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.
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.
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.
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.
Space Peptides
Headquartered in Switzerland with global operations, Space Peptides provides End-to-End pharmaceutical Peptide CRDMO services at Premium Speed & Quality – covering discovery, process development, and GMP manufacturing. In addition, our portfolio comprises a broad range of generic Peptide APIs.
Sikich
Sikich LLP is a business and technology consultancy who’s close to 1,500 team members provide advisory, consulting, and technology services to clients in life sciences, manufacturing, professional services, and other industries. The company’s life sciences practice spans the industry and supports more than 200 life sciences clients, including biotechnology and biopharmaceutical companies, CROs, and lab diagnostic companies. As a leading life science technology consultant, we can help you streamline operations and ensure compliance, allowing stakeholders to do what they do best: develop new medicines for patients who need them. | At Sikich, we empower life sciences organizations through strategic planning, regulatory expertise, and digital modernization. From inception to commercialization, we specialize in planning, regulatory, quality, and compliance, leveraging cutting-edge technologies like Oracle NetSuite, Honeywell’s TrackWise Digital, and Kneat’s solutions to streamline operations and accelerate innovation. Our tailored approach combines deep industry knowledge with advanced digital tools, ensuring compliance, enhancing efficiency, and reducing time-to-market for life-changing therapies. A focus on built in audit trails, roles-based control and automated reporting ensure compliance with FDA 21 CFR Part 11, SOX and EU Annex 11. With a commitment to precision, integrity, and transformation, we help companies navigate complex regulatory landscapes and embrace the future of life sciences with confidence. Plan smarter. Modernize faster. Innovate with impact.
Shanghai Taichu Biotechnology Co., Ltd.
Taichu group was founded in 2020, providing contract research, development and manufacturing services to pharmaceutical and biotech companies. Our service platforms include early discovery and design of complex antibodies such as multispecific antibodies, nanobodies, fusion proteins etc. Our GLP- and AAALAC- certified animal facility provides preclinical studies (PK/PD), safety evaluation (Toxicology) for a various modality of drug candidates, such as small molecules, biologics, ADC, CGT products, and RNAi, ASO, mRNA molecules. For development and manufacturing of complex antibodies, our CDMO (Tarlead) has experienced teams, well-established laboratories and facility for process development, drug substance production and drug product manufacturing, ready to meet your needs and timelines. | Taichu Group is a biotechology enterprise with a core advantage in “CRO+CDMO integrated services”, providing end-to-end solutions for global innovative drug development from early discovery through preclinical research. Headquartered in Shanghai’s Lingang Special Area, the Group operates through its subsidiaries: Taichu Bio (Pre-Clinical Research), AceMab Ltd (Antibody Discovery & Design), Tarlead Biologics (Biologics Development & Manufacturing), TJR Bio (Nucleic Acid Drug Process & Manufacturing), and Taichu (Shenzhen) (Innovative Therapeutic Development Advisory). Guided by the philosophy “Advocate of Ethics and Integrity, Quest for Verity”, we streamline R&D workflows and accelerate therapeutic advancement for global partners. Our synergistic service model bridges key gaps between discovery and commercialization, reinforcing our role as a strategic enabler in the biopharmaceutical innovation value chain.
SEKISUI
BioProduction by SEKISUI describes SEKISUI’s contract service offering as a microbial focused CDMO with expertise in proteins and downstream purification. Our fermentation process development and production experience helps smooth technical transfer and process scale up. Our core competencies include E.coli and yeast fermentation, plant protein extraction, large scale bioprocessing, protein purification, bulk formulation, lyophilization and analytical testing. Our production site in the UK has been a leader in the manufacturing of high-quality proteins and specialty biochemicals globally to the healthcare market for over 40 years. We have worked with many global partners to supply high quality materials for a variety of applications, including proteins for biotherapeutics, pharmaceuticals, and diagnostic medical devices. | SEKISUI Medical Group is a diverse, global network consisting of a diagnostics business and pharmaceutical sciences business which spans drug development services and manufacturing, including active pharmaceutical ingredients and pharmaceutical intermediates, amino acids, as well as a wide range of enzymes for use in diagnostics, and biopharmaceutical contract manufacturing and more BioProduction by SEKISUI is a trusted provider of specialized CDMO services, offering biomanufacturing solutions built on decades of experience in microbial fermentation and downstream processing. We support the full development lifecycle—from strain optimization to clinical-scale manufacturing—catering to a wide range of biologics including enzymes, recombinant proteins, antibody fragments, viral vectors, and plasmids. Our microbial expertise spans multiple expression platforms including E. coli, Pichia pastoris, Bacillus, Streptomyces, Streptococcus, fungi, and yeast, enabling highly flexible and efficient process development for biologics. Our advanced UK facility based in Kent is equipped for full spectrum biomanufacturing services and features: Fermentation capacity from 2 L R&D scale up to 5,000 L production Integrated protein expression services for high-yield production Advanced chromatography and purification suites End-to-end antibody production services Lyophilization and bulk formulation GMP-aligned systems under ISO 9001 and ISO 8 cleanroom classifications In-progress GMP plasmid manufacturing and clinical-grade expansion Environmental control and zero-emissions sustainability framework We also provide expert plasmid production for research and therapeutics, with growing capabilities in viral vector manufacturing for cell and gene therapy markets. As established recombinant protein manufacturers, we support custom expression and scale-up for diverse biopharmaceutical programs. In cell and gene therapy, SEKISUI is committed to enhancing the reliability, scalability, and efficiency of cell culture. Ceglu™, our lead technology, is a chemically defined, synthetic matrix that provides a stable, feeder-free environment for culturing stem cells (iPSCs, ESCs, MSCs). To accommodate diverse workflows, Ceglu™ is available in two formats: ready‑to‑use pre‑coated culture ware for research workflows, and an automation‑friendly coating solution for cell manufacturing workflows which can be precoated and sterilized onto closed systems or bioreactor consumables for seamless cell production. With a focus on advancing regenerative medicine, SEKISUI partners with service providers, biopharma organizations, bioprocessing innovators and academia to deliver solutions that meet the evolving needs of the industry. Drop by our booth 5621 to ask us about our GMP-readiness, room temperature storage and iPSC.