YungShin, founded in 1952, has expanded its global presence since 1978 with affiliates such as Yung Zip Chemical in Taiwan, CTI in the US and YSP Southeast Asia. The company focuses on developing and producing finished pharmaceutical products, APIs and nutraceuticals. YungShin maintains rigorous quality standards, adhering to the SAP ERP system, SOPs, and regulations from PIC/S GMP, Japanese MHLW, and the US FDA. From its Taiwan facilities, YungShin offers CMO/CDMO services and in/out-licensing opportunities.
Wheeler Bio
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.
SyVento BioTech
SyVento BioTech is an innovative biotech partner offering end-to-end capabilities to develop, formulate and manufacture next-generation mRNA-based products and innovative medicines. Leveraging unique know-how and customer-centric flexibility, the company delivers comprehensive services, including preclinical/clinical drug development, RUO/GMP-grade mRNA synthesis, manufacturing of GMP commercial/clinical batches, and aseptic fill & finish—all under one roof. With a state-of-the-art facility located in the EU (Poland), SyVento BioTech specializes in liposomal and LNP technology, providing tailored solutions for the encapsulation and delivery of therapeutic molecules, such as: RNA, DNA, CRISPR, small molecules, proteins and peptides. The company supports customers on each step of the project, including quality control, analytics, bioassay, regulatory support, warehousing and project management. | SyVento BioTech is an innovative biotech partner offering end-to-end capabilities to develop, formulate and manufacture next-generation mRNA-based products and innovative medicines. Leveraging unique know-how and customer-centric flexibility, the company delivers comprehensive services, including preclinical/clinical drug development, RUO/GMP-grade mRNA synthesis, manufacturing of GMP commercial/clinical batches, and aseptic fill & finish – all under one roof. With a state-of-the-art facility located in the EU (Poland), SyVento BioTech specializes in liposomal and LNP technology, providing tailored solutions for the encapsulation and delivery of therapeutic molecules, such as: RNA, DNA, CRISPR-Cas9, small molecules, proteins and peptides. The company supports customers on each step of the project, including quality control, analytics, bioassay, regulatory support, warehousing and project management.
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.
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.
Simtra BioPharma Solutions
As the premier, independently owned CDMO with more than 65 years of sterile injectable manufacturing expertise, Simtra BioPharma Solutions delivers advanced cGMP sterile fill and finish to the highest standard in the industry. Our focused approach is backed by technical rigor, collaborative integrations, and a future-forward mindset designed to support our customers strategic objectives. Biotech and pharmaceutical companies partner with Simtra when they need to take their molecule to market, whether launching their innovation globally, improving their formulation, or proactively mitigating risk to help grow their business. Our teams of tenured experts deliver tailored, flexible solutions to help customers consistently fulfill their product goals at the highest quality, so they get in the hands of the patients who need them most.