List of Contract Manufacturing Companies in Maryland - 12

AAVnerGene Inc is an innovative company specialized in AAV technologies. It is founded by a group of AAV gene therapy enthusiasts who dream to serve the community, promote and lead the future of gene therapy. Our passion is to solve the bottleneck problems in AAV gene therapy and find more and better cures for all the patients. We believe that hard core technologies are the key to achieve it. With 20 years of frontline gene therapy experience, our team develops novel AAV vectors, methods and strategies that can efficiently produce, deliver and express high quality vectors into specific cells. Our goal is to increase AAV gene therapy efficacy and decrease the cost, making it accessible and affordable to patients. Our highly complex AAV capsid libraries allow us to efficiently select the best AAV capsid for each cell type in a high-throughput manner.

With a 60+ year history as a service provider to the life sciences industry, Advanced BioScience Laboratories (ABL) provides a strong core of product development expertise, GMP manufacturing, and analytical testing capabilities. Founded in 1961 as a biomedical research contractor for the federal government, ABL has made major contributions to the development and evaluation of a wide range of life-saving diagnostics, vaccines, and therapeutics designed to combat the world's most challenging diseases. We partner with our clients to support advancement of their candidate vaccines and therapeutics through preclinical and clinical development. With facilities located in the United States, ABL aims to be a seamless extension of our clients' team – helping them advance today's ideas into tomorrow's medicines. ABL's CDMO service division specializes in the development and manufacturing of GMP cell banks and viral vectors from the bench to Phase I/II clinical trials. We aim to contributes to the success of our clients' ground-breaking innovations, including gene therapies, immunotherapies, viral vaccines, oncolytic viruses, and more. ABL's CDMO services include bulk drug substance production, fill/finish of drug products, process development, assay development and release testing.

With a 60+ year history as a service provider to the life sciences industry, Advanced BioScience Laboratories (ABL) provides a strong core of product development expertise, GMP manufacturing, and analytical testing capabilities. Founded in 1961 as a biomedical research contractor for the federal government, ABL has made major contributions to the development and evaluation of a wide range of life-saving diagnostics, vaccines, and therapeutics designed to combat the world’s most challenging diseases. We partner with our clients to support advancement of their candidate vaccines and therapeutics through preclinical and clinical development. With facilities located in the United States, ABL aims to be a seamless extension of our clients’ team – helping them advance today’s ideas into tomorrow’s medicines. ABL's CDMO service division specializes in the development and manufacturing of GMP cell banks and viral vectors from the bench to Phase I/II clinical trials. We aim to contributes to the success of our clients' ground-breaking innovations, including gene therapies, immunotherapies, viral vaccines, oncolytic viruses, and more. ABL's CDMO services include bulk drug substance production, fill/finish of drug products, process development, assay development and release testing.

BioFactura develops and commercializes biodefense drugs, novel drugs, and high-value biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal choice for bringing these products to market with faster, lower cost, superior-quality manufacture. For over 10 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases.

Elixirgen Scientific is a global leader in regenerative medicine and biotechnology, headquartered in the Science + Technology Park at the Johns Hopkins Medical Campus in Baltimore, MD. Our mission is to advance science and medicine with fast, functional, and scalable induced pluripotent stem cell (iPSC) differentiation products and services. Our state-of-the-art, transcription-factor-based technology allows you to overcome the high cost and inefficiencies associated with lengthy cell differentiation periods. We empower research institutions, pharmaceutical organizations, and biomedical enterprises worldwide, even those with no previous iPSC experience, by increasing access to relevant cells for modeling human biology and accelerating the path to drug discovery and development. This commitment to innovation and efficiency underpins our goal to revolutionize regenerative medicine. We are the partner of choice for supplying high-quality, reliable iPSC-derived cells and kits and conducting customized research services. Connect with Elixirgen Scientific today to discover how we can accelerate your research!

Emergent BioSolutions Inc., a life sciences company, focuses on the provision of specialty products for civilian and military populations that address accidental, deliberate, and naturally occurring public health threats (PHTs). The company's products address PHTs, which include chemical, biological, radiological, nuclear, and explosives; emerging infectious diseases; travel health; and emerging health crises and acute/emergency care. It offers BioThrax, an anthrax vaccine; ACAM2000, a smallpox vaccine; Vaxchora, a cholera vaccine; and Vivotif, a typhoid vaccine. The company also provides NARCAN for the emergency treatment of known or suspected opioid overdose; Reactive Skin Decontamination Lotion Kit, a medical device to remove or neutralize chemical warfare agents from the skin; and Trobigard a combination drug-device auto injector product candidate. In addition, it offers raxibacumab for the treatment and prophylaxis of inhalational anthrax; Anthrasil to treat inhalational anthrax; Botulism Antitoxin Heptavalent for treating botulinum disease; vaccinia immune globulin intravenous that addresses complications from smallpox vaccination; CHIKUNGUNYA, a chikungunya virus-like particle vaccine; and ADENOVIRUS 4/7. Further, the company offers other discovery and preclinical product candidates addressing PHTs, including viral hemorrhagic fevers caused by Ebola, Marburg, Sudan, and Lassa viruses; diarrheal disease caused by Shigella; and heat-labile toxin producing enterotoxigenic Escherichia coli, etc. Additionally, it offers FLU-IGIV to treat Influenza A infection; and ZIKV-IG, a prophylaxis for Zika infections, as well as contract development and manufacturing services to pharma and biotech industries, and government agencies/non-governmental organizations. The company has collaboration agreements with Novavax Inc.; and Johnson & Johnson. Emergent BioSolutions Inc. was founded in 1998 and is headquartered in Gaithersburg, Maryland.

