List of Contract Manufacturing Companies in Massachusetts - 27

Agenus Inc., a clinical-stage immuno-oncology company, discovers, manufactures, and develops immuno-oncology products in the United States and internationally. The company offers Retrocyte Display, an antibody discovery platform for the identification of fully-human and humanized monoclonal antibodies; and display technologies. It develops vaccine programs, including Prophage vaccine candidate; AutoSynVax, a synthetic neo-antigen; PhosPhoSynVax, a vaccine candidate designed to induce immunity against a class of tumor specific neo-epitopes; and QS-21 Stimulon adjuvant, a saponin-based vaccine adjuvant. The company also develops CTLA-4 and PD-1 antagonists which is in clinical trial phase I for the dose escalation study; AGEN2373, an anti-CD137 monospecific antibody which is in Phase 1 clinical trial; AGEN1223, a novel bispecific antibody designed to deplete regulatory T cells which is in a Phase 1 clinical trial; GS-1423, a tumor microenvironment conditioning anti-CD73/TGFS TRAP bi-functional antibody which is in Phase 1 clinical trial; and TIGIT antibodies. In addition, it engages in the development of INCAGN1876, an anti-GITR monospecific antibody; INCAGN1949, an anti-OX40 monospecific antibody; INCAGN2390, an anti-TIM-3 monospecific antibody; INCAGN2385, an anti-LAG-3 monospecific antibody; and MK-4830, a monospecific antibody targeting ILT4. Agenus Inc. has collaboration agreements with Incyte Corporation, Merck Sharpe & Dohme, and Recepta Biopharma SA.; and collaboration with Gilead Sciences, Inc. to develop immuno-oncology therapies. The company was formerly known as Antigenics Inc. and changed its name to Agenus Inc. in January 2011. Agenus Inc. was founded in 1994 and is headquartered in Lexington, Massachusetts.

Asimov's mission is to advance humanity's ability to design living systems, enabling biotechnologies with outsized societal benefit. The company is developing a synthetic biology platform from cells to software to design and manufacture next-generation therapeutics, including cell & gene therapies, through a combination of products, services, & collaborations. Founded by bioengineers from MIT and Boston University and headquartered in Boston, the company has raised over $200 million.

It is Berkshire Sterile Manufacturing’s (BSM) goal to provide the safest sterile drug products possible for clinical use and small scale requirements. BSM will provide small scale sterile manufacturing services with highest level of sterility assurance and quality achievable through the use of the most modern technologies for sterile manufacturing, stringent quality standards and highly trained employees. BSM will also provide ancillary support to their clients’ drug productions such as analytical method development and validation, stability studies and formulation scale up.

BioSurfaces, based in Ashland, Massachusetts, is a life science company with deep leadership and a diverse team of specialists. The company's proprietary electrospinning technology known as Bio-Spun™ creates product solutions by engineering biology with synthetic cellular matrices for applications ranging from IVRT and delivery of bio-active therapeutics to medical devices and consumer health products. These materials can be made to form a variety of unusual and difficult-to-manufacture shapes while also demonstrating improved biocompatibility over other textile-based materials. The BioSurfaces manufacturing process also allows the incorporation of drugs or other bioactive agents directly into the nanofibers for localized release. BioSurfaces' technology is validated by leading organizations in pharmaceuticals, medical devices, life sciences, and consumer products.

For nearly 30 years, Boston BioProducts (BBP) has been dedicated to providing buffers and solutions for life sciences research, diagnostics, and biomanufacturing. Learn how you can quickly develop your next buffer formulation: https://bostonbioproducts.com/custom-formulations/

BIB is a full service CDMO partner offering cGMP and non-GMP mammalian, microbial, gene therapy and cell therapy services.

Bold and nimble, Boston Oncology is an innovative biogenerics company redefining excellence in the licensing and local development, manufacturing and distribution of US- quality medicines – across therapeutic areas. From our nerve center in Riyadh, we leverage the expertise, daring creativity, and unwavering determination of our international leadership team to provide customers with end-to-end, efficient, single-point-of-contact access to our diverse portfolio of world-class biogenerics. We do this because lives depend on it.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guides us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.

