AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that provides extensive services for the cell and gene therapy sector. With a global network of facilities in the US, Europe, and Asia, the company offers a comprehensive suite of services spanning from initial development to clinical and commercial manufacturing. Their expertise covers various therapeutic modalities, specializing in cell culture and modification. AGC Biologics is distinguished by its ability to develop and manufacture diverse cell therapies using numerous technologies, including both closed and open systems at different scales to meet specific client needs. They provide flexible and cost-effective solutions for process development and pre-clinical requirements, backed by quality systems and regulatory experience to support critical product milestones.
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Lonza
Lonza is a global leader in cell and gene therapy manufacturing, renowned for its extensive experience in providing both clinical and commercial production services. Operating as a major CDMO, Lonza offers comprehensive solutions vital for therapeutic developers, including specialized process development, complex personalized medicine production, and essential regulatory support. The company’s strategic focus and significant investment have resulted in state-of-the-art facilities that are specifically equipped to handle the complexities and scale required for commercial cell therapy manufacturing. Lonza’s capabilities enable them to meet the rigorous global demands of the industry, positioning them as a critical, preferred partner for biotechnology companies seeking to efficiently scale their cell therapy operations and successfully bring their innovative products to market worldwide.
Charles River Laboratories
Charles River Laboratories is a major pharmaceutical firm that provides essential products and services across the life sciences industry, with a substantial and growing commitment to cell therapy manufacturing services. This focus was significantly bolstered by the strategic acquisition of Cognate Bioservices in 2021. Through this integration, Charles River expanded its offering to provide a comprehensive, end-to-end suite of services to pharmaceutical, biotechnology, and academic organizations. Their robust portfolio now spans preclinical services and specialized manufacturing support for cell and gene therapy, facilitating the efficient advancement of novel therapies. By offering integrated solutions from early-stage research through development and manufacturing, Charles River Laboratories supports global clients in translating scientific discoveries into clinical and commercial cell therapy products.
Catalent
Catalent is a key player and a significant CDMO in the cell therapy manufacturing space, leveraging its robust capabilities initially established within the broader biologics sector. The company has made substantial strides by investing in advanced technologies and maintaining a strong focus on innovation specific to cell and gene therapies. Catalent’s manufacturing services are designed to partner with biotech companies, providing the necessary expertise and compliant infrastructure to bring their complex cell therapies through development and into the commercial market. The firm is recognized for its commitment to quality and for offering a reliable pathway that helps streamline and de-risk the intricate processes involved in advanced therapeutic manufacturing.
Thermo Fisher Scientific
Thermo Fisher Scientific has emerged as a noteworthy CDMO in the cell therapy market, having significantly strengthened its capabilities through strategic acquisitions and continuous investment. The company provides an integrated suite of services that encompasses the entire cell therapy development lifecycle, from foundational early-stage research and process optimization to full-scale commercial production and distribution. Thermo Fisher is well-equipped to support the intricate requirements of cell therapy manufacturing, leveraging its extensive scientific solutions portfolio and emphasizing stringent quality control and compliance. By integrating microfluidic technology and other high-throughput systems into its offerings, the company acts as a crucial global provider, accelerating development, diagnostics, and fundamental biological research for its partners.
Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult is a leading, independent center in the UK dedicated to advancing the commercialization and uptake of cell and gene therapies. Established in 2012, its primary service involves providing essential infrastructure, deep expertise, and collaboration opportunities to accelerate the translation of promising research into commercially viable products. The Catapult operates state-of-the-art manufacturing and analytical facilities that function as a key CDMO resource, enabling companies and academic institutions to overcome the technical and logistical hurdles associated with advanced therapy manufacturing. By focusing on industrializing the supply chain, the Catapult plays an instrumental, non-profit role in driving the growth of the cell and gene therapy industry, ultimately aiming to bring innovative treatments to patients more quickly.
Miltenyi Biotec
Miltenyi Biotec is a recognized leader in the European cell therapy sector, known primarily for its advanced cell processing technologies that are integral to manufacturing services. Operating as a specialized CDMO, the company offers a range of services that include the entire development and manufacturing lifecycle for both cell and gene therapy products. Miltenyi Biotec’s core strength lies in providing solutions that automate and streamline complex cell manipulation and processing workflows, such as cell isolation, washing, and enrichment. These technologies are crucial for ensuring the high quality, efficiency, and reproducibility required for clinical and commercial production, making the company a vital provider of scalable manufacturing solutions for biotech and pharmaceutical firms globally.
Cell Therapies
Cell Therapies is a pioneering biotechnology firm specializing in the end-to-end development, commercialization, and specialized manufacturing of cutting-edge cell therapies. The company operates at the forefront of scientific innovation, leveraging state-of-the-art technologies and a multidisciplinary approach to provide comprehensive services. Their expertise spans the entire spectrum of therapy development, encompassing critical stages from initial research and development to cGMP manufacturing and efficient distribution. Cell Therapies actively engages in strategic partnerships, such as developing manufacturing processes for drug candidates like those in Arovella Therapeutics’ pipeline, solidifying its role as a key provider of integrated, specialized cell therapy manufacturing services.
MaxCyte
MaxCyte is a global clinical-stage life sciences company that focuses on accelerating the discovery, development, and high-quality manufacturing of cell-based medicines. While not a traditional CDMO, MaxCyte acts as a critical enabling technology service provider through its proprietary ExPERT™ platform. This platform is a market-leading non-viral cell engineering system utilized by numerous partners in biopharma to create new cell therapy medicines. The ExPERT platform, which includes specialized disposables, is central to streamlining the manufacturing process by ensuring efficient, scalable, and reliable cell modification, thereby supporting the creation of autologous and allogeneic therapies for a range of acute and chronic diseases.
Precigen
Precigen is a biotechnology company that significantly impacts cell therapy manufacturing by developing and providing proprietary technology for scalable production. Their key contribution is the UltraPorator™ system, an exclusive device and software solution designed to enable the rapid and cost-effective manufacturing scale-up of their proprietary UltraCAR-T® therapies. The FDA clearance of the UltraPorator as a manufacturing device for use in clinical trials, compliant with cGMP, underscores its role in the manufacturing services ecosystem. Precigen’s technology offers a streamlined, non-viral approach for the design and production of potent on-target gene and cellular multifunctional therapies, aiding in the industry-wide goal of making advanced cell therapies more accessible and faster to produce.
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