Kemp Proteins, LLC (formerly Kempbio) is a privately-owned, USA-based contract research and manufacturing organization located in Frederick, MD. Kemp Proteins is a premier provider of customized solutions for protein-related challenges. We are "Protein Problem-Solvers" focused on delivering best-in-class gene-to-protein services that optimize productivity and mitigate risk for innovators across the life sciences. The company has over two decades of experience in production of proteins and antibodies for use in basic research, diagnostics and drug development at the pre-clinical stage. Core expertise consists of gene-to-protein expression in mammalian, insect, and E. coli, hybridoma and stable cell-line development, analytical protein characterization, and Upstream/ Downstream process discovery/ optimization. Kemp Proteins' Process Discovery Services transition early therapeutic discovery programs to the biomanufacturing phase. Our teams identify key developability markers early in the discovery process while keeping scale and safety in mind. We use Process Analytical Tools in the initial discovery phase to identify the Critical Process Parameters required to derive Upstream and Downstream Processes that ensure Critical Quality Attributes are met. Once unit operations are defined for scale, we generate engineering and tox-material suitable for reference and NHP studies. The final processes are captured in Manufacturing Batch Records enabling seamless transitions to GMP facilities. Kemp Proteins has experience expressing and purifying a wide range of proteins from antibodies to multi-protein complexes and virus-like particles. The company operates under an ISO9001- and ISO13485-certified Quality Management System and the animal care and use program is AAALAC-accredited.

𝘐𝘮𝘱𝘳𝘰𝘷𝘪𝘯𝘨 𝘏𝘦𝘢𝘭𝘵𝘩 𝘛𝘩𝘳𝘰𝘶𝘨𝘩 𝘐𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘷𝘦 𝘋𝘪𝘢𝘨𝘯𝘰𝘴𝘵𝘪𝘤𝘴. MaximBio's comprehensive in-house capabilities provide you a world-class experience and confidence in our ability to keep costs down and deliver your products in time. At MaximBio, our team of dedicated professionals with over 25 years of expertise work to create a custom-fit, full service program in state-of-the-art facilities to meet all your needs and specifications: • FDA cGMP Registered for manufacture and distribution of medical devices • Compliant with 21 CFR Part 820 for medical devices • ISO 13485:2016 Certified for manufacturing and packaging of medical devices

Catalent Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. Since becoming a publicly traded company in 2014, we have grown to become a community of approximately 19,000+ workers who support over 7,000 products for over 1,000 customers around the world. We share a common goal: to put patients first and help people around the world live better and healthier lives. Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. We have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging results. more products. better treatments. reliably supplied.™ Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech, and healthcare companies, will help bring life-enhancing products to life. Grow with us. Be challenged. Make a personal impact. Visit https://careers.catalent.com/us/en to explore career opportunities

Quality Biological (QBI) provides quality solutions for life science research and bioproduction applications. We specialize in producing custom and standard cell culture and molecular biology reagents, buffers, and liquid solutions and providing supporting services. At QBI, we help our clients achieve their application goals faster. We do this by being flexible and nimble, providing a level of personalized service our clients rely on. QBI is home to a fully-equipped, ISO 9001:2015 certified manufacturing facility. At the base of every product is water that exceeds industry specifications. This enables us to provide you with solutions of superior quality and value. We have your solution...whether you need a few liters of medium, buffer or a custom solution for research, dozens of liters of one single lot for process and method validation, or hundreds of liters for commercialization. We work with you to address your specific needs and requirements. Contact us today to discuss your specific media and buffer needs.

Located in Frederick, MD, XpressBio is a small biotechnology company that manufactures and markets molecular and immunological products and services to the bioscience research community worldwide. Because XpressBio scientific officers are comprised of an elite group of pioneers in immunology and molecular biology, our customers are some of the world's leading pharmaceutical, biotechnology, government, and academic organizations. We are committed to satisfying our customers' expectations by providing high-quality products and services matched by superb customer service. Our research capabilities and extensive experience allow XpressBio to continuously expand its product portfolio by responding to the needs of clients for a personalized solution. Partnering with clients in this manner allows us to customize products for client needs while simultaneously expanding our product offering. Together, we can conquer manufacturing and product development challenges in a rapidly evolving environment.