Wheeler Bio is a biomanufacturing pioneer, founded by a team of industry experts and strategic investors who believe a different CDMO model is needed to help innovators go faster with new therapeutic candidates. Our novel hub-and-spoke concept, centered in Oklahoma City, will revolutionize the speed of drug development. | Wheeler Bio is a biomanufacturing pioneer founded by a team of industry experts and strategic investors who believe a different CDMO model is needed for innovators to bring new therapeutic leads to the clinic faster, without the risk and cost associated with traditional outsourcing models. Our novel hub-and-spoke concept, centered in Oklahoma City with satellite labs embedded in discovery centers on the coasts, will revolutionize the translational path from discovery to CMC development and first patient dosing. Wheeler’s pioneering, highly-accessible, open-source development platform – Portable CMC® – delivers speed to clinic and uniquely-affordable workflows by integrating discovery CROs and CDMOs. Portable CMC® is a suite-ready drug substance manufacturing platform that customers can transfer to any CDMO in the world with no royalties, licensing fees or penalties. By overlapping with the discovery workflow, Portable CMC® reduces timelines and regulatory risks through the introduction of QbD (Quality-by-Design) principles earlier on in the drug development life cycle, increasing the opportunity for clinical success.
Wacker Biotech
WACKER BIOTECH is “THE MICROBIAL CDMO” – your partner of choice for process development and contract manufacturing of biopharmaceuticals (proteins, vaccines, live microbial products, plasmid DNA (pDNA)) using microbial hosts. Additionally, WACKER BIOTECH provides R&D and GMP manufacturing services for advanced therapies as a one-stop-shop: from the production of plasmid and template DNA as starting material for mRNA through the IVT of mRNA and LNP formulation, the nucleic acid expertise of Wacker Biotech combined with the lipid expertise of our partner CordenPharma ensures the best possible results for each of our client’s mRNA-focused projects. WACKER BIOTECH’s integrated service portfolio covers molecular biology, process / analytical development as well as GMP manufacturing of biologics for clinical and commercial supply. WACKER BIOTECH operates four state-of-the-art GMP facilities located in the U.S., Germany and The Netherlands. Manufacturing lines are equipped with stainless steel fermentation vessels from 350 to 1500 liter as well as single-use bioreactors. Matching primary recovery, downstream and Fill & Finish capabilities are available to suit various clients’ needs across the development path (BSL 1 and 2). Additionally, a GMP cell-bank suite enables independent cell-bank production and storage capacity for client cell banks. In 2022 the German government selected Wacker Biotech and CordenPharma as joint bidders for the stand-by production of vaccines based on mRNA. Therefore, WACKER is now building a state-of-the-art mRNA competence and manufacturing center at its existing Halle, Germany site to complement its other existing sites in Jena, Germany, Amsterdam, the Netherlands and San Diego, California. The new capabilities at Wacker Biotech Halle will support end-to-end manufacturing of plasmid DNA, mRNA and LNP formulation under one roof. WACKER BIOTECH holds biomanufacturing certificates from the relevant authorities for all sites and follows the ICH Q7A guidelines for GMP-compliant production of biologics. The GMP production facilities in the Netherlands and Germany are approved by the EMA, U.S. FDA and/or ANVISA for commercial manufacturing. The WACKER BIOTECH U.S. site is currently preparing for a U.S. FDA inspection. Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly-owned subsidiaries of Munich-based Wacker Chemie AG. | WACKER BIOTECH is the CDMO partner of choice for process development and manufacturing of biopharmaceuticals (therapeutic proteins, vaccines, live biotherapeutic products) based on microbial systems and for the entire manufacturing chain of pDNA, mRNA and lipid nanoparticle formulations. Our clients benefit from our decades of experience in complex protein-based therapeutics, vaccines, and specialty chemicals sectors, including partnering with the German government to respond to the Covid-19 pandemic. WACKER BIOTECH operates five state-of-the-art GMP facilities located in the U.S., Germany and