Mar 08, 2021 (Market Insight Reports) -- Selbyville, Delaware, Market … A surge in demand for viral vector manufacturing has been driven by a swelling of new product candidates pushing to enter clinical development and an increasing number of candidates needing 100-fold or more clinical vector for diseases requiring systemic … Industry experts cite their personal experiences where project directive changes in stick-built facilities, such as changes to the room architecture to support new process demands, were accommodated during the mid-construction phase. 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Email: sales@marketindustryreports.com The latest innovations combine low-shear operations and fully closed processing to allow the highest recovery with full containment – creating an ideal environment for viral … The design and age of the building would also need to be considered as these may result in upgrade inflexibilities. Through ongoing efforts, Brammer Bio and Pall Biotech are each developing and implementing state-of-the-art … Thus, the rising prevalence of chronic diseases during the forecast period will contribute to the growing global demand for viral vectors at a CAGR of over 15 percent. The model consists of a pre-fabricated facility that can be repurposed or moved to another location, depending on business needs, thus providing companies with a great degree of flexibility in moving manufacturing sites. We offer one of the world’s most comprehensive viral vector technology platforms based on lentiviruses, adenoviruses, and adeno-associated viruses (AAV). At the beginning of 2016, the company had one filling suite, one drug substance suite for adherent cell … In finalizing the design for viral vector manufacturing facilities, there are really only two major considerations for companies: time and cost. The Viral Vector Manufacturing Market is segmented on the basis of Product, Modality, Cancer Type, End-Users and region. 6 Viral Vector Manufacturing Market, By Type (Page No. So, with optimization and standardization of manufacturing design and facility as the end goal, there are various evaluation criteria and industry trends that could play a key role in reaching the set goals. To produce viral vectors, the appropriate cells must first be grown and then transfected, typically using a plasmid formulation. The product portfolio of the gene therapy market is also set for a major expansion over the next five to ten years, which would require the bio-manufacturing industry to be well-equipped to meet the increased demands from the gene therapy market and enable biopharmaceuticals to successfully commercialize the products. Simplistically, the AAV vector is a delivery vehicle for a therapeutic gene, and the manufacturing process is not linked to that gene. The Global Viral Vector & Plasmid DNA Manufacturing Market is expected to grow from JPY 73,472.92 Million in 2020 to JPY 224,478.60 Million by the end of 2025. Novasep's viral vector manufacturing business provides contract manufacturing services for vaccines and therapies to biotechnology companies and large biopharma customers. Cell-bank and viral-vector testing have a strong focus on adventitious agent testing, specifically when using FBS or other animal-based materials in the manufacturing process. (46,47). 20(8) 2009: 861–870. So, the demand for viral vector manufacturing facilities that can cater to the needs of pre clinical, clinical and commercial development of gene therapies is only expected to increase exponentially year on year over the next decade. Market Industry Reports is a global leader in market measurement & advisory services, Market Industry Reports is at the forefront of innovation to address the worldwide industry trends and opportunities. https://www.marketindustryreports.com/inquiry/365, Buy this report @  • Creative Biogene A major bottleneck for viral vector vaccine production is scalability. Upstream process development. March 9th, 2021 Market Industry Reports Releases. At our Viral Vector Core, we use state-of-the-art equipment, time-tested techniques, and advanced design concepts to provide our viral vector development and manufacturing services. Adoption of single-use technologies throughout viral vector manufacturing will lead to speed to market, increased process flexibility and facility utilization as well as reduced overall costs. The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy. Website: https://www.marketindustryreports.com. Scale-up of … Global Viral Vector & Plasmid DNA Manufacturing Market - Scope of the Report. Adenoviral Vectors, Retroviral Vectors, and Adeno-associated Viral Vectors, By Disease Indication: Scalable Recombinant Adeno-Associated Virus Production Using Recombinant Herpes Simplex Virus Type 1 Coinfection of Suspension-Adapted Mammalian Cells. https://www.marketindustryreports.com/checkout/365. Bioprocess. Further, in this type of delivery method, companies would need to minimize design changes to ensure financial savings, and any significant design changes that are accommodated may result in a construction delay and an increase in associated costs. Traditionally, viral vectors are grown in cells that are attached to a substrate, rather than in