CRISPR Flies Take Leaf Out of Butterfly Book to Exploit Predator-Deterring Toxins

GEN | October 03, 2019

An international team of researchers headed by scientists at the University of California (UC), Berkeley, has used CRISPR-Cas9 genome editing to turn fruit flies that might otherwise represent a handy snack for frogs and birds, into potentially poisonous prey that could cause anything that eats them—including humans—to vomit. The team, led by Noah K. Whiteman, PhD, principal investigator and an associate professor at UC Berkeley, introduced into the flies the same three mutations in a single gene that are carried by the monarch butterfly (Danaus plexippus), which can eat and sequester the poisonous plant milkweed as caterpillars, and then retain some of the toxin as adult butterflies, to deter predators. Milkweed is a highly toxic plant that would kill most animals, including humans. But like the monarch butterfly, the CRISPR-engineered fruit fly larvae were similarly able to eat milkweed and retain the plant’s toxins when they metamorphosed into now-poisonous adult “Monarch flies”. Critically, the mutations had to occur in the right sequence, otherwise the flies would not have survived the three separate mutational events.

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INDUSTRY OUTLOOK

Andelyn Biosciences Selects TetraScience as a Strategic Partner for Innovation in Therapeutics Development and Manufacturing

Andelyn Biosciences | August 26, 2021

TetraScience, the R&D Data Cloud company, announced today that Andelyn Biosciences, Inc. has selected the Tetra Data Platform (TDP) to build a cloud-native development and manufacturing service for its customers. As part of an Andelyn Biosciences initiative to create a Connected Plant that harmonizes data from building and facilities, process and manufacturing, and lab instrument sources, TDP will enable better compliance, easier analysis, faster decisions, and more agile operations. Additionally, Andelyn customers will benefit from secure, convenient access to harmonized data that is prepared for analytics and visualization. As a Contract Development and Manufacturing Organization (CDMO) for cell and gene therapies, Andelyn must remain GMP-compliant and increase efficiency while leading the industry in the innovative services they provide to customers. By launching a Connected Plant, Andelyn will gain autonomous operation, predictive capabilities, improved process monitoring and control, and increased data integrity. "Andelyn has been a pioneer in gene therapy with a 15-year history accelerating the development and manufacturing of innovative therapies to bring more treatments to more patients," said Bryan J. Holmes, Vice President, Information Technology at Andelyn Biosciences. "Together with TetraScience, we're transforming how we work with our clients, utilizing fully-digitized, cloud-native services to help connect all the plant and lab data created during complex development and manufacturing cycles." Andelyn chose TDP for its unique ability to harmonize data from building & facilities systems, lab instruments, and process & manufacturing equipment. By replatforming the data to a future-proof managed cloud environment, Andelyn will benefit from enhanced GMP compliance and data integrity, improved time-to-value, and lower TCO. Additionally, with an open data cloud platform powered by TDP and the Tetra Partner Network, Andelyn will be able to leverage their preferred tooling for analytics while supporting their customers' data consumption needs. "We're excited to partner with Andelyn Biosciences on their mission-critical data cloud initiative and accelerate their journey towards becoming a digital company," stated Chad Garrett, TetraScience CRO. "As an innovator in providing cloud-native development and manufacturing services to its customers, Andelyn Biosciences recognizes that harmonizing scientific data in the cloud and making it easily accessible to clients will transform the way CDMOs exchange data with clients." Andelyn's initial deployment of TDP is focused on acquiring and harmonizing historical data across key sources while enabling enhanced data search capabilities. Moving forward, Andelyn expects to complete the rollout of the Connected Plant with additional data sources and instruments, and ultimately launch a groundbreaking digital CDMO experience for their customers. About Andelyn Biosciences, Inc. Andelyn Biosciences is a pioneering gene therapy company born out of Nationwide Children's Hospital, where the first FDA-approved systemic gene therapy was discovered. Andelyn is named in honor of two gene therapy pioneers who participated in pivotal Phase I clinical trials at Nationwide Children's Hospital 8-year-old Andrew and 8-week-old Evelyn. Bringing together more than 15 years of experience in AAV vector manufacturing, Andelyn is a full-spectrum Contract Development Manufacturing Organization (CDMO) that helps pioneer solutions that turn hope into reality. Our mission is to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We accomplish this by bringing scalability, capacity, efficiency and expert resources to manufacturing matrices, all to advance the development of viral vector-based therapeutics. Our capabilities include viral vector process and analytical development, small to large scale GMP manufacturing, fill/finish and QC/QA release testing through Phase III with plans to launch commercial services in 2022. Andelyn also offers plasmid manufacturing services, formulation development services and regulatory support.

