Nucleus Biologics Unveils World's First Online Portal for Instantaneous Custom cGMP Cell Culture Media Configuration

Nucleus Biologics, a leader in precision cell culture, today announced the availability of NB-Lux™, an online configuration and ordering platform for cell culture media. Designed for developers of cell therapies, NB-Lux™ speeds formulation development by providing real time pricing for cGMP grade media in lot sizes from two liters to 2000 liters. Media is a critical component in the production of cell therapies. During development, companies iteratively test multiple formulations to identify an optimal medium for cGMP manufacturing. Some therapy developers utilize proprietary, off-the-shelf formulations for perceived streamlining in regulatory processes. However, unknown formulations are difficult to tailor to specific therapies, are not part of a therapy company's intellectual property portfolio and are vulnerable to supply chain issues due to sole sourcing. Equally undesirable, custom media currently takes up to six months to manufacture after it has been formulated. "Our mission is to speed the time from discovery to cure. We listened to the frustration of our cell therapy customers and reimagined the cell culture media configuration and ordering experience. No longer must a scientist guess what to add to proprietary, sole sourced medias or wait almost half a year to receive custom media," said David Sheehan, Founder, President and CEO of Nucleus Biologics. "NB-Lux™, a first-of-its-kind portal, empowers a scientist to create their own formulas, get real time quotes, and, in some situations, have cGMP media manufactured in as little as 9 weeks. This is the first step in our plan to reshape the media market. My sense is the COVID-19 pandemic has punctuated the need for the scientific community and industry to create new paradigms that expedite delivery of proven therapies." Nucleus Biologics developed the patent-pending NB-Lux™ to provide real time quotes for cGMP cell culture media. Users can input and manipulate different formulations online, receive real time pricing, and track order progress. NB-Lux™ is powered by one of the largest repositories of over 400 publicly available formulations. Users can optimize each individual chemical component, testing requirements, and packaging. By customizing a media to the unique critical attributes of each therapy, developers can take control of formulations, rapidly progress from small- to large-scale production, and move therapies to the clinic faster.

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Stevanato Group Launches EZ-fill® Kit and Laboratory Fill and Finish Service to Support Small Batch Drug Development and Commercialization

Stevanato Group | January 25, 2024

Stevanato Group S.p.A. a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, unveiled today two new offerings for efficient small batch pharmaceutical manufacturing: the EZ-fill® Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers (TEC). In a context where reducing time-to-market is key, Stevanato Group’s new EZ-fill® Kit offers fast access to a customizable and versatile solution to pharma and biotech companies needing to efficiently fill small batches with high-quality injectable formulations during clinical trials or commercial phases. The surge the industry has seen in biopharmaceuticals treating various diseases in several therapeutical areas may signal a significant growth potential for pharmaceutical companies. Injectables, comprising more than 60% of the over 21,000 drugs currently in development, of which 44% are biopharmaceuticals, require high-performance primary packaging and delivery technologies for proper storage and administration. Stevanato Group’s EZ-fill® Kit builds on its existing ready-to-use platform of pre-sterilized containment solutions – vials, cartridges, and syringes – allowing customers to effectively screen different primary packaging in combination with drug products. The kit will be available as a modular box made up of glass ready-to-use drug containers and add-on components on request, shipped by courier. As a result, the platform can bring enhanced levels of quality and safety to patients across the entire drug life cycle and improve the rate at which new drugs enter the market. EZ-fill® Kit will be presented at Pharmapack and is expected to be available commercially beginning in the second quarter of 2024. Additionally, to better support customers, Stevanato Group has introduced a non-GMP laboratory filling and finishing service at its Technology Excellence Centers (TEC) in Boston, USA, and Piombino Dese, Italy. This new service allows customers to assess and identify the possible effects of the fill-and-finish process on their product performance as early as the container selection stage, thus de-risking processes and enhancing development and commercialization strategy. “In the race to bring new advanced biopharmaceutical products to market and to patients, Stevanato Group is tackling the challenge of supporting customers with flexible drug containment and filling solutions in a timely manner," says Fabio Bertacchini, Senior Director EZ-fill® Vials & Cartridges at Stevanato Group. "Stevanato Group remains focused on developing new offerings that can help raise pharmaceutical manufacturing standards. By leveraging the expertise provided by our global TEC Centers, we aim to support customers' innovation, helping them face tests and de-risking processes and making right-the-first-time choices throughout their drug development journey.” About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.

