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.
VintaBio
VintaBio is enabling a new approach to viral vector manufacturing that delivers higher yield, greater process control, and scalable output within a compact footprint. We are actively seeking partners and investors aligned with advancing next-generation manufacturing solutions for gene therapy and vaccine production — particularly those looking for improved control, efficiency, and scalability without the infrastructure burden of traditional systems. VintaBio has successfully executed GMP manufacturing for ocular AAV programs, demonstrating the ability to translate its adherent manufacturing approach into clinical-stage production. In parallel, the company is engaged in active pipeline discussions for viral vaccine development, including programs aligned with U.S. government initiatives supporting domestic manufacturing, emergency preparedness, and on-shoring of critical health infrastructure. Our differentiated adherent manufacturing approach addresses a core industry tradeoff: achieving scale without sacrificing product quality or process consistency. By combining biological fidelity with process control, VintaBio delivers: • Higher yield and more consistent product output • Reduced impurity burden and downstream complexity • Greater control over production conditions and timing • Reliable clinical supply and predictable timelines • Scalable production without expanding manufacturing footprint This approach has been successfully demonstrated in clinical manufacturing and is inherently reproducible, enabling a capital-efficient, multi-site growth model. We are engaging with: • Biopharma partners seeking greater control over viral vector manufacturing and improved process performance • Strategic and financial investors focused on scalable biomanufacturing platforms • Global partners advancing domestic manufacturing capacity for vaccine preparedness and healthcare resilience VintaBio is positioned at the intersection of increasing gene therapy demand and global investment in domestic manufacturing capacity — offering a differentiated, scalable solution to one of the industry’s most critical bottlenecks.
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.
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.
STC Biologics
WHO ARE WE STC Biologics, Inc is a fully integrated CDMO located in Newton MA, USA that provides full CMC Services and Consulting for drug developrs to advance their biologic products from discovery to commercialization. Founded in 2009, the Team brings deep expertise in biologics drug development and global regulatory approvals from a “who’s who” list of companies like Genentech, Novartis, Shire, EMD Serono, Lonza, Alexion and Merrimack. The holistic view of drug development with the integration of biology into CMC development, and the cross-training of its scientists in those diverse fields is what makes STC unique in its ability to expedite timelines to the clinic. STC strives to REALIZE “SPEED TO CLINIC” THROUGH INTEGRATED PRODUCT DEVELOPMENT, TECHNICAL RIGOR, AND FLEXIBILITY. CORE COMPETENCIES STC Biologics’ core competencies center on biologics drug development starting from cell line generation for high expression levels, process, analytical and formulation development to GMP production. The technical and regulatory know-how at STC Biologics enables integrated product development planning and successful maneuvering through inevitable development challenges. STRATEGY STC has established its reputation as a flexible organization that clients can turn to for accelerated low-cost programs through our Speed-To-Clinic Platform™, or for custom development when template processes don’t meet the needs of complex products. STC introduced Speed-To-Clinic Platform™ for MAbs starting from royalty free Cell Line Development directly to cGMP Manufacturing and released Drug Substance, all within a 12-month cycle – even for challenging proteins. DEVELOPMENT & COMMERCIALIZATION Having written over 8 BLAs, dozens of INDs, & 20 comparability protocols & supplemented by experience in the life cycle management of 5 approved biologics, our management team is uniquely positioned to guide our clients to develop an integrated CMC plan tied to preclinical & clinical development with an eye on regulatory expectations. During the last five years, we have advanced our first biosimilar product, STC101, from concept to clinical development in Europe under the EMA guidance. We have also helped our clients overcome complex process & analytical challenges through rigorous & customized efforts. Why work with STC? Executive Team with over 100 years in the industry; Over 100 assays developed; 18 INDs filed; 8 BLAs filed. By Phase With experience in all phases of product development for a range of biotherapeutics and commitment to advance the products through development, STC Biologics is your preferred strategic partner. We take pride in our ability to become an expert on your product, to go above and beyond in order to drive it through various stages of product development and ultimately successfully tell the story of your product in regulatory submissions. By Service The time and cost savings of an integrated approach to developing products, not constrained by the boundaries of different departments, has been realized in smart cross-functional organizations. STC Biologics, Inc. is founded on such boundary-less merge of disciplines, as the knowledge of biology, process development, analytics, formulation, and