CuriRx, Inc is a certified minority woman owned company with 13,000 sqft, well equipped facility, established in 2012 and located in the Wilmington, MA. With combined experience of over 150 years, we offer high quality development services, in following areas • Analytical Development and testing services o Development, Qualification and Validation o Non-GMP and GMP testing and Stability studies o Product characterization o Particle Characterization • Drug Product Development services o Pre-Formulation and Formulation Development, Lyophilization Cycle Development o Parenteral (IM, IV, SC, IT), Ocular Nanotechnology We have successfully developed over 100 clinical formulations involving biological compounds. Our experience includes developing clinical formulations in both liquid and lyophilized dosage forms. The scientists at CuriRx have proven track record with successes in developing commercial products like Humira & Synagis (high con mAbs), Blincyto (Bispecific) and Gattex (Peptide) etc. • Bulk Drug Substance Development, CHOZN, CHOK1, HEK293, ExpiCHO, E,coli o Cell Line and Clone development o Transient transfection, creating stable pools. o Cell Culture 1Lbioreactors-50 Liter’s bioreactors & Purification o Process characterization

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

FORAY Bioscience is producing forest products without cutting down a single tree. Beyond creating a climate-resilient supply to support a growing demand for wood, FORAY is also developing new materials and products that will help protect and restore natural ecosystems. The company uses biomanufacturing techniques to produce wood products.

Freudenberg Medical is a global partner for the design, development and manufacture of medical devices, components, and minimally invasive product solutions. Our comprehensive technical capabilities range from the design and manufacture of minimally invasive, catheter, and handheld technology to the development and production of medical components utilizing advanced materials and processes. We are an industry leader in the manufacture of high precision silicone and thermoplastic components and tubing as well as metal hypotubes and coating technology. Freudenberg Medical is part of the Freudenberg Group, a global technology group. As an organization, we ensure that every project is supported by our unmatched range of global resources, financial stability, and the flexibility to optimize for business performance. www.FreudenbergMedical.com Explore the possibilities with Freudenberg Medical, please call 877-308-0558 or email info@freudenbergmedical.com

Growth Curve Bio is a company that provides the newest generation of efficient and reliable Bioscreen systems for automated growth curve analysis.

Harvard Bioscience is a global developer, manufacturer and marketer of a broad range of specialized products, primarily apparatus and scientific instruments used to advance life science research at pharmaceutical and biotechnology companies, universities and government laboratories worldwide. We sell our products to thousands of researchers in over 100 countries through our full-line catalog (and various other specialty catalogs), our websites, and through distributors, including GE Healthcare, Thermo Fisher Scientific Inc., and VWR. We have sales and manufacturing operations in the United States, the United Kingdom, Germany, and Spain and sales facilities in France and Canada.

Kudo Biotechnology is a global CDMO, providing world-class, end-to-end mRNA manufacturing solutions, all under one roof. Kudo has state-of the-art clinical GMP manufacturing facilities and labs in Boston, China & Singapore, making pDNA, mRNA and LNP. Kudo Bio differentiates by being a one-stop stop for all your mRNA manufacturing needs, by streamlining the process, removing bottlenecks and ensuring ease in your CMC. Our performance matches and surpasses industry-leading yields & efficiencies across all stages of the process. Our speed of 6.5 months from sequence to GMP mRNA-LNP exceeds industry platinum standards, and our quality is superior to competitors while maintaining full compliance with global regulatory requirements. Kudo Bio has a track record of accomplishing end-to-end GMP manufacturing with products entering the clinic, and successfully completing multiple batches of process validation after international technology transfer. We have an industry-leading manufacturing cGMP facility with capacity to make up to 50 GMP batches annually, with deep technology partnerships enabling access to scale-up expertise & production know-how. Finally a comprehensive quality management system with QA/QC capabilities which meet major regulatory agencies' compliance requirements is paramount to delivering products to customers around the world.

Landmark Bio is a collective endeavor launched by leaders from academia, the life sciences industry, and world-renowned research hospitals to accelerate development and industrialization of next-generation genomic medicine. Inspired by recent advancements in cell and gene therapy, Landmark Bio was established to remove barriers in drug development, create accessible capability, expertise, and solutions, and offer a collaboration platform to advance manufacturing technologies for the new generation of medicines to come. Founding partners include Harvard University, Massachusetts Institute of Technology (MIT), Cytiva, FUJIFILM Diosynth Biotechnologies (FDB), and Alexandria Real Estate Equities, Inc. Other collaborating institutions include Beth Israel Deaconess Medical Center, Boston Children’s Hospital, Mass General Brigham, and the Dana-Farber Cancer Institute. For more information please contact info@landmarkbio.com

MedTherapy is a Boston-based global biotechnology corporation manufacturing cell, gene and immunological therapies for treatment of cancer to make them accessible and affordable for every cancer patient in the world. MedTherapy works in collaboration with Harvard Medical School, Merck, and the 'International Health Organization'​ (IHO) and many leading private and public instutions, organizations and biotechs. Cell, gene and immunological therapies comprise the most sophisticated treatments modern technology has developed. While their success has been deemed a ‘miracle’, however, unfortunately, their cost is exorbitant often running into millions of dollars which is not sustainable for any individual patient, society or country. Therefore, MedTherapy works in collaboration with various organizations- private, public, academia and non-profits in US and globally to develop more streamlined processes, technologies and partnerships to manufacture these sophisticated medical therapies and made affordable for every patient in the world.