free-floating cells - but this is difficult to do on a large scale. Standardization should be a major consideration, especially for companies building manufacturing sites in multiple regions, as the facilities can then be replicated while also improved upon simultaneously to support smoother technology transfer, procedure development and staff training. Thanks most kindly for your help. 7 Viral Vector Manufacturing Market, By Disease (Page No. Cost-effective but a long lead time: While stick-built facilities are typically the least expensive, they also take the longest to build. The first major challenge presented by these growing industries is the readiness for largescale manufacturing of viral vectors. From new customer bases and vaccines to biosimilars and antibodies: what are the emerging trends and hot topics in biopharma, and how can companies take advantage of them in order to succeed? Industry best practices: Industry experts agree that the closed and automated suspensionbased cell culture systems provide a plethora of advantages such as greater predictability, easier scalability platform to support both developmental and commercial manufacturing scale, and accelerated timeline for manufacturing and release of gene therapies. We use cookies to ensure that we give you the best experience on our website. We offer a broad range of pre-clinical and clinical manufacturing services for viral vector products. 22(8) 2011: 913–915. We have performed more than 50 viral vector projects for large pharmaceutical companies, biotechnology companies and non-profit organizations with superb customer satisfaction. The first part of this article deals with the production of the most important viral vectors … This paper outlines five impactful trends and criteria that will influence the future of viral vector manufacturing. Companies will have to make smart decisions regarding the options they choose based on their project budget and the timeline by which companies initiate their product supply line. By Type: Vaccinology andGene Therapy, By End-User: Participants included: Carol Houts, vice-president of quality and business strategy, Germfree; Peter Walters, advanced therapy medicinal product subject matter expert, CRB; Ryan McDonough, PE, senior vice-president of project operations, DPS; Steve Gravallese, program director, Cytiva; and Joseph Makowiecki, director of business development, Cytiva. Additional benefits include safer construction with work performed in a more controlled environment, less time and less contractors on the jobsite, less material waste due to a more controlled inventory, and a structurally stronger product in order to withstand the rigors of transportation and installation. ” He highlighted the features of his company’s gene therapy manufacturing processes based on HEK293 suspension/plasmid transfection and HeLa producer cell line (PCL) suspension/adenovirus helper platforms. ABL Europe is a contract manufacturing organization that is 100% dedicated to viral vector production. Cells may be genetically modified either in vivo or ex vivo. Not only does this pose a challenge in terms of available incubator space, the manipulat… Faster deployment model with a standardized design: The fully modular facility concept is expedited over a stick-built facility to facilitate faster delivery and potentially better  quality. For regulatory compliance, products intended for therapeutic use should be well characterized and manufactured to high purity, efficacy, and safety, and high levels of GMP compliance should be met. Product release and regulatory support. Fujifilm will invest 4 billion yen ($40 million) to build a new manufacturing facility for viral vectors in Watertown, Massachusetts, the company said Monday. We have extensive experience in manufacturing a wide range of viral vectors including AAV, adenoviruses, lentiviruses, measles virus and VSV. With growing interest around viral vectors and their widespread adoption by biopharmaceutical industries, there is an imperative on engineering safer & more efficacious vectors and cost-effective production platforms for industrialization. There remains a clear need for improved process productivities, and the need to develop manufacturing processes that can be applied to a wide number of AAV-based viral vector therapeutic candidates. • Merck KGaA Viral vector track record. Manufacturing of viral vectors for gene therapy: part I. Upstream processing 2 2 2014 For reprint orders, please contact reprints@future-science.com. Glybera®, which contains an AAV1 vector for treatment of patients with lipoprotein lipase deficiency [2]. The Global Viral Vector & Plasmid DNA Manufacturing Market is expected to grow from JPY 73,472.92 Million in 2020 to JPY 224,478.60 Million by the end of 2025. Novasep's viral vector manufacturing business provides contract manufacturing services for vaccines and therapies to biotechnology companies and large biopharma customers. The adoption of suspension-based cell cultures will result in a more simplified and scalable process and one which can easily leverage existing single-use stirred tank bioreactors that have been utilized and optimized by the industry over the past 15 years. If you continue to use this site