Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing and packaging of complex oral solid dose, liquid, and semi-solid pharmaceutical Rx and OTC products for clinical and commercial uses. From cell-line development and formulation to analytical services and clinical cGMP manufacturing, Bora now provides tailored development and manufacturing services to biologics developers end-to-end. | Bora Pharmaceuticals is a premier global contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, and semi-solid pharmaceutical products for clinical and commercial uses. From cell-line development and formulation to analytical services and clinical cGMP manufacturing, Bora provides tailored development and manufacturing services to biologics developers.
Boehringer Ingelheim Biopharmaceuticals GmbH
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Boehringer Ingelheim BioXcellence™ creates solutions with its partners to reliably supply innovative therapies. One of the world’s largest manufacturers of biopharmaceuticals and an industry pioneer with in-depth experience, Boehringer Ingelheim BioXcellence™ so far has supplied more than 40 commercial products through its global network. | Boehringer Ingelheim is a leading research-driven biopharmaceutical company and creates value through innovation in areas of high unmet medical need. As one of the world’s largest manufacturers for biopharmaceuticals with in-depth experience in this field, the company is an industry pioneer and collaborates with top 20 pharma companies and innovative biotechs. Boehringer Ingelheim BioXcellence™ reliably supplies innovative therapies that transform lives, today and for generations to come. We create solutions with our partners, building on our can-do attitude to improve patient health. Our business is empowered by more than 5,000 dedicated and well-trained employees in development, quality and manufacturing and has access to a global manufacturing network providing the entire production chain from DNA to Aseptic Filling. Our track records, both in commercial and clinical supply speak for themselves – since we started offering contract manufacturing in 1995, we have successfully brought 45 biologics to the market and have transferred and optimized more than 150 development and manufacturing projects at all stages from our customers to our facilities, as well as within our network. While collaborating with our partners we never lose sight of the patients that depend on biopharmaceutical therapies. We offer capabilities to complement your expertise, so together we can deliver better therapies. | As one of the world’s largest manufacturers of biopharmaceuticals, we leverage our in-depth industry experience for collaborating with top pharma and biotech companies. Our contract manufacturing business Boehringer Ingelheim BioXcellence™ is built on profound experience in key technologies – mammalian and microbial derived biopharmaceuticals – and supported by a global manufacturing network ranging from US via Europe to Asia that handles the entire production chain, from DNA to aseptic filling. Our track record in commercial and clinical supply is impressive – since initiating contract manufacturing in 1998, we’ve successfully brought 48 biologics to market. Furthermore, we transferred and optimized over 150 development and manufacturing projects focusing on late stage and commercial supply. We collaborate with partners worldwide, offering capabilities that complement their expertise. Together we turn biologic innovation into commercial success. Boehringer Ingelheim BioXcellence™ is always open to partner on contract manufacturing needs concerning your business. Contact us via www.BioXcellence.com | BioXcellence Manufacturing – Tailored Capacities. Reliable Supply. Your Success, Our Commitment. Boehringer Ingelheim BioXcellence™ is one of the leading biopharmaceutical contract manufacturers — a reliable partner that accompanies customers throughout the life cycle of their products. We provide E2E biopharmaceutical manufacturing based on mammalian cell culture and microbial fermentation, streamlining your product’s lifecycle. We have extensive experience with a variety of different host cells, producing a broad range of molecules in accordance with cGMP manufacturing guidelines and covering all stages of development, including aseptic filling. Our focus is on creating value for our customers through robust processes, optimal preparation for launch, and global clinical and commercial supplies of high-quality biopharmaceuticals. With over 40 years of biotechnology experience and a team of dedicated and highly trained employees, we have helped our customers bring more than 45 biopharmaceutical medicines to the market. Our network of manufacturing facilities spans the globe, from Fremont, California in the United States to Biberach in Germany, Vienna in Austria, and Shanghai in China. With around 460 kL for mammalian cell culture and 12 kL for microbial fermentation in fully licensed multiproduct facilities we are your right partner for high-quality global supplies of biopharmaceuticals to patients. Let’s build a future together based on our history. We have capabilities to complement your expertise and are committed to turning your biologic innovation into commercial reality.