The Netherlands. Manufacturing lines are equipped with stainless steel fermentation vessels from 350 to 1500 liter as well as single-use bioreactors. Matching primary recovery, downstream and Fill & Finish capabilities are available to suit various clients’ needs across the development path (BSL 1 and 2). WACKER BIOTECH provides R&D and GMP manufacturing services for advanced therapies as a one-stop-shop: from the production of plasmid and template DNA as starting material for mRNA through the IVT of mRNA and LNP formulation, the nucleic acid expertise of Wacker Biotech combined with the lipid expertise of our partner ensures the best possible results for each of our client’s mRNA-focused projects. In Amsterdam, NL, we jump-started mRNA manufacturing during the COVID-19 pandemic, making us a leading CDMO with hands-on GMP manufacturing experience of mRNA-based therapies, including validation GMP runs. With the addition of another cutting-edge competence center for mRNA actives in Halle, Germany, we have increased our RNA product manufacturing and LNP formulation capacity. In this dynamic field of advanced therapies, you will benefit from experienced, reputable partners validated by the German government. In close collaboration with universities and research institutions, WACKER’s corporate R&D team of over 200 researchers continuously develops new production platforms and technologies for all types of biopharmaceuticals, including pDNA, mRNA and LNPs. Competitive, outstanding solutions are our trademarks. Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly-owned subsidiaries of Munich-based Wacker Chemie AG. | Wacker Biotech is the expert biologics CDMO partner for process development and manufacturing of advanced therapies and vaccines, as well as live microbial products and recombinant proteins based on microbial systems. Our nucleic acid-based capabilities span the full manufacturing value chain, from the production of plasmid and template DNA as a starting material for mRNA through the IVT of mRNA to lipid nanoparticle (LNP) formulation. We have the capability to produce at diverse scales up to 1500 L and recently quadrupled our mRNA production capacity with the completion of a new mRNA competence center in Halle, Germany. In Wacker Biotech, you have a flexible partner delivering science-driven solutions and guidance from concept to commercialization. We operate five GMP manufacturing facilities in Germany (Halle and Jena), the Netherlands (Amsterdam) and the US (San Diego). Complementing our bioprocess development and manufacturing experts at these four sites is a team of dedicated research scientists leading continuous innovations and collaborations at our parent company’s R&D hub in Munich, Germany. Wacker Biotech is wholly owned by Munich-based Wacker Chemie AG, a publicly traded company founded in 1914 that pioneered some of the 20th century’s leading chemistry advances. We have 30+ years of experience developing biologics to advance human and animal health. | Wacker Biotech is the expert biologics CDMO partner for process development and manufacturing of advanced therapies and vaccines, as well as live microbial products and recombinant proteins based on microbial systems. Our nucleic acid-based capabilities span the full manufacturing value chain, from the production of plasmid DNA as a starting material for RNA, to the IVT of RNA, to lipid nanoparticle (LNP) formulation. We also produce >97% supercoiled plasmids for AAV and LV delivery, and for direct application. In Wacker Biotech, you have a flexible partner delivering science-driven solutions and guidance from concept to commercialization. Our global footprint encompasses five GMP manufacturing facilities in Germany (Halle and Jena), the Netherlands (Amsterdam) and USA (San Diego), able to produce at diverse R&D, HQ and GMP grades, with scale-up to 1500 L. Complementing our bioprocess development and manufacturing experts at these sites is a team of dedicated research scientists leading continuous innovations and collaborations, and also providing nucleic acid contract research services, at our parent company’s R&D hub in Munich, Germany. Wacker Biotech is wholly owned by Munich-based Wacker Chemie AG, a publicly traded company founded in 1914 that pioneered some of the 20th century’s leading biochemistry advances. We have 30+ years of experience manufacturing biologics to advance human and animal health.