For over 50 years, PSI has provided technology solutions and innovative products to our government and commercial customers. Our employee-owners continue to grow the company across a range of markets applying emerging science to important problems. We play an important role in the development and transition of advanced technology from the laboratory to commercial and government use. PSI has a highly interdisciplinary staff with advanced degrees in chemistry, biology, physics and applied physics, electrical, aeronautical, and mechanical engineering, and materials science. We are structured to enable cross-disciplinary collaboration between our scientists and engineers in order to develop solutions to our customers' technical problems. Our extensive laboratory and prototyping facilities as well as low rate production capability enable us to rapidly go from concept to advanced prototype, and then on to manufacturing. We couple this internal capability with our long heritage in field and clinical testing of prototype systems enabling us to gain valuable feedback leading to rapid improvement.

PolyOrg, Inc., founded in 2003, provides comprehensive chemical synthesis services to life science companies and research universities. We help our customers develop new products, improve existing products, and transition their existing products from research to manufacturing. We perform contract research, process development, custom synthesis, and manufacturing for clients in various science industries. Our clients are primarily in the pharmaceutical, biotechnology, specialty chemicals, and diagnostic industries. We employ expert Ph.D. chemists and process technicians skilled in organic, solid phase, medicinal, natural product, and polymer chemistry. For inquiries or quotation requests, email info@polyorginc.com.

Reprieve Cardiovascular, Inc. is developing innovative and groundbreaking therapies that aim to improve the lives of more than 25 million heart failure patients around the world. Reprieve is bringing intelligence to decongestion management to safely accelerate fluid removal for heart failure patients. In 2022, Reprieve initiated the FASTR Trial (pilot study) to compare decongestive therapy administered by the Reprieve Decongestion Management System to Optimal Diuretic Therapy in the treatment of patients diagnosed with acute decompensated heart failure. Reprieve is a privately held medical device company, headquartered in Milford, Massachusetts, USA.

RootPath is a synthetic biology company that elevates the throughput of gene function interrogation by orders of magnitude. Our molecular programming-based DNA fragment assembly technology gives life science researchers, drug developers and synthetic biologists unprecedented access to accurate, long synthetic genes and their functional readouts. We enable biology at scale.

Safi Biotherapeutics is an early stage biotech company developing cell therapies from hematopoietic progenitor sources.

Sunflower Therapeutics is a unique biotechnology start-up focused on dramatically reducing the time and cost to develop and manufacture biologics for patients around the world. With a genetically-optimized host, data-driven process development, and a novel, ‘right-sized’ manufacturing unit, the experienced Sunflower team is creating an efficient, patient-centered, end-to-end drug production platform that we plan to deploy worldwide.

At Terrain Bio, we help RNA therapeutics companies design and build better RNA, faster. Leveraging the latest innovations in protein and RNA design and the deep expertise of its scientific cofounders, we bring unparalleled speed and quality to RNA manufacturing.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Tobin Scientific is a provider of biopharma cold chain logistics, ambient storage, and laboratory relocation services. Founded in 1960 and headquartered in Beverly, Massachusetts, the company serves life sciences institutions, pharmaceutical companies, and research organizations. With a focus on compliance, redundancy, and sustainability, Tobin Scientific has established itself as a trusted partner for handling temperature-sensitive products. The company operates a 100,000-square-foot warehouse in the Boston metro area and has a national presence, offering coast-to-coast transport of live specimens and sensitive materials. Tobin Scientific's services include specialized transport under strict guidelines, GMP-compliant warehousing, and expert laboratory relocation. They also have licensed personnel trained in hazardous material logistics, ensuring the integrity of the chain of custody. Tobin Scientific emphasizes eco-conscious practices with energy-efficient equipment and multi-redundant systems for critical shipments. The company collaborates with biotech firms, academic institutions, and government agencies, and recently expanded its capabilities through the acquisition of BioRepository Resources.

ZSFab dedicates to produce high performance, low-cost, customized medical implants, surgical guides and anatomical models. We are developing unique solutions that integrate our own software tools, advanced modeling and optimization methods, and 3D printing technology. Each of us is born unique, and such uniqueness is imprinted in our DNA and reflected in our finger print, our face, our bone. Such uniqueness requires that when the part is worn, damaged, or aged, the replacement shall be the same. With the help of additive manufacturing, ZSFab is to structure, design, print the best medical implants and assist in the healing process. ZSFab has the goal to provide the solutions for health care, including surgical process. With the products of ZSFab, we will help to ease the burden of the doctors and release our customers of prolonged pain. In ZSFab, we believe: all men are created equal, but shall be treated differently, when it comes to healthcare.