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.
simAbs
simAbs is an EU based manufacturer of monoclonal antibodies. With our proprietary platform we are revolutionizing biomanufacturing with continuous flow technology. SimAbs provides the full range of services and support for biologics development and GMP manufacturing, specializing in sustainable biomanufacturing technologies. We are EU-GMP accredited. We are successfully delivering pre-clinical and clinical phase products. Our way to collaborate is flexible and always tailored to meet your business goals. Recently we have expanded our business into US and India and are looking for additional partnerships for global expansion.
Scorpius BioManufacturing
Scorpius BioManufacturing is a CDMO with integrated, end-to-end solutions for large molecule cGMP manufacturing, process and analytical method development, product characterization, and release testing needs. We currently have capacity for mammalian, microbial, CGT clinical manufacturing projects at our facility in San Antonio, TX. | Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein and cell therapy modalities. Our facility in San Antonio, Texas specializes in working with start-ups, emerging biotechs, and academic researchers. Scorpius was founded by a serial biotech entrepreneur determined to make small-volume programs a big priority. Clients benefit from decades of expertise taking large molecule drugs to market and can rely on Scorpius to offer: Quality, Speed, Flexibility, & Responsiveness. Our capabilities include: • Up to 500-L scale for mammalian-based products • Up to 200-L scale for microbial-based products • ~8,600 sq. ft. of cGMP cleanroom manufacturing space • Dedicated cGMP cleanrooms for cell therapy programs • On-site analytical development and QC support • Process development services | Scorpius BioManufacturing is a U.S.-based and U.S.- owned biologics CDMO providing CGMP manufacturing, bioanalytical, and process development services for protein modalities. Our team in San Antonio, Texas specializes in supporting biotechs, academic researchers, government-funded programs with early-stage clinical and rare disease commercial manufacturing. Our facility has separate buildings for mammalian and microbial systems. Scorpius’ team has experience with with protein conjugations, monoclonal antibodies, vaccines and autologous cell therapy programs across all phases of product development including commercial product. Clients benefit from decades of expertise taking large molecule drugs to market and can rely on Scorpius to offer quality, speed, and flexibility with capabilities including: • Recombinant therapeutic proteins • Enzymes • Bacterial subunit vaccines • Plasmid DNA • Antibodies (mAbs and bi-specifics) • Autologous cell therapy • Fc-fusion proteins
SCIWIN Laboratories Co., Ltd
Custom Organic Synthesis Biopharmaceutical Providing CRO & CMO services for API manufacturers and new drug companies ADC-Novel linker-Payloads Organic synthesis-Small molecule & macromolecule Custom synthesis-reference & impurity standard Technology transfer-Lab to GMP manufacturer Professional Custom Synthesis Services to Meet Your Drug Development Needs SCIWINLAB specializes in providing high-quality custom synthesis services, covering synthesis and process development from small-scale (milligram-level) to large-scale (kilogram-level) production. Our R&D team possesses 10 to 20 years of GMP experience in the pharmaceutical industry, excelling in process optimization and ensuring smooth technology transfer to GMP facilities for scale-up production. With our expertise in organic synthesis, we are committed to delivering reliable and efficient solutions to our clients. To date, we have successfully assisted multiple pharmaceutical companies in transferring technology to GMP facilities, completing the scale-up of five products, and accelerating their market entry. | Custom Organic Synthesis Providing CRO Contract Manufacturing Organization) & CMO (Contract Development and Manufacturing Organization) services for API (Active Pharmaceutical Ingredients) manufacturers and new drug companies ADC-Novel linker-Payloads Organic synthesis-Small molecule & macromolecule Custom synthesis-reference & impurity standard Technology transfer-Lab to GMP manufacturer
ScinoPharm Taiwan, Ltd
ScinoPharm targets following segments in the global pharmaceutical industry: 1. Injectable CRO/CMO for cytotoxics and peptides 2.Payload Linker Synthesis 3. Peptide-Drug Conjugates (PDC), Antibody-Drug Conjugates (ADC), and High Potency APIs (HPAPIs) CDMO service
SCHOTT MINIFAB
SCHOTT MINIFAB provides integrated services for contract design, development and manufacturing of diagnostic and life science consumables – innovation to help you introduce new discoveries, enable precise health care treatments and improve patients outcomes. | SCHOTT MINIFAB provides contract design, development, and manufacturing services for companies in the diagnostics and life science industries. Our team of experts has a deep understanding of the industry-specific challenges and offers innovative solutions that drive cost-efficiencies and facilitate innovation. We specialize in streamlining the process from product development to pilot line to high-volume manufacturing of diagnostic or life science research consumables, with a focus on glass and polymer microfluidics and microarrays. | SCHOTT MINIFAB is your proven partner in contract design, development, and manufacturing for life science research and diagnostic consumables. We understand the hurdles in bringing novel innovations to full commercialization, so we have developed a process and infrastructure to meet your performance, quality, and cost requirements. Seamlessly transitioning from development to manufacturing, your product journey to improve patient care or to advance scientific discovery is closer to reality.