Bionova Scientific
Based in Fremont, California, Bionova Scientific is a rapidly growing biologics CDMO offering world-class services built on a foundation of strong process development and analytical science. Our team shares decades of experience in late stage and commercial launch projects, specializing in mammalian cell culture production of mAbs, bispecifics, fusion proteins and other recombinant proteins. We operate a brand-new commercial-ready GMP biologics manufacturing facility to provide clinical and commercial production for clients and recently initiated an expansion program that will quadruple our GMP manufacturing capacity. We are currently booking slots for 2023 and beyond. Our upstream PD group, with more than 60 benchtop bioreactors, offers capabilities typically found in CDMOs five times our size. | Bionova Scientific is an Asahi Kasei company based in Fremont, California. Bionova Scientific is a full-service biologics CDMO offering world-class services built on a foundation of strong process development, cell line development and analytical science. Our team shares decades of experience in late stage and commercial launch projects, specializing in mammalian cell culture production of mAbs, bispecifics, fusion proteins and other recombinant proteins. We operate a brand-new commercial-ready GMP biologics manufacturing facility to provide clinical and commercial production for clients and recently initiated an expansion program that will quadruple our GMP manufacturing capacity. Our upstream PD group, with more than 60 benchtop bioreactors, as well as the ambr15 and ambr250 platforms offering capabilities typically found in CDMOs five times our size. | Bionova Scientific is a flexible, fast-moving CDMO focused on recombinant protein therapeutics and plasmid DNA. With a strong foundation in cell line development, process development and analytical sciences, we operate a brand-new commercial-ready GMP biologics manufacturing facility to provide clinical and commercial production for clients (with additional expansion underway). Our team shares decades of experience in late stage and commercial launch projects, specializing in mammalian cell culture production of complex recombinant proteins, including mAbs, multispecifics, and fusion proteins. Bionova Scientific is an Asahi Kasei company. | Bionova Scientific is a bespoke CDMO providing end-to-end development and GMP manufacturing services for recombinant proteins and plasmid DNA. We support biotherapeutic programs at any stage, from cell line development through commercial-ready manufacturing. Protein operations are based in Fremont, California, with a dedicated plasmid DNA facility in Houston, Texas offering plasmid design through GMP production. Founded in 2014 and acquired by Asahi Kasei in 2022, Bionova combines CDMO agility with the global resources and financial strength of a leading bioprocessing organization.
BioConnection
BioConnection is a GMP contract manufacturer for the production of sterile drug products in vials or syringes. Our state-of-the art GMP manufacturing facility in Oss, The Netherlands is EMA and US-FDA certified and we have more than 15 years of experience. We can handle liquid products (including suspensions) and freeze dried products in batch sizes ranging from a few hundred vials per batch for personalized medicine purposes up to 150,000 vials per batch for commercial productions. We offer complete drug product service packages including drug product development, filling and freeze drying, technology transfers, scale-up, validation programs, analytical support, stability studies, regulatory dossier support, label & pack (incl. serialization) and final GMP release. | BioConnection is a CDMO for the development and manufacturing of injectable (bio)pharmaceutical products (aseptic). Our state-of-the art GMP manufacturing facility in The Netherlands is EMA and US-FDA certified. We have over 18 years of experience and can handle liquid products (incl. suspensions) and freeze-dried products in batch sizes ranging from a few hundred vials (e.g personalized medicine) up to 150,000 vials per batch for clinical or commercial productions. We offer complete drug product (DP) packages including DP development, freeze-drying, technology transfers, scale-up, validation programs, analytical support, stability studies, regulatory, label & pack (incl. serialization) and final GMP release. | BioConnection fulfills the needs of innovative and generic (bio)pharmaceutical companies by offering flexible state-of-the-art development and GMP-compliant manufacturing services for sterile drug products, both commercial and clinical. We are an experienced and reliable partner for developing and aseptically filling and finishing your (bio)pharmaceutical products. At BioConnection, we support the entire drug life cycle, from producing materials for toxicology studies to clinical