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AI

WhiteLab Genomics and the Accelerator for Technological Research in Genomic Therapies Collaborate on AI for Gene Therapy Bioproduction

WhiteLab Genomics | June 01, 2021

As part of this collaboration, teams from the Accelerator for Technological Research in Genomic Therapies (ART-TG, Inserm US35) and WhiteLab Genomics will use the WhiteLab Genomics CatalystTM platform to generate a database specific to the bioproduction of lentiviral vectors, which will be used to identify the parameters allowing for a significant increase in vector quality as well as their production yields, and to reduce the production costs. Cell and gene therapy is a new biomedical approach that can treat a growing number of genetic and acquired diseases such as cancer. To keep up with their growth, the pharmaceutical manufacturing of these Advanced Medicinal Therapies needs to accelerate in terms of standardization and process control. Because purifying lentiviral vectors remains complex and at critical capacity, the partnership is focused on manufacturing lentiviral vectors, which are used in many gene therapies approaches, including the manufacture of CAR-T cells. The teams will utilize AI to analyze information from multiple sources to optimize existing processes and develop new ones. The approach used with the lentiviral vectors will apply to various bioproducts. This initiative is made possible due to funding from the Ile de France Region, which supports bioproduction efforts as part of its Ile-de-France Leader Bioproduction scheme, which was launched at the end of 2020. About ART-TG RT-TG is an Inserm innovation center located in Génopole d'Evry with the mission of promoting research excellence in gene and cell therapy by facilitating the transfer of therapeutic discoveries to clinical or industrial applications. ART-TG is a pre-industrial laboratory for testing technological innovation and pharmaceutical product and process development. ART-TG is now leading several innovative projects based on lentiviral vectors, or CRISPR genome editing tools for ex vivo uses, focusing on immunotherapy and hematology. ART-TG is a subsidiary of the industrial integrator MAGENTA (MAnufacturing Cell and GEN Therapy Advances) of the French Government Biomedicines Challenge. About WhiteLab Genomics WhiteLab Genomics, founded in 2019 by David Del Bourgo, Julien Cottineau, and Lucia Cinque, is a French start-up specialized in artificial intelligence solutions for biotherapies such as gene and cell therapies. Its proprietary technology enables multi-parametric analysis of complex biological data to optimize and reduce treatment development costs. WhiteLab Genomics makes this one-of-a-kind technology available to its clients through the Catalyst platform, which is available in SaaS mode. The start-up is presently based in Genopole - Evry, France's first biocluster, and Station F.

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CELL AND GENE THERAPY

PerkinElmer Completes Acquisition of Antibody and Reagent Leader BioLegend

PerkinElmer | September 18, 2021

PerkinElmer, Inc.a global leader committed to innovating for a healthier world, today announced it has completed its acquisition of BioLegend, a leading, worldwide provider of life science antibodies and reagents for a total consideration of approximately $5.25 billion. The acquisition, the largest in PerkinElmer’s history, further expands the Company’s life science franchise into high-growth areas such as cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation and bioprocessing. BioLegend’s stellar leaders, teams and technologies will play a critical role in our combined companies’ ability to provide new, innovative solutions to scientists -- helping drive novel therapeutic discovery and development. We also look forward to BioLegend significantly enhancing our leading reagents portfolio as we partner together to innovate and advance science for our customers. - Prahlad Singh, president and chief executive officer of PerkinElmer We are very excited to roll up our sleeves and work together with our new PerkinElmer colleagues to mutually leverage our portfolios, people and shared passion for innovation and science to accelerate the discovery and development of novel therapeutics. PerkinElmer’s broad life science platform and strong global infrastructure will help BioLegend continue to extend our mission of enabling our customers to do legendary discovery. - Gene Lay, founder, president and chief executive officer of BioLegend As previously communicated, it is expected that BioLegend will contribute an incremental $380 million of revenue and $0.30 of adjusted earnings per share accretion to PerkinElmer in fiscal year 2022. Additional commentary regarding its expected financial contribution to the remainder of the current fiscal year will be provided on the Company’s upcoming third quarter 2021 earnings call. PerkinElmer’s expectations for incremental adjusted earnings per share accretion for fiscal year 2022 attributable to BioLegend is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measure without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items PerkinElmer excludes from this non-GAAP measure. The timing and amounts of such events and items could be material to PerkinElmer’s results prepared in accordance with GAAP. About PerkinElmer PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life science, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 15,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index.

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