Making Predictions by Digitizing Bioprocessing

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech.
“Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says.
Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects.
“The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.”
To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

Spotlight

Roslin BioCentre

Situated on the South side of Edinburgh, Roslin BioCentre is a 'Centre of Excellence' for Life Sciences and the location of choice for a wide variety of Life Science Companies. Roslin prides itself on an unrivalled ability to cater for the needs of both office and lab-based organisations by providing flexible, affordable accommodation for a range of companies located on site.

OTHER ARTICLES
MedTech

2022 U.S. Market Research Report with COVID-19 Forecasts2

Article | July 11, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

Read More
MedTech

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | July 12, 2022

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

Read More
Research

Nanostructures: Emerging as Effective Carriers for Drug Delivery

Article | July 11, 2022

Natural remedies have been employed in medicine since antiquity. However, a large number of them fail to go past the clinical trial stages. In vivo instability, poor solubility and bioavailability, a lack of target-specific delivery, poor absorption, and side effects of the medication are only a few of the problems caused by the use of large-sized materials in drug administration. Therefore, adopting novel drug delivery systems with targeted medications may be a solution to address these pressing problems. Nanotechnology has received tremendous attention in recent years and has been demonstrated to help blur the boundaries between the biological and physical sciences. With great success, it plays a vital part in enhanced medication formulations, targeted venues, and controlled drug release and delivery. Limitations of Traditional Delivery Trigger the Adoption of Nanoparticles The field of nanotechnology and the creation of drug formulations based on nanoparticles is one that is expanding and showcasing great potential. It has been thoroughly researched in an effort to develop new methods of diagnosis and treatment and to overcome the limitations of several diseases' current therapies. As a result, nanoparticles are being used to improve the therapeutic effectiveness and boost patient adherence to treatment by increasing medication bioavailability, drug accumulation at a particular spot, and reducing drug adverse effects. The nanoparticles could be transformed into intelligent systems housing therapeutic and imaging agents by manipulating their surface properties, size, correct drug load, and release with targeted drug delivery. Nanostructures facilitate the release of combination medications at the prescribed dose since they remain in the blood circulation system for a long time. Therefore, they result in fewer plasma fluctuations with decreased side effects. Due to their nanoscale, these structures can easily enter the tissue system, promote the absorption of drugs by cells, make medication administration more effective, and ensure that the medicine acts at the targeted location. The Way Ahead Nanomedicine and nano-delivery systems are a comparatively new but fast-evolving science in which nanoscale materials are used as diagnostic tools to deliver drug molecules at precisely targeted sites in a controlled manner. It is finding applications for the treatment of diseases such as cardiovascular, neurodegenerative, cancer, ocular, AIDS, and diabetes, among others. With more research and technological advancement, these drug delivery solutions will open up huge opportunities for companies that work with them.

Read More
MedTech

Biotech in 2022

Article | July 11, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

Read More

Spotlight

Roslin BioCentre

Situated on the South side of Edinburgh, Roslin BioCentre is a 'Centre of Excellence' for Life Sciences and the location of choice for a wide variety of Life Science Companies. Roslin prides itself on an unrivalled ability to cater for the needs of both office and lab-based organisations by providing flexible, affordable accommodation for a range of companies located on site.

Related News

Medical

Flagship Pioneering Announces the Merger of Two Leading Programmable Medicine Platforms to Form Sail Biomedicines

