sharing
Familiar with every communication channel of official
authorities
Regularly collect the latest regulatory trends
Fully understand the laws and regulations
Share the information after integration and analysis with a
powerful regulatory database and document template
database.
Full Life Cycle Service Management
One-stop service chain, covering the establishment of R&D
system, IND and NDA application, project management
Implement the full lifecycle of drugs management concept in
the full course of the project.
Project Management Improvement Service
Provide full life cycle planning and guidance service and feasible
suggestions, focus on risk management and budget control, formulate
practicable solutions to ensure project quality.
35. Registration Experience
80+ application strategies
for protein-based drugs
50+ application strategies
for gene-based drugs
100+ on-site inspection
guidance
200+ compliance
guidance during R&D and
manufacturing