we will assume that you are happy with it. Although biopharmaceutical contract development and manufacturing organizations (CDMOs) specializing in viral vector manufacturing can help, they are expected to be functioning at near capacity. We have generic viral vector protocols present to produce, purify, test and release measles-, AAV-, lentiviral-, adenoviral-, or VSV-based vector products, and specific protocols for diverse serotypes. The MarketWatch News Department was not involved in the creation of this content. We operate BSL-2 R&D and GMP manufacturing facilities. Chasing the Biopharma Market Free Whitepaper The GMP facility is equipped to run up to 200 L mammalian cell line-based processes and is fully licensed to manufacture viral … Frost & Sullivan estimates the gene therapy market will reach $22.7 billion by 2024, growing at a 38.0% CAGR. Gene and viral-vector-modified cell therapies are areas of development generating tremendous excitement in the pharmaceutical industry today. Global Viral Vector & Plasmid DNA Manufacturing Market - Scope of the Report. With two locations in Seneffe and Gosselies, Belgium , Novasep's viral vector business offers more than 7,000 square meters of state-of-the-art clinical and commercial manufacturing capacity. Most viral vector manufacturing approaches for initial clinical use were developed in academic settings. To alleviate the industry bottleneck for Viral Vector Supply, we invested significant resources to develop a production platform that delivers QC tested and released GMP lots. To ensure environmental safety, proper channels of waste streams and inactivation should be accounted for in the design. Viruses have evolved specialized molecular mechanisms to efficiently transport their genomes inside the cells they infect. 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By product, the viral vector topical segment accounted for the largest viral vectors and plasmid DNA manufacturing market share in 2019, and is expected to maintain its dominance during the forecast period, owing to the necessity and applicability of these products in different research interventions. Delivery of genes, or other genetic material, by a vector is termed transduction and the infected cells are described as transduced. Pro10™ cell line is derived from HEK293 cells and show high yields across a wide range of serotypes, multiple chimeric, and novel capsids. Companies would need to assess the necessary structural and mechanical, electrical, and plumbing elements prior to lease or purchase. Suspension cell lines are now being developed, which would enable viral vectors to be grown in large bioreactors. var iframe =document.getElementById('vmsiframe'); With two locations in Seneffe and Gosselies, Belgium, Novasep's viral vector business offers more than 7,000 square meters of state-of-the-art clinical and commercial manufacturing capacity. The Viral Vector Manufacturing Market is segmented on the basis of Product, Modality, Cancer Type, End-Users and region. Contact Us- RELATED: $50M cell and viral vector manufacturing operation backed by Harvard. Viral Vector Manufacturing SIRION Biotech custom engineers and manufactures viral vectors for R&D and preclinical testing. Join us and see the progress in real time. The majority of gene therapy applications in development utilize viral vectors to carry the therapeutic gene into the target cells. For instance, key industry experts point out that if a BSL- 1 monoclonal antibody manufacturing facility is to be retrofitted, the respective HVAC designs that are focused on particulate filtration, recirculation zones and cascade pressurization schemes need to be realigned to promote segregation and containment with design elements such as single-pass air, pressurization bubbles and sinks. Also, the inability to source critical materials rapidly is heavily impacting emerging gene therapy companies, both schedule-wise and financially. Another big problem is that some of the proteins associated with viruses are actually toxic to the cells that produce them, and it means that you have a very short window of production before all of your producer cells start to die. With two locations in Seneffe and Gosselies, Belgium , Novasep's viral vector business offers more than 7,000 square meters of state-of-the-art clinical and commercial manufacturing capacity. In addition, testing for replication competent viruses is required for manufactured viral-vector lots to ensure no infectious lentivirus was generated via recombination events during the manufacturing process. 