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CCM Biosciences Announces Launch of 5Prime Sciences Business Unit

CCM Biosciences | January 01, 2024

Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology. 5Prime’s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics. 5Prime has two focus areas: 1) in vitro diagnostic (IVD) tests: a wide array of companion diagnostics (CDx) tests for targeted cancer, rare disease, and prenatal/preimplantation diagnostics, developed using the droplet digital Polymerase Chain Reaction (ddPCR) and Next-Generation Sequencing (NGS) methodologies, which accompany the personalized medicine therapeutic (Rx) pipeline of CCM Bio; 2) synthetic biology: engineered DNA- and RNA-manipulating enzymes that improve upon the enzymes used in IVD tests, in PCR reagents, and also in enzymatic DNA/RNA synthesis. Proven technology behind market-leading DNA sequencing products and diagnostic tests; including one of the 5 highest revenue-generating technologies invented in the history of Princeton University Focus areas 1 and 2 are based on the company’s patented technology originating in the PhD thesis work of Co-Founder and CEO Dr. Raj Chakrabarti at Princeton University. According to the Princeton University Office of Technology Licensing, patents in this portfolio, which are now controlled by 5Prime, are among the top 5 revenue-generating patents in the history of the university, having been commercialized in collaboration with companies such as Celera Diagnostics, Quest Diagnostics, Abbott, New England Biolabs, and Toyobo Life Sciences. Diagnostic tests and products based on the company’s intellectual property include the XSense test from Quest Diagnostics, which is the leading DNA-based carrier screening test for autism (Fragile X syndrome); and the Q5 polymerase kit marketed by New England Biolabs, which is the leading high-fidelity polymerase kit for DNA sequencing. In the context of molecular diagnostics, NGS is typically applied to diagnose in high-throughput the patterns of DNA mutations in genes. A related method called RNA-Seq, which applies NGS to RNA rather than DNA to measure real-time gene expression levels, has emerged as a foundation for modern personalized medicine. However, a notorious difficulty in both traditional NGS and RNA-Seq is sequence bias, which results in inaccurate estimates of the relative copy numbers of different genes and associated disease-causing mutations, and which has limited the transformative potential of these methods. ddPCR is a sensitive method for diagnosing mutations in specific disease-associated genes that is also limited by problems of sequence bias. 5Prime’s technology enables the efficient polymerization and amplification of nearly any DNA or RNA sequence to overcome sequence bias in nucleic acid amplification and associated diagnostic methods like NGS and ddPCR, the global markets for which were valued at $10B and $6B, respectively, in 2022 and expected to surpass $44B and $14B, respectively, by 2032. Its state-of-the-art synthetic biology platform for polymerase enzyme engineering generates proprietary polymerases with optimal properties for NGS or PCR-based diagnostic tests, by applying machine learning algorithms to the big data generated from ultrahigh-throughput, microfluidic experimental screening of enzyme activity. In addition, the company’s technology platform applies proprietary nonaqueous media and computational systems biology methods in conjunction with such enzymes to dramatically improve nucleic acid polymerization and amplification efficiency. About CCM Biosciences CCM Biosciences, Inc. is a biotechnology company dedicated to discovering and developing novel drugs - including small molecules, gene therapies, biologics, and nanomedicines - as well as associated companion diagnostics. CCM Bio’s patented molecular discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, American Chemical Society journals and Nature Publishing Group journals. CCM Bio is partnered with the global chemical and pharmaceutical services company PMC Group, Inc. for fully integrated discovery, development and manufacturing of drugs and diagnostics.

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Andelyn Biosciences and Armatus Bio Partner to Manufacture Suspension-Based AAV Gene Therapy for Rare Neurological Disease