PR Newswire | October 25, 2023

Flagship Pioneeringannounced the combination of Laronde and Senda Biosciences to launch Sail Biomedicines, a company pioneering the design and deployment of fully programmable medicines to transform patient care. Sail harnesses the power of first-in-category programmable payloads of Endless RNA™ (eRNA), first-in-category programmable nanoparticles, and emerging, proprietary AI technologies, to unlock the comprehensive programming of medicines for the first time. Guillaume Pfefer, Ph.D., MBA, who is also CEO-Partner at Flagship Pioneering, will become Sail's CEO and board member, while John Mendlein, Ph.D., who also serves as Executive Partner, Flagship Pioneering, will become the company's Executive Chairman. Sail unites Laronde and Senda Biosciences, two companies that deliver more than eight years of combined data and multi-product platform building. Senda's platform was the first to leverage a universal chemical code of natural nanoparticles that enables directed and repeatable deployment of payloads, such as translatable RNA, directly to cells and tissues of choice. Laronde pioneered eRNA, a new class of synthetic, translatable RNA that can be programmed to express diverse proteins inside the body, with vast therapeutic potential. "Endless RNA has the potential to create an entirely new class of programmable medicines across therapeutic areas that we will now be able to deliver directly to cells and tissues via deployment molecules with unique properties to confer specificity and greater tolerability," said Mendlein. "We believe these programmable medicines will be greatly enhanced via our proprietary generative AI technologies and rapid prototyping abilities to achieve breakthroughs currently beyond the grasp of the human mind. I look forward to working with the Sail Biomedicines team in this exciting new chapter." "Our deployment platform utilizes natural nanoparticles to shuttle biomolecules into human cells, with unique tropism, potency, and redosability," said Pfefer. "I look forward to leading the integration of these two teams to accelerate the development of new product candidates, build strategic partnerships, and enable diverse value pools, with the goal of swiftly delivering life-changing vaccines and therapies for the people who need them." "Sail Biomedicines builds on the progress made by two leading Flagship bioplatform companies and will enable integrative design for more effective programmable medicines," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering. "I am confident the combined leadership team and board will carry forward this company to realize its bold ambitions and ultimately deliver maximum impact for patients." In addition to Mendlein and Pfeffer, the Sail Biomedicines Board of Directors will comprise all current members of the Laronde and Senda Biosciences boards, as follows Pablo Cagnoni, M.D., President and Head of Research & Development, Incyte Jose "Pepe" Carmona, MBA, Chief Financial Officer, ADC Therapeutics Paula Hammond, Ph.D., Institute Professor, Massachusetts Institute of Technology, Head of Department of Chemical Engineering, Massachusetts Institute of Technology Avak Kahvejian, Ph.D., General Partner, Flagship Pioneering Ignacio Martinez, MBA, General Partner, Flagship Pioneering Sheri McCoy, M.S., MBA, Former Vice Chairman, Johnson & Johnson Mary Szela, MBA, CEO and President, TriSalus Life Sciences About Sail Biomedicines Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail's platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of generative AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering. About Flagship Pioneering Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. To date, Flagship has deployed over $3.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $26 billion of follow-on investments from other institutions.

Read More

Medical

Integrated DNA Technologies Opens New Therapeutic Manufacturing Facility to Support Growing Demand in Genomic Medicine

businesswire | October 19, 2023

Global genomics solutions provider Integrated DNA Technologies (IDT), an operating company in the Life Sciences segment of Danaher Corporation announced the completion of its new Therapeutic Oligonucleotide Manufacturing facility in Coralville, Iowa. The milestone marks a significant achievement in the company’s 35-year-history—its entrance into the therapeutics space—and enables IDT to manufacture products for research use through to current good manufacturing practice (cGMP) grade cell and gene therapy reagents to provide researchers with a single partner that can help them rapidly transition from the lab to therapeutic development. The 41,000-square-foot-site will produce cGMP cell and gene therapy reagents, including single guide RNAs (sgRNAs) and donor oligos for homology-directed repair (HDR) with additional offerings to follow. These new capabilities and offerings will be supported with comprehensive documentation and testing, a support team, and regulatory guidance to help accelerate researchers’ path to the clinic. “An increasing number of customers are seeking out IDT as a trusted partner for their CRISPR genome editing needs, and are asking us to be the provider that can help them bridge the gap from lab to clinic,” said Demaris Mills, president, IDT. “Now, with our new cGMP manufacturing facility, IDT can provide a complete CRISPR workflow—from design to analysis—that supports cell and gene therapy developers in all stages of therapeutic development, with the same support and expertise they have come to know from IDT. These new manufacturing capabilities, which have been informed by our decades of oligonucleotide synthesis manufacturing expertise, evolves IDT’s business model from Research Use Only to cGMP, and enables us to help more people.” Danaher Vice President and Group Executive Chris Riley added, “The future of genomic medicine hinges on the industrialization of biology to make life-saving therapies more accessible to people. As a pioneer in genome editing, IDT’s continued investments will enable customers to rapidly move from clinical development to commercialization. This new facility is another significant milestone in IDT’s innovation journey, one we envision will have a profound impact in genomic medicine for years to come.” The Therapeutic Oligo Manufacturing facility features ISO 8 cleanrooms, purification suites, chemical distribution and storage rooms, quality control labs, analytical lab space for product testing, ancillary and office spaces and shell space for future expansion. Manufacturing is performed in accordance with ICH Q7 cGMP standards for consistent and reliable quality. The controlled-access building features environmental controls for temperature, humidity and air pressure throughout, supported by an environmental program and continuous monitoring system. The addition of this new facility expands IDT’s global manufacturing footprint and enables the company to provide a range of manufacturing capabilities, including Research Use Only (RUO), large scale RUO, Engineering Run and cGMP (ICH Q7). A Decade of CRISPR Innovation Since 2015, IDT has continued to accelerate the pace of genomics with its complete portfolio of Alt-R™ CRISPR genome editing solutions. Its portfolio includes several first-to-market research products as well as solutions to meet researchers’ complete workflow—from design to analysis—to enable greater quality, simplicity, and cost efficiency. Last year, IDT launched the Alt-R™ HDR Donor Blocks, an improved solution for increasing homology-directed repair (HDR) rates in large fragment knock-in experiments, and expanded access to its Alt-R™ Custom CRISPR gRNA Libraries for drug discovery. In 2021, IDT also unveiled its rhAmpSeq™ CRISPR Analysis System, an end-to-end solution for characterizing and quantifying the full array of on- and off-target genome editing events in CRISPR research products. IDT’s research and development teams have also been at the forefront of CRISPR innovation, with achievements that include the development of multiple proprietary CRISPR reagents such as IDT’s Alt-R™ S.p. HiFi Cas9 Nuclease and the Alt-R L.b. and A.s. Cas12a (Cpf1) Ultra enzymes. Notably, their groundbreaking research and collaborations with scientists around the globe has been published in more than 200 scientific journals as peer-reviewed articles, and is helping to shape the future of genomics and biotechnology. IDT collaborated with M.A. Mortenson Company, a team led by OPN Architects and Barr Engineering Co. on the facility design and construction of its cGMP facility. About IDT For more than 35 years, Integrated DNA Technologies, Inc. (IDT) has been empowering genomics laboratories with an oligonucleotide manufacturing process unlike anyone else in the industry, with the most advanced synthesis, modification, purification, and quality control capabilities available. Since its founding in 1987, IDT has progressed from a leading oligo manufacturer to a genomics solutions provider supporting key application areas such as next generation sequencing, CRISPR genome editing, synthetic biology, digital PCR, and RNA interference. IDT manufactures products used by scientists researching many forms of cancer and most inherited and infectious diseases.