regulatory sciences is in one team body. Our pride in technical rigor, perseverance, critical thinking, and multidisciplinary collaborative work ethics bring agile resolution to technical hurdles and nimble development of products. At STC Biologics, we specialize in providing end-to-end solutions for biopharmaceutical development and manufacturing. Our team of experts is dedicated to delivering high-quality and innovative services, including: • Cell Line Development: Customizable and efficient cell line development tailored to meet your specific requirements – high-titer results o For complex molecules (e.g. multi-specifics): developability, manufacturability, high-order analytics • Process Development: Comprehensive process development, optimization, and scale-up for both upstream and downstream processes. • Analytical Services: Robust analytical testing and characterization to ensure product quality and compliance with regulatory standards. • Formulation development: Complex, sensitive and high concentration formulations • cGMP Manufacturing: State-of-the-art cGMP manufacturing facilities for clinical production. • Bioconjugation chemistry for: ADCs, radiopharmaceuticals, Oligos Leadership: Dr. Magdalena Leszczyniecka, PhD. MBA. President and CEO of STC Biologics Email: magda@stcbiologics.com Magdalena founded STC Biologics Inc. in 2009 with a goal to bring biosimilar products to patients who cannot afford branded equivalents. Since 2009, STC has worked on four biosimilar antibody products, some being developed in-house and others for STC’s partners. As a leader in the biosimilar sector, she presents at key biosimilar business conferences each year, is an strategy advisor to Sectoral Asset Management and consults on biosimilars for Coleman Research (a company focused on providing market research for buy-side investors). She has three patents relating to biosimilar product optimization, covering methods to achieve fingerprint-like similarity in product quality. STC’s main goal is to bring a biosimilar product to the market with reduced burden of clinical trials by providing fingerprint analytical data on product similarity. Magdalena has a broad drug development experience in small molecules and various biologics including IgG1, IgG4, two Fc fusion proteins, antibody single chains, and antibody targeted liposomal formulations. She gained start up experience prior to STC working for venture capital firms: Flagship Ventures and Atlas Ventures. She has led the development of MM-121 and anti-HER3 antibody programs at Merrimack Pharmaceuticals. In 2002, she started her scientific career at Novartis Pharmaceuticals as a project leader for two oncology development products. She received her Ph.D. from a joined program between Columbia University and NYU, an MBA from Babson College, and a B.S in Biochemistry from Rutgers University. Dr. Zahra Shahrokh, PhD. Chief Development Officer at STC Biologics Email: zshahrokh@stcbiologics.com Zahra brings a broad experience in biotechnology product development with a track record in global regulatory approvals of 5 biological products (Replagal, Elaprase, Dynepo, VIPRIV, Firazyr) and in the clinical development of dozens of novel biologics. She has more than 25 years experience in biopharmaceutical development: 10 years at Genentech as Senior Group Leader in Pharmaceutical Development and CMC team leader, 10 years at Shire HGT as both Head of Pharmaceutical and Analytical Development and then Head of CMC Program Management, followed by another 4.5 years as a CMC consultant. At STC Biologics, she provides strategic and technical leadership for the development of internal and client products, including biosimilars, antibody based products, viral products, and targeted liposomal products. At Shire, she built organizational capabilities throughout the company’s growth phase from a start-up company (known as TKT) towards a multi-billion dollar commercial organization. She had oversight of formulation & drug product manufacturing process development, tech transfer, analytical development & process development analytical operations, specifications development & comparability, product characterization, and clinical GMP testing & stability programs. Furthermore, she held roles such as Chair of Quality Standards Committee and Program Executive for the CNS projects, at Shire. She designed and instituted Shire’s first CMC Program Management system to transform the effectiveness of product development teams. She was a CMC representative in regulatory agency meetings, formulated responses to questions, and managed implementing CMC strategy within the department. She had technical and leadership roles at Genentech’s Pharmaceutical R&D department, and prior to that at Scios Nova, where she drove pharmaceutical development of several classes of biologics and small molecules. Zahra has a post-doctoral fellowship at UCSF, PhD in Biophysics from University of California, Berkeley and a dual BA degree in Chemistry and Physics from University of Pennsylvania, Philadelphia. She holds several pharmaceutical patents and over 60 papers and invited presentations. For the past 10 year she has been an invited lecturer in Biotechnology at the University of Kansas, Pharmaceutical Chemistry department, and an active member of the Organizing Committee for WCBP and “CMC Strategy Forum” that brings together regulators and biotech industry to present and debate current topics in product development in the context of globalization and regulatory sciences.