184 Pharm. Gene Ther. The disadvantage of this type of facility is that the design may be limited to the capabilities of what the modular systems can provide. Further, the design considerations for a viral vector manufacturing facility should also accommodate decontamination of cleanrooms, requiring, stainless HVAC ducting, bubble-tight dampers, dedicated air handling units (AHU) zones and single-pass air. The design optimization and standardization that have taken place for the manufacturing of monoclonal antibodies represent the gold standard that viral vector manufacturing needs to strive for. Clive Glover, senior global marketing manager, cell and gene therapy, of Pall Corporation, said the industry is now building a lot of capacity, but continuous manufacturing would be the ultimate answer to the problem of viral production. We will also collect and use the information you provide for carefully considered and specific purposes, where we believe we have a legitimate interest in doing so, for example to send you communications about similar products and services we offer. According to the National Institutes of Health, “Gene Therapy is an experimental technique that uses genes to treat or prevent disease.” Gene therapy is a novel therapeutic area that may involve the insertion of a new gene or knock down an existing gene. Such technological advances need to be embraced by the industry to advance the viral vector manufacturing industry. Dear reader, since you choose to block our ads, please click here to help support Medgadget. Importantly, this can result in financial benefits for companies as they provide a reduction in the price per square foot of the shell building. Hum. The benefits of single-use technologies for traditional mAb production are well known in the industry. Th… Cobra has been a manufacturer of GMP viral vector products for gene therapies and viral vaccines since 2002 and more recently immuno-oncology therapies. Viralgen Vector Core has licensed the Pro10™ cell line and manufacturing process from Askbio. 1 March 2021 (Last Updated March 2nd, 2021 14:52). By clicking the “Submit” button above, you accept the Terms & Conditions and acknowledge that your data will be used as described in the Cytiva Privacy Policy. Moreover, viral vectors and plasmid DNA can reduce cost of treatment and help decrease repeated administration of medications. Eventually, these companies will face a costly decision to raise funds and invest in a development and manufacturing facility for viral vectors or incur premium costs for collaborations with specialty bio-CDMOs for viral vector manufacturing. Downstream processing & safety aspects 2 3 2014 Manufacturing of viral vectors comprises the generation of these vectors, which then have to be purified in order to meet the quality attributes required for further use as gene delivery systems. The growth of the viral vector manufacturing market can be attributed to several factors such as increased incidences of infectious diseases, increased utilization of viral vectors to develop gene therapies and vaccines, and increased support & investments in gene therapies and vaccines. This is because viral vectors are a promising method for vaccine production and gene therapy. Viral vector manufacturing. Viral vectors are tools commonly used by molecular biologists to deliver genetic material into cells. Research Institutionsand Pharmaceutical & Biopharmaceutical Companies, Have any query? Assembling the vector vaccine is also a complex process, involving multiple steps … Primary considerations that are critical to the process would be the design and condition of the existing shell building and utility infrastructure, followed by the conversion of the existing facility to accommodate the appropriate biosafety and room classification requirements. 2 3 2014 Manufacturing of viral vectors comprises the generation of these vectors, which then have to be purified in order to meet the quality attributes required for further use as gene delivery systems. Some of the thought leaders strongly expressed that the box-in-box model can optimize a facility footprint by taking advantage of vertical space, thus reducing an overall facility footprint. Market Industry Reports (MIR) has published a new report titled “Viral Vector Manufacturing Market– Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019–2030.” According to the report, the global viral vector manufacturing market accounted for over US$ 350 million in 2019. Containment zones should be identified based on the guidance from cGMP and biosafety in microbiological and biomedical laboratories (BMBL) 5th edition biosafety standards. In October 2020, Fujifilm announced it planned to open a gene therapy facility in the UK in spring of 2021. With both in-vivo and ex-vivo (e.g., CAR-T) gene therapies predominantly leveraging viral vectors (lentivirus and AAV majorly) for the gene transfer mechanism, the global manufacturing bottleneck of viral vectors that currently exists can affect many companies worldwide and even slow down the distribution of any successful viral vector based vaccines. Medical technologies transform the world! 