Vetter
Vetter is a global leading contract development and manufacturing organization (CDMO), headquartered in Ravensburg, Germany, with production facilities in Germany, Austria and the United States. The company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early stage development support including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes and cartridges. As a leading solution provider, Vetter appreciates its responsibility to support the needs of its customers by developing devices that contribute to increased patient safety, convenience, and compliance. Great importance is also given to social responsibility including environmental protection and sustainability. Learn more about Vetter at www.vetter-pharma.com. | Vetter is a global leading contract development and manufacturing organization (CDMO), headquartered in Ravensburg, Germany, with production facilities in Germany, Austria and the United States. The company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early stage development support including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes and cartridges. As a leading solution provider, Vetter appreciates its responsibility to support the needs of its customers by developing devices that contribute to increased patient safety, convenience, and compliance. Great importance is also given to social responsibility including environmental protection and sustainability. | Vetter is a leading Contract Development and Manufacturing Organization (CDMO) with headquarters in Ravensburg, Germany, and production facilities in Germany, Austria, and the US. As a global player, the independent pharmaceutical service provider is also present in the Asia-Pacific markets of Japan, China, South Korea and Singapore with sales locations. Around the world renowned pharma and biotech companies benefit from decades of experience, high quality, modern technologies, reliability, and commitment of its 7,300 employees. In close collaboration with its customers, the Vetter team helps enable the supply to patients all over the world with medicines, many of which are vital. The CDMO provides support from drug product development through clinical and commercial filling to a wide range of assembly and packaging services for vials, syringes, and cartridges. With innovative approaches, Vetter develops prefilled drug-delivery systems together with its customers to continuously improve patient safety, comfort, and compliance. Vetter takes responsibility for sustainable practices and operates as a socially and ethically responsible corporate citizen. The CDMO is a member of the UN Global Compact and Science Based Target initiative (SBTi) and received platinum status in the renowned EcoVadis ranking. Multiple awards such as the CDMO Leadership Awards, Frost & Sullivan Customer Value Leadership Award and the recognition of Best Managed Company emphasize Vetter’s commitment to sustainable business. Founded in Ravensburg in 1950, the company remains family-owned to this day. For more information, visit www.vetter-pharma.com and follow Vetter on LinkedIn.
Touchlight DNA Services
Touchlight is a privately-owned CDMO based in London, U.K., focused on the provision of DNA services and manufacture of enzymatically produced doggybone DNA (dbDNA) to enable the development of genetic medicines. Touchlight provide rapid, enzymatic DNA development and manufacturing for all advanced therapy production, including mRNA, viral and non-viral gene therapy and DNA API. dbDNA is a minimal, linear, covalently closed structure, which eliminates bacterial sequences. Touchlight’s revolutionary enzymatic production platform enables unprecedented speed, scale, and the ability to target genes with a size and complexity that is impossible with current technologies. Clients can be supported from pre-clinical through development and supply, to licencing and tech transfer for use in-house. | Touchlight is an innovation-driven leading CDMO pioneering enzymatic GMP DNA production to enable the genetic medicine revolution. As pioneers, with an FDA Drug Master File accepted in 2022 followed in 2025 with the world’s first cell-free DNA GMP license, Touchlight’s enzymatic DNA technology is on the cutting edge of AAV, mRNA, DNA vaccine, and gene editing technology with its state-of-the-art facility recognised by ISPE’s Facility of the Year Awards (FOYA) for Innovation. With multiple client products already in the clinic, Touchlight’s evidence-based, synthetic DNA manufacturing solutions offer a scalable, sustainable alternative to plasmid DNA (pDNA) for all stages of pre-clinical, clinical and commercial development. The company and technology are built on the conviction that DNA is fundamental to the future of medicine. Traditional methods, based on bacterial fermentation, are slow, costly, and unable to meet the growing demands of genetic medicine due to limited scalability and speed. Founded in 2007, Touchlight’s team is inspired by breakthroughs in genetic medicine, recognising the urgent need for innovative DNA production techniques to support the future of genetic therapies.
Thousand Oaks Biologics Inc.