SARTORIUS XPRESS BIOLOGICS
Sartorius Xpress Biologics (SXB) is a biotech company proposing contract services for the production of recombinant proteins, antibody fragments and plasmid DNA for preclinical and clinical applications specific to the therapeutic, vaccine and diagnostic markets (human & veterinary). Both, the production scale (from 100 mg up to 40 g) and the quality of the biologics (R&D, GLP and GMP grade material) proposed by Sartorius Xpress Biologics are adapted for in vitro and in vivo pre-clinical and clinical validation of the biologics (proof-of-concept, early safety, potency, efficacy, Tox…). Moreover, Xpress Biologics processes are free of charge in terms of license or royalty fees and take into account the industrial (scale-up) and regulatory requirements for the manufacturing of GMP grade material. The services proposed by Sartorius Xpress Biologics are based on 4 technological platforms: – molecular biology for the design of microbial expression systems (E. coli & P. pastoris), – fermentation development with 5L fermenters for production yield optimization and scale-up development and production with 50L fermenter, – downstream process development including extraction, clarification, liquid chromatography, tangential flow filtration…, – quality control (HPLC, spectrophotometry…). The company offers the following services: – project development, experimental design, risk analysis, consultancy, – design and construction of expression systems, – development of fermentation and purification methods, – development of analytical tools, – process scale-up study, – production of biologics (from 100 mg up to 40 g), – process scale-up study. Sartorius Xpress Biologics has extensive experience in the production of plasmid DNA (pDNA) and proposes custom manufacturing of Discovery Grade (DG), Research Grade (RG), High-Quality (HQ), and GMP grade pDNA. The DG grade manufacturing service is based on the production of up to 100 mg of purified pDNA using an optimized shake-flask production combined with an advanced small-scale purification process leading to highly purified pDNA with low endotoxin content (
Samsung Biologics
Samsung Biologics is a fully integrated end-to-end service provider offering development and manufacturing services, all at one site. We provide highly tailored solutions to clients, while meeting the evolving needs of the global healthcare industry. With proven regulatory approvals, Samsung Biologics is a trusted CDMO partner of choice and is uniquely able to provide seamless offerings from cell line development to final aseptic fill/finish for biologics. To maximize our operational efficiency and expand our capabilities in response to growing biomanufacturing demands, Samsung Biologics is constructing a fourth plant, which will further advance the company’s standing as the world’s largest manufacturing facility at a single site—holding a 604KL total capacity upon full completion in mid-2023. Our facilities are all cGMP compliant with bioreactors ranging from small to large scales. We continue to upgrade our capabilities to accommodate our clients by investing in single-use technology and additional aseptic filling capacity. Additionally, Samsung Biologics’ R&D Center in South San Francisco is equipped for high-quality cell line development, and our Sales Office in Ridgefield Park, New Jersey, enables the company to work in closer proximity to clients based in the U.S. and Europe. We are committed to on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions, operational excellence, and proven expertise. Your Trusted CDMO Partner, Samsung Biologics | Samsung Biologics is a fully integrated CDMO partner of choice, providing highly tailored solutions to clients while meeting the evolving needs of the global healthcare industry. With proven regulatory approvals, we provide seamless offerings from cell-line development to final fill/finish at every stage for biopharmaceutical products. Our plants are cGMP compliant with a wide range of bioreactor scales to serve varying client needs and meet growing market demand. We hold a total capacity of 604KL at Bio Campus I, the world’s largest biomanufacturing site, and have announced plans to construct a fifth plant, which will be operational in April 2025. | Samsung Biologics (KRX: 207940.KS) is a global contract development and manufacturing organization (CDMO), offering end-to-end integrated services that range from late discovery to commercial manufacturing. With a combined biomanufacturing capacity of 784kL across five plants, Samsung Biologics leverages its technologies and expertise to advance diverse modalities, including antibody-drug conjugates (ADC), multispecific antibodies, fusion proteins, and mRNA vaccines. With over 5,000 employees, Samsung Biologics operates a global network with facilities and offices in Korea, the U.S., and Japan. Samsung Biologics America facilitates support to clients based in the U.S. and Europe, while a sales office in Japan serves the APAC region. Samsung Biologics continues to invest in new capabilities to maximize operational and quality excellence, ensuring flexibility and agility for clients. The company is committed to the on-time, in-full delivery of high-quality products, as well as making sustainable business decisions for the betterment of society, global health, and the planet. For more information, please visit https://samsungbiologics.com/