CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Azenta Life Sciences | February 28, 2023
On February 27, 2023, Azenta Life Sciences, a leading provider of life sciences solutions, announced the launch of its latest automated cryogenic storage system, the Cryo Store PicoTM. This new product is designed to store high-value biological samples used throughout various stages of the life sciences industry, from research and development to clinical use.
Azenta is already known for providing innovative automated cryogenic solutions such as the BioStore™ III Cryo and the CryoPod™ Carrier, and the Pico is the latest addition to its lineup. The product offers automated cryogenic solutions that are configured for laboratory and clinical procedures.
The Pico offers a variety of features for cell and gene therapy developers and manufacturers, including end-stage deployment in hospitals and clinics. It offers controlled access and traceability to support regulatory compliance with a compact footprint and is also user-friendly for laboratory personnel.
Interested parties can order the Pico now, and a live demonstration will take place at the Society for Laboratory Automation and Screening (SLAS) 2023 International Conference in San Diego, California.
Pico's Product Manager Erica Waller commented, "Pico takes our proven automation capabilities and scales it down for the lab or the clinic, bringing the sample integrity and process rigor of automation closer to the point of use,"
(Source – PR Newswire)
About Azenta Life Sciences
Azenta is a leading life sciences solutions provider that helps to accelerate the development and delivery of impactful therapies to market. The company offers a comprehensive suite of cold-chain sample management solutions and genomic services for areas such as clinical research, drug development and advanced cell therapies. These solutions are trusted by some of the top biotech, pharmaceutical, academic, and healthcare institutions worldwide. Headquartered in Chelmsford, MA, Azenta has a global presence with operations across Europe, North America, and Asia. The company is committed to providing reliable, innovative, and high-quality solutions to meet the needs of its clients in the life sciences industry.
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INDUSTRIAL IMPACT, DIAGNOSTICS
Globenewswire | April 10, 2023
Avid Bioservices, Inc. a dedicated biologics contract development and manufacturing organization working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, announced the completion of two expansions within the company’s mammalian cell facilities. The company expects that the first customer for the newly expanded CGMP mammalian cell suites will begin manufacture this month. To celebrate the launch of the newly expanded facilities, Avid is hosting an open house and tour for existing and prospective clients.
“We are proud to unveil our completed expansions and excited to kick off the first customer project within our latest, state-of-the-art mammalian cell manufacturing suites. These build-outs involved great complexity and required exemplary efforts from our entire team. I would like to acknowledge the tremendous work from everyone who played a role in completing these significant projects on schedule,” said Nick Green, president and chief executive officer of Avid Bioservices. “This launch could not be timed any better based on the significant demand we continue to see for our mammalian cell services, highlighted by significant new business wins and the largest backlog in the history of the company.”
The newly expanded manufacturing capacity includes both upstream and downstream CGMP manufacturing suites and serves as complement to Avid’s existing Myford facility, providing increased capacity to address the needs of both existing and future mammalian cell business customers. The addition of the capacity provided by the new manufacturing suites within the Myford facility has the potential to generate approximately an additional $100 million in annual revenue.
In addition to the launch of the newly expanded Myford facility, Avid also announced the completion of its mammalian cell process development expansion, which has doubled the company’s total process development capacity. Now operational, these new capabilities have the potential to support up to an additional $25 million in annual process development revenue.
With the completion of these mammalian cell capacity expansion projects, Avid’s sole ongoing expansion effort involves the build-out of its new cell and gene therapy facility which will support early-stage development through commercial manufacturing. The company has already launched analytical and process development capabilities at this viral vector facility and remains on track to launch the CGMP manufacturing suites by the end of the third quarter of calendar 2023.
Upon completion of the CGT Facility, we estimate that our combined facilities will have the potential to bring our total revenue generating capacity to up to approximately $400 million annually.
About Avid Bioservices, Inc.
Avid Bioservices an S&P SmallCap 600 company, is a dedicated contract development and manufacturing organization focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 30 years of experience producing monoclonal antibodies and recombinant proteins, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization.
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INDUSTRY OUTLOOK
Globenewswire | May 04, 2023
Magenta Therapeutics, Inc. and Dianthus Therapeutics, Inc. a privately-held, clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, announced today that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on advancing Dianthus’ pipeline of next-generation complement inhibitors, including DNTH103 currently in a Phase 1 clinical trial. Upon completion of the merger, the combined company is expected to operate under the name Dianthus Therapeutics, Inc. and trade on the Nasdaq under the ticker symbol “DNTH”.
In support of the merger, Dianthus has secured commitments for a $70 million private investment in its common stock and pre-funded warrants from a syndicate of healthcare investors led by Fidelity Management & Research Company, Catalio Capital Management, 5AM Ventures, Avidity Partners, Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures and Venrock Healthcare Capital Partners, that is expected to close immediately prior to completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have approximately $180 million of cash or cash equivalents immediately post-closing. The cash resources are intended to be used to advance Dianthus’ pipeline through multiple clinical data catalysts and is expected to fund operations into mid-2026. The merger and related financing are expected to close in the third quarter of 2023.
“I’m delighted to announce this planned merger with Magenta, which comes at a pivotal moment in the evolution of our company as we advance our pipeline of next-generation complement therapeutics for people living with severe autoimmune diseases,” said Marino Garcia, President and Chief Executive Officer of Dianthus Therapeutics. “Gaining access to the public capital markets can enhance our financial strength and fuel our growth strategy, enabling us to unlock the full potential of our pipeline, including our plans to address multiple autoimmune disorders with our clinical-stage active C1s inhibitor, DNTH103.”
“After a thorough exploration of our strategic alternatives, management and our Board of Directors believe the transaction with Dianthus Therapeutics will culminate in a successful outcome for our stockholders,” said Steve Mahoney, President, Chief Financial and Operating Officer of Magenta. “Dianthus has made rapid progress in developing and advancing DNTH103 into the clinic where it has the potential to be a transformative classical pathway inhibitor for severe autoimmune diseases. We are extremely grateful to our current and former employees who contributed to Magenta’s efforts to develop its programs and we now look forward to the combined company’s advancement on opportunities for value creation for patients.”
Magenta previously announced a comprehensive review of strategic alternatives in February 2023 and has since completed winding down a majority of its activities and costs associated with its research and development initiatives, including the termination of its lease and the sale of key assets.
erving as co-financial adviser and Goodwin Procter LLP is serving as legal counsel to Magenta Therapeutics. Jefferies, Evercore ISI, Guggenheim Securities and Raymond James are serving as the placement agents to Dianthus Therapeutics, and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Dianthus Therapeutics.
About Magenta Therapeutics
Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.
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