Andelyn Biosciences, Inc. | January 16, 2024

Andelyn Biosciences, Inc., a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has partnered with Armatus Bio to accelerate manufacturing of their gene therapy treatment for Charcot-Marie-Tooth Type 1A (CMT1A), a rare genetic neurological disease associated with independence-limiting disability and risk of fatal complications that has no approved therapies today. The partnership will seek to maximize program efficiency and speed to clinical studies of this novel, precision approach. As part of the agreement, Armatus will leverage Andelyn's extensive experience in adeno-associated virus (AAV) production and its proprietary suspension platform for development activities, plasmid manufacturing, and viral vector toxicology and GMP clinical manufacturing. The partnership strengthens the working relationship and offers great hope for patients suffering from neuromuscular disease. Both organizations, located in the well-established and growing biotech hub of Columbus, Ohio, are aligned in their belief that the rise of gene therapies will continue to advance human health. Matt Niloff, Chief Commercial Officer at Andelyn Biosciences said, "We are extremely moved by Armatus Bio's commitment to address the urgent unmet needs in CMT1A and are impressed by its innovative therapeutic technology for the disease. We look forward to scaling up the process in our program-specific, configurable suspension platform, and accelerating the therapy into the clinic with the highest degree of quality." "Andelyn has demonstrated its strong capabilities in manufacturing complex genetic medicines with high quality and consistency, which will be critical to accelerating our development efforts," said Brian Price, PhD, Chief Technical Officer of Armatus. "We look forward to collaborating with Andelyn on this program as we work toward supporting this population that urgently awaits innovative solutions." From its time-tested experience, Andelyn is proud to offer its clients exceptional development, plasmid production, and quality manufacturing at its three Columbus, Ohio facilities. Andelyn is advancing client discoveries and manufacturing life-altering cell and gene therapies for rare and prevalent diseases. About Andelyn Biosciences, Inc. Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn's deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of three Columbus, Ohio facilities, Andelyn supports its clients in developing curative cell and gene therapies from concept through plasmid development and manufacturing, process development, and cGMP clinical and commercial manufacturing. Andelyn's versatile capabilities include cGMP manufacturing capacity for both adherent and suspension processes up to a 2,000-liter capacity. An advanced digital model, quality system, full regulatory support and supply chain vertical integration help Andelyn accelerate the development and manufacturing of its clients' innovative cell and gene therapies. About Armatus Bio Armatus Bio is a privately held late preclinical stage biotechnology innovator leveraging vectorized RNAi to address urgent unmet medical needs in genetically-driven neurological diseases. Based in Columbus, Ohio, the company is led by a seasoned team with expertise in drug development and delivery, and partnered with world renowned experts in vector biology, genomics, and neurology. The company's lead candidate for Charcot Marie Tooth Type 1A (CMT1A) has received Orphan Drug Designation and Rare Pediatric Drug Designation, and is advancing toward IND-enabling studies. The company is also developing a preclinical vectorized RNAi asset for the rare neuromuscular disease Facioscapulohumeral Muscular Dystrophy (FSHD).

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Frontage Laboratories Acquires Accelera S.r.l.'s Bioanalytical and DMPK Businesses

Frontage | January 02, 2024

Frontage Laboratories, Inc. announced that, through its wholly-owned subsidiary Frontage Europe S.r.l., it has completed the acquisition of the Bioanalytical and Drug Metabolism & Pharmacokinetics businesses of Accelera S.r.l (Accelera). Accelera is a premier Contract Research Organization located in Nerviano, within the Lombardy region of Italy, part of the well-established NMS Group S.p.A. which has positioned itself as a global niche player in delivering discovery & preclinical studies and clinical bioanalysis to pharma and biotechnology companies, academic institutions, and other healthcare stakeholders. "Today marks a very significant achievement in the 23-year history of Frontage Laboratories, as we establish a base of operations in continental Europe. Accelera has developed a tremendous reputation for high quality R&D services and we look forward to welcoming their Bioanalytical and Drug Metabolism & Pharmacokinetics teams to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "We envision this strategic acquisition as a first step in establishing Frontage's footprint in Europe, with the intent of adding other service areas in the continent. We believe both existing Frontage and Accelera clients stand to benefit greatly by leveraging Frontage's increasingly global platform. In addition, we are looking forward to partnering with the remaining Accelera business on exciting opportunities to service clients across our organizations." According to Dr. Song Li, Founder and Chairman of Frontage: "It has been a long-standing goal of Frontage to expand our operations in Europe. We consider ourselves fortunate to capitalize on our outstanding relationship with the Accelera team, which has enabled us to bring our plans to fruition. We are very enthusiastic about working together as we further develop the Frontage platform in Europe, starting from a footprint in the Biopark in Nerviano Lombardy, where Accelera and Nerviano Medical Sciences Srl have already established a long-standing and efficient value chain. As always, our ongoing focus will remain on delivering the highest levels of quality, technology and expertise to our clients." "We are thrilled to join forces with Frontage as part of this strategic acquisition that marks a significant milestone in Accelera's journey," said Luca Leone, CEO of Accelera. "Accelera has built a strong reputation for delivering high-quality R&D services through all phases of drug research and development with extensive experience in oncology. This unique occasion opens up new horizons for collaboration and growth. On one hand, we will further focus on offering top-notch In-vivo (end-to-end services) for multiple emerging modalities. At the same time, we look forward to exploring exciting opportunities to serve our clients across continents through our ongoing collaboration. This partnership reflects our commitment to advancing research and providing innovative solutions in the European market and beyond," said Luca Leone, CEO of Accelera S.r.l. "Having Frontage as part of the growing partners operating from our Biopark is a landmark moment for us. In addition to the endless potential of the Accelera-Frontage collaboration, Nerviano Medical Sciences can leverage Frontage's world-class capabilities to drive breakthrough advancements in our drug discovery and development process. By uniting our strengths, we believe we can accelerate the pace of innovation and make a lasting difference in the field where all companies of this strong alliance operate and thrive here in Nerviano," said Hugues Dolgos, CEO of NMS Group S.p.A and Nerviano Medical Sciences Srl.V About Frontage Frontage Holdings Corp together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.

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