Read More

Medical

Zenfold Leverages Ginkgo Enzyme Services to Enable Veterinary Active Ingredient Development with Sustainable Biology

PR Newswire | October 17, 2023

Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, and Zenfold Sustainable Technologies, a company focused on developing and manufacturing specialty ingredients using sustainable technologies and precision fermentation, today announced a collaboration to leverage Ginkgo Enzyme Services in its effort to discover an enzyme critical to the manufacturing of veterinary products. This partnership aims to replace traditional chemical processes in veterinary active ingredient production with a sustainable biological method. "This collaboration marks a significant step forward in Zenfold's mission to bring sustainable manufacturing technology to the veterinary medicine industry," said Dr. BSV Prasad, CEO and Managing Director of Zenfold Sustainable Technologies. "By utilizing Ginkgo's expertise and innovation, we are well-positioned to develop a sustainable solution that will have a lasting impact on the Indian market and beyond." "We are excited to partner with Zenfold, which brings a powerful vision of sustainable biotechnology to veterinary active ingredient development. This collaboration will enable us to apply our state-of-the-art enzyme discovery module to enable more innovation in the veterinary medicine space," said Jennifer Wipf, SVP, Head of Commercial, Cell Engineering at Ginkgo. "The project involves creating a broad library of cDNA candidates from a metagenomic collection of billions of enzyme sequences. That's the kind of scale visionary projects like this need, and Ginkgo is committed to scaling up this solution for the betterment of animal health and the environment." About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. About Zenfold Zenfold Sustainable Technologies is a pioneer in the field of sustainable biology, with a focus on veterinary actives and enzyme supply. This collaboration with Ginkgo Bioworks marks Zenfold's expansion into the global veterinary market and further emphasizes their commitment to environmental responsibility and innovative biological solutions.