40 Thomas DL, et al. In addition, Frost & Sullivan estimates the potential launch of 20-25 gene therapy products over the next five years. Any resulting batch failures may compound the problem of increasing lead times for biopharmaceutical companies relying on the bio-CDMOs. Read more . As these factors have an inversely proportional relationship, companies must have a clear understanding and plan in terms of their requirements and designs to optimize the timelines and costs involved in building a facility. Viral vector manufacturing track record. Viral Vector Development and Manufacturing Sam Wadsworth presented “Next-Generation Cell Line Development for AAV Gene Therapy Products. Strategies to address the viral vector manufacturing shortage, Viral vector manufacturing: design considerations to improve commercial success. To determine the best delivery method of a facility, companies need to assess the two driving factors: time and budget. By nurturing the perception of genius and optimized market intelligence we bring proficient contingency to our clients in the evolving world of technologies, megatrends and industry convergence. We offer a broad range of clinical manufacturing services for replication-competent or incompetent viral vectors. The utilization of viral gene transfer vectors has expanded due to the acceptance of treatments, the introduction of late-stage clinical trials to treat genetic defects & various types of cancer, and the need for vaccinations to prevent infectious diseases. “A major factor for determining the best delivery method is determining how fast you need the facility and what degree of change will be needed to continue to make throughout design to match your evolving process,” says Peter Walters, Advanced Therapy Medicinal Product, Subject-Matter Expert-CRB. - 31) 6.1 Introduction 6.2 Retroviral Vectors 6.2.1 Lentiviral Vectors 6.2.2 Gamma-Retroviral Vectors 6.3 Adenoviral Vectors 6.4 Adeno-Associated Viral Vectors 6.5 Other Viral Vectors . Substantial improvements in vector manufacturing, delivery, and safety have placed viral vector-based therapy at the forefront of modern medicine. Get sample copy of “Viral Vector Manufacturing Market” at:  Exothera is a Belgium-based CDMO delivering customized process development and GMP manufacturing services for gene therapy and viral vector-based vaccines.As a Univercells company, Exothera capitalizes on novel manufacturing technologies and best-in-class bioprocessing expertise to provide bespoke process optimization and GMP clinical and commercial production of viral vectors. They argue that stick-built models are probably the only delivery method that can support such changes since studs and drywall have essentially no lead time to produce. Downstream process development. Embracing the concept of standardizing facility design and incorporation of good design practices will result in a faster design cycle, increase the probability of regulatory approval, create more consistent operations and, ultimately, provide better quality and service for the end users—the patients. iframe.src =iframe.src +window.location.search; From new customer bases and vaccines to biosimilars and antibodies: what are the emerging trends and hot topics in biopharma, and how can companies take advantage of them in order to succeed? In collaboration with Bayer, the … We empower and inspire Vanguards to fuel and shape their business to build and grow world-class consumer products. Another option for building a viral vector manufacturing facility is to retrofit an existing space environment or a completely re-purposed facility to be suitable for viral vector production. ‐ Concurrent manufacturing of multiple batches of the same vector product in the same suite with appropriate line clearance between operations ‐ Only one batch can be openly processed at a time in an ISO 5 BSC Case Study #1 Multi-Viral Vector Manufacturing Facility www.fda.gov 10 Viral Vector Manufacturing Market, By Region (Page No. The advantages of a fully modular system are that the qualification, testing and documentation of equipment and facility can be accelerated before the facility reaches the factory site. To ensure that safety and quality are at the forefront of design considerations, the justification of design decisions should be heavily based on a robust risk assessment carried out at the manufacturing site under a quality risk management program. • uniQure The design considerations for such a process may involve a number of challenges. “Some of the major challenges with manufacturing viral vectors are the segregation and biosafety level requirements associated with the facilities,” says Ryan McDonough, Senior Associate, Biotechnology Core Team Leader-CRB. Pro10™ cell line is derived from HEK293 cells and show high yields across a wide range of serotypes, multiple chimeric, and novel capsids. Fujifilm has a viral-vector facility in College Station, Texas, that opened in 2014 and was further expanded with a $120 million investment to increase manufacturing capacity. Owing to the growing demand for novel therapeutics to deal with life-threatening diseases, such as cancer, various smaller companies are also entering the market and holding a significant … This model provides significant advantages for companies that want to adapt their manufacturing platform in the future without significant facility disruption. In addition, the largescale operations may require HEPA filtration of the exhaust airflow at higher biosafety levels, which most companies design as bag-in bag-out in accordance with NIH requirements. In recent years, we have witnessed a sharp increase in the number of gene therapies in pre-clinical and clinical studies, suggesting an exciting trend pointing to the possible emergence of treatments for medical conditions such as Hemophilia B, Spinal Muscular Atrophy, Muscular Dystrophy, thalassemia, etc. The major benefit with the box-in box model is an optimized schedule – “Speed Wins.”.