Thousand Oaks Biologics Inc. (Hereinafter referred to as TOBio) is a CDMO enterprise integrating cell culture media, biopharmaceutical development and contract manufacturing related business. It providing customers with one-stop-shop service for biologics including druggability assessment, cell line development, process development and optimization, manufacturing services from early stage to commercial, IND filing and NDA filing, etc. TOBio has extensive experience in development and manufacturing of monoclonal antibody (mAb), bispecific antibody (BsAb), antibody-drug conjugate (ADC), Fc fusion proteins, and other recombinant protein products in the field of therapeutic biological products. It has successfully delivered nearly 100 biologic CMC projects, TOBio is one of the few CDMO which has successfully passed the pre-approval registration of products and GMP compliance on-site inspection. TOBio industry-leading technical experts with many decades of CMC experience is one of the key drivers that enables accelerated project timelines and reduction of the costs for clients. TOBio has the manufacturing capacity of 200L, 500L and 2,000L of Traditional Fed Batch and Intensified Fed Batch, as well as Concentrated Fed Batch and Perfusion technology in China. The drug product facilities currently capable of conducting liquid or lyophilized fills at varying clinical and commercial scales and utilizing a variety of container and closure system configurations that include vials, prefilled syringes. TOBio advanced CDMO platform with a complete quality management system can meet US FDA, EU EMA, China NMPA, and other countries’ regulatory standards. | Thousand Oaks Biologics Inc. (TOBio) is a premier provider of comprehensive solutions for the large – scale, compliant production of biopharmaceuticals. Its business portfolio encompasses three key segments: the biopharmaceutical CDMO segment, the cell culture medium segment, and the early – stage research service segment. In the biopharmaceutical CDMO realm, TOBio offers end – to – end CMC solutions, guiding candidate molecules through the entire journey from discovery to clinical and commercial production. Currently, the company has established GMP – compliant production bases in Shanghai. These facilities are equipped to offer one – stop R & D and manufacturing services for a diverse range of biopharmaceuticals, including monoclonal antibodies, bispecific antibodies, fusion proteins, and ADCs. TOBio houses JSBio, a leading domestic brand in serum – free cell culture media. JSBiosciences, a key player in this segment, is dedicated to the research, development, production, and marketing of serum – free, personalized, and chemically – defined cell culture media. In addition to product – related services, JSBiosciences also provides clients with comprehensive upstream solutions, such as cell culture process development and scale – up, as well as customized production of medium formulations. With production bases in china and South Korea, JSBiosciences has achieved an annual production capacity in the kiloton range. Its products and technical services find extensive applications in the production of recombinant proteins, antibody – based drugs, human and veterinary vaccines, and cell therapy products. The early – stage research service segment is propelled by Ginspire Biologics, which is based in Shanghai. Ginspire, specialized in early – stage research, offers a suite of services for innovative molecules in various forms. These services include molecular design, evaluation, optimization, and structural and functional characterization. By collaborating with clients to develop unique innovative molecules or licensing out its self – developed molecules as required, Ginspire conducts multi – dimensional assessments and optimizations in terms of structural function, pharmacology, efficacy, and drug – likeness. This approach significantly enhances the success rate of developing complex innovative molecules, facilitating the efficient progression of promising molecules to the next development phase. | Thousand Oaks Biologics Inc. (TOBio), a premier Integrated CMC Solution Provider, focuses on comprehensive solutions for large – scale, compliant biopharmaceutical production. Its business covers three main segments: Biopharmaceutical CDMO, Cell Culture Medium, and Early – Stage Research Services. Its products and technical services find extensive applications in the production of recombinant proteins, antibody – based drugs, human and veterinary vaccines, and cell therapy products. In CDMO, TOBio offers end – to – end CMC solutions at its Shanghai and Nantong GMP bases, serving diverse biopharmaceuticals. JSBio, under TOBio, excels in serum – free cell culture media, providing R&D, production, and customized services with kiloton – scale capacity across China and South Korea. Ginspire Biologics drives early – stage research, offering molecular design, evaluation, and optimization to boost complex molecule development success. This dedication across its business segments underscores TOBio’s unwavering commitment to making biologics more accessible and affordable for humanity.
Taiwan Contract Research One-Stop Service
(1) To establish a leading preclinical R&D alliance in Taiwan. (2) To integrate the core strengths of five major R&D institutions in Taiwan: National Center for Biomodels (NCB) of the National Institutes of Applied Research, Biomedical Translation Research Center of Academia Sinica, Industrial Technology Research Institute (ITRI), Development Center for Biotechnology (DCB), and National Health Research Institutes. (3) To provide a complete one-stop CRO service, accelerating the translation and industrialization of innovative achievements in biotechnology and medicine.