Read More

Medical

Flagship Pioneering Announces the Merger of Two Leading Programmable Medicine Platforms to Form Sail Biomedicines

PR Newswire | October 25, 2023

Flagship Pioneeringannounced the combination of Laronde and Senda Biosciences to launch Sail Biomedicines, a company pioneering the design and deployment of fully programmable medicines to transform patient care. Sail harnesses the power of first-in-category programmable payloads of Endless RNA™ (eRNA), first-in-category programmable nanoparticles, and emerging, proprietary AI technologies, to unlock the comprehensive programming of medicines for the first time. Guillaume Pfefer, Ph.D., MBA, who is also CEO-Partner at Flagship Pioneering, will become Sail's CEO and board member, while John Mendlein, Ph.D., who also serves as Executive Partner, Flagship Pioneering, will become the company's Executive Chairman. Sail unites Laronde and Senda Biosciences, two companies that deliver more than eight years of combined data and multi-product platform building. Senda's platform was the first to leverage a universal chemical code of natural nanoparticles that enables directed and repeatable deployment of payloads, such as translatable RNA, directly to cells and tissues of choice. Laronde pioneered eRNA, a new class of synthetic, translatable RNA that can be programmed to express diverse proteins inside the body, with vast therapeutic potential. "Endless RNA has the potential to create an entirely new class of programmable medicines across therapeutic areas that we will now be able to deliver directly to cells and tissues via deployment molecules with unique properties to confer specificity and greater tolerability," said Mendlein. "We believe these programmable medicines will be greatly enhanced via our proprietary generative AI technologies and rapid prototyping abilities to achieve breakthroughs currently beyond the grasp of the human mind. I look forward to working with the Sail Biomedicines team in this exciting new chapter." "Our deployment platform utilizes natural nanoparticles to shuttle biomolecules into human cells, with unique tropism, potency, and redosability," said Pfefer. "I look forward to leading the integration of these two teams to accelerate the development of new product candidates, build strategic partnerships, and enable diverse value pools, with the goal of swiftly delivering life-changing vaccines and therapies for the people who need them." "Sail Biomedicines builds on the progress made by two leading Flagship bioplatform companies and will enable integrative design for more effective programmable medicines," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering. "I am confident the combined leadership team and board will carry forward this company to realize its bold ambitions and ultimately deliver maximum impact for patients." In addition to Mendlein and Pfeffer, the Sail Biomedicines Board of Directors will comprise all current members of the Laronde and Senda Biosciences boards, as follows Pablo Cagnoni, M.D., President and Head of Research & Development, Incyte Jose "Pepe" Carmona, MBA, Chief Financial Officer, ADC Therapeutics Paula Hammond, Ph.D., Institute Professor, Massachusetts Institute of Technology, Head of Department of Chemical Engineering, Massachusetts Institute of Technology Avak Kahvejian, Ph.D., General Partner, Flagship Pioneering Ignacio Martinez, MBA, General Partner, Flagship Pioneering Sheri McCoy, M.S., MBA, Former Vice Chairman, Johnson & Johnson Mary Szela, MBA, CEO and President, TriSalus Life Sciences About Sail Biomedicines Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail's platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of generative AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering. About Flagship Pioneering Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. To date, Flagship has deployed over $3.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $26 billion of follow-on investments from other institutions.

Read More

Medical

Integrated DNA Technologies Opens New Therapeutic Manufacturing Facility to Support Growing Demand in Genomic Medicine

businesswire | October 19, 2023

Global genomics solutions provider Integrated DNA Technologies (IDT), an operating company in the Life Sciences segment of Danaher Corporation announced the completion of its new Therapeutic Oligonucleotide Manufacturing facility in Coralville, Iowa. The milestone marks a significant achievement in the company’s 35-year-history—its entrance into the therapeutics space—and enables IDT to manufacture products for research use through to current good manufacturing practice (cGMP) grade cell and gene therapy reagents to provide researchers with a single partner that can help them rapidly transition from the lab to therapeutic development. The 41,000-square-foot-site will produce cGMP cell and gene therapy reagents, including single guide RNAs (sgRNAs) and donor oligos for homology-directed repair (HDR) with additional offerings to follow. These new capabilities and offerings will be supported with comprehensive documentation and testing, a support team, and regulatory guidance to help accelerate researchers’ path to the clinic. “An increasing number of customers are seeking out IDT as a trusted partner for their CRISPR genome editing needs, and are asking us to be the provider that can help them bridge the gap from lab to clinic,” said Demaris Mills, president, IDT. “Now, with our new cGMP manufacturing facility, IDT can provide a complete CRISPR workflow—from design to analysis—that supports cell and gene therapy developers in all stages of therapeutic development, with the same support and expertise they have come to know from IDT. These new manufacturing capabilities, which have been informed by our decades of oligonucleotide synthesis manufacturing expertise, evolves IDT’s business model from Research Use Only to cGMP, and enables us to help more people.” Danaher Vice President and Group Executive Chris Riley added, “The future of genomic medicine hinges on the industrialization of biology to make life-saving therapies more accessible to people. As a pioneer in genome editing, IDT’s continued investments will enable customers to rapidly move from clinical development to commercialization. This new facility is another significant milestone in IDT’s innovation journey, one we envision will have a profound impact in genomic medicine for years to come.” The Therapeutic Oligo Manufacturing facility features ISO 8 cleanrooms, purification suites, chemical distribution and storage rooms, quality control labs, analytical lab space for product testing, ancillary and office spaces and shell space for future expansion. Manufacturing is performed in accordance with ICH Q7 cGMP standards for consistent and reliable quality. The controlled-access building features environmental controls for temperature, humidity and air pressure throughout, supported by an environmental program and continuous monitoring system. The addition of this new facility expands IDT’s global manufacturing footprint and enables the company to provide a range of manufacturing capabilities, including Research Use Only (RUO), large scale RUO, Engineering Run and cGMP (ICH Q7). A Decade of CRISPR Innovation Since 2015, IDT has continued to accelerate the pace of genomics with its complete portfolio of Alt-R™ CRISPR genome editing solutions. Its portfolio includes several first-to-market research products as well as solutions to meet researchers’ complete workflow—from design to analysis—to enable greater quality, simplicity, and cost efficiency. Last year, IDT launched the Alt-R™ HDR Donor Blocks, an improved solution for increasing homology-directed repair (HDR) rates in large fragment knock-in experiments, and expanded access to its Alt-R™ Custom CRISPR gRNA Libraries for drug discovery. In 2021, IDT also unveiled its rhAmpSeq™ CRISPR Analysis System, an end-to-end solution for characterizing and quantifying the full array of on- and off-target genome editing events in CRISPR research products. IDT’s research and development teams have also been at the forefront of CRISPR innovation, with achievements that include the development of multiple proprietary CRISPR reagents such as IDT’s Alt-R™ S.p. HiFi Cas9 Nuclease and the Alt-R L.b. and A.s. Cas12a (Cpf1) Ultra enzymes. Notably, their groundbreaking research and collaborations with scientists around the globe has been published in more than 200 scientific journals as peer-reviewed articles, and is helping to shape the future of genomics and biotechnology. IDT collaborated with M.A. Mortenson Company, a team led by OPN Architects and Barr Engineering Co. on the facility design and construction of its cGMP facility. About IDT For more than 35 years, Integrated DNA Technologies, Inc. (IDT) has been empowering genomics laboratories with an oligonucleotide manufacturing process unlike anyone else in the industry, with the most advanced synthesis, modification, purification, and quality control capabilities available. Since its founding in 1987, IDT has progressed from a leading oligo manufacturer to a genomics solutions provider supporting key application areas such as next generation sequencing, CRISPR genome editing, synthetic biology, digital PCR, and RNA interference. IDT manufactures products used by scientists researching many forms of cancer and most inherited and infectious diseases.

Read More

Medical

Zenfold Leverages Ginkgo Enzyme Services to Enable Veterinary Active Ingredient Development with Sustainable Biology

PR Newswire | October 17, 2023

Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, and Zenfold Sustainable Technologies, a company focused on developing and manufacturing specialty ingredients using sustainable technologies and precision fermentation, today announced a collaboration to leverage Ginkgo Enzyme Services in its effort to discover an enzyme critical to the manufacturing of veterinary products. This partnership aims to replace traditional chemical processes in veterinary active ingredient production with a sustainable biological method. "This collaboration marks a significant step forward in Zenfold's mission to bring sustainable manufacturing technology to the veterinary medicine industry," said Dr. BSV Prasad, CEO and Managing Director of Zenfold Sustainable Technologies. "By utilizing Ginkgo's expertise and innovation, we are well-positioned to develop a sustainable solution that will have a lasting impact on the Indian market and beyond." "We are excited to partner with Zenfold, which brings a powerful vision of sustainable biotechnology to veterinary active ingredient development. This collaboration will enable us to apply our state-of-the-art enzyme discovery module to enable more innovation in the veterinary medicine space," said Jennifer Wipf, SVP, Head of Commercial, Cell Engineering at Ginkgo. "The project involves creating a broad library of cDNA candidates from a metagenomic collection of billions of enzyme sequences. That's the kind of scale visionary projects like this need, and Ginkgo is committed to scaling up this solution for the betterment of animal health and the environment." About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. About Zenfold Zenfold Sustainable Technologies is a pioneer in the field of sustainable biology, with a focus on veterinary actives and enzyme supply. This collaboration with Ginkgo Bioworks marks Zenfold's expansion into the global veterinary market and further emphasizes their commitment to environmental responsibility and innovative biological solutions.

Read More

Events