Taiwan Bio-Manufacturing Corporation (TBMC)
Enabling reliable development and manufacturing of advanced therapies and complex biologics through a next-generation CRDMO platform. Taiwan Bio-Manufacturing Corporation (TBMC) is a Taiwan-based pure-play CRDMO focused on supporting global pharmaceutical and biotechnology partners in advancing next-generation therapeutics. Built upon Taiwan’s strong biotechnology research foundation and world-class manufacturing ecosystem, TBMC integrates experienced GMP expertise with advanced production technologies. TBMC provides end-to-end CRDMO solutions across cell therapy, mRNA therapeutics, viral vectors, plasmid DNA, and complex biologics including ADCs and bispecific antibodies. With modular, flexible, and digital GMP facilities, strong IP protection, and an Asia-based manufacturing presence, TBMC enables global partners to accelerate development timelines, scale manufacturing capacity, and support regulatory compliance across international markets. Partner with TBMC to strengthen your global manufacturing strategy for next-generation therapies.
Taiwan Cell Manufacturing Co. Ltd
At Taiwan Cell Manufacturing Co. (tcmc), we specialize in delivering premium-quality lentiviral vectors (LVVs) and cell therapy products tailored to meet your needs. LVVs play an important role in genetic engineering of T cells, and we offer advanced solutions for LVV manufacturing to support gene-editing T cells, from R&D to full-scale commercialization. Our expertise also extends to the manufacturing of non-genetically modified cells as well, including DC, NK and stem cells. We understand the complex world of compliance, so every CDMO service we provide is accompanied by robust regulatory support for your CMC package. From groundbreaking research to life-changing therapies, tcmc is your trusted partner in developing next generation therapies.
Symbiosis
Symbiosis Pharmaceutical Services is a contract manufacturing organisation (CMO) specialising in the GMP manufacture and sterile fill/finish of vials for clinical trials and commercial supply. Regulatory compliance, technical capability and operational flexibility are at its core. Manufacturing from a purpose-built FDA inspected and MHRA-licensed facility, the CMO can handle products that require aseptic liquid filling and lyophilisation for a range of complex biologics, viral vectors for use in gene therapies and small molecule drugs. Offering fast access to manufacturing slots and accelerated release of drug product, Symbiosis is primed to meet demand for small-scale, fast-turnaround drug product sterile manufacturing. | Symbiosis is a global, client-focused, contract manufacturing organisation (CMO) offering GMP aseptic manufacture for clinical trials through to commercial supply. Utilising batch strategies closely aligned with the latest regulatory framework, Symbiosis empowers drug developers to meet their project milestones through rapid access to fill-finish slots. Our purpose-built, FDA-inspected and MHRA-licensed manufacturing suites are designed with cytotoxic APIs in mind. Working with liquid and lyophilised formulations, our expert in-house team has over ten years of experience in taking a wide range of from drug substances to QP release e.g. mAbs, vaccines, small molecules, ADCs, ATMPs, etc. As trusted partners, Symbiosis are dedicated to supporting our clients facilitate safe, life-saving injectable drug therapies, without delay. Get in touch to begin your fill-finish program. | Symbiosis is a global contract manufacturing organisation (CMO) offering drug product GMP aseptic manufacture for clinical trials through to commercial supply. Closely aligned with the latest regulatory framework including Annex 1 and BSL-2, Symbiosis empowers drug developers to meet their project milestones through rapid access to fill-finish slots. Our purpose-built, FDA-inspected and MHRA-licensed manufacturing suites are designed to accommodate cytotoxic APIs. Working with liquid and lyophilised formulations, our expert in-house team handle a range of modalities from drug substance to QP release e.g. mAbs, vaccines, small molecules, ADCs, ATMPs, etc. As trusted partners, Symbiosis are dedicated to supporting our clients facilitate safe, life-saving injectable drug therapies, without delay.