material manufacturing (Phase I-III) and final market production (up to 500 L). We excel in smooth project transitions, including internal technical transfers, scale-ups, and efficient preparation for Process Performance Qualification (PPQ) campaigns before market launch. We believe that every client is unique, and every project deserves personalized attention and a tailor-made solution. What sets us apart is our commitment to collaboration and flexibility throughout the process all within the framework of the EMA and FDA rules and regulations. | We are a CDMO focused on filling, finishing, and lyophilizing injectable (bio)pharmaceutical products. We operate from our US-FDA and EMA-approved production site in Oss, the Netherlands. We can support the entire drug life cycle; from producing materials for toxicology studies to clinical material manufacturing (Phase I-III) as well as efficient preparation for PPQ campaigns and final market production using two automated filling lines. We also provide specialized small-scale (hand fill) services for personalized medicines, ensuring precision and flexibility. We have the means, the motivation & expertise and infrastructure to bring your invention from the lab bench to the clinic and to the market. We are an experienced and reliable partner and we believe that every client is unique and important and therefore deserves personalized attention through tailor-made solutions. What sets us apart is our commitment to collaboration and flexibility throughout the process, all within the framework of the EMA and FDA rules and regulations. In addition, we offer a broad range of support services such as process and formulation development, lyo-cycle development and/ or optimization, analytical development & validation, technical transfer, scale-up, process validation, stability studies, label & pack (including serialization), and final batch certification for release to clinic or market.
BiBo Biopharma Inc.
BiBo Biopharma Engineering Co. LTD. (BiBo Pharma) is a Contract Development and Manufacturing Organization (CDMO) focus on biologics. We are one of the few organizations in the world with comprehensive experience of construction and operation experience of large-scale biologics production lines, and committed to setting up new CDMO industry standards with our world-leading PanFlex® -Engineering capacity and integrated management system. We offer full-spectrum and one-stop-shop services from R&D to commercial production for multi-platforms, including microbial fermentation, mammalian cell culture, and gene therapy. BiBo’s 30,000L large-scale manufacturing capability, which is the first in China and the 2nd in the world, can provide our client with state-of-the-art service for commercial production. | BiBo Pharma is a full spectrum CDMO covering the entire CMC lifecycle of biologics. BIB has multiple technology platforms, including microbial fermentation, mammalian cell culture, ADC & GMP facility engineering service. Empowered by PanFlex®-Engineering, our specialist team innovated the world’s first and largest 50,000L and 30,000 L stainless steel ultra-large bioreactor for mammalian cell culture production, and 50,000L and 30,000L high cooling capacity fermenters enabling ultra-high-cell-density fermentation. We have bioreactors and fermenters ranging from 50L to 50,000L and can provide high quality, on time drug supply for GLP tox studies through clinical trials and commercial supply. BiBo’s core team members come from world-leading companies in the US, Europe, and China. We have accomplished over 100 biologics projects, including over 30 in clinical and commercial stages. Our CMC service package includes cell line and strain development, process development, analytical development, formulation development, toxicological and GMP production of drug substance and drug product, process characterization, and large-scale production. We are the world leader in the fourth wave of biomanufacturing. Not only have we established the world’s first and largest 50,000L ultra-large mammalian production line, but it has also achieved a 100% success rate on all scale-up projects by applying our innovative “success on the first time” system.
August Bioservices
August Bioservices is a Contract Development and Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. August Bio offers a full range of pharmaceutical contract development and manufacturing services to pharmaceutical and biotech clients. We focus on sterile injectables, highly-complex formulations, poorly soluble & highly viscous compounds, Uncommon container sizes & fill volumes and offer aseptic and non-aseptic terminally sterilized filling of vials, syringes and flexible IV bags.
Asymchem
Founded in 1999, Asymchem is a global integrated Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing for leading pharmaceutical and biotech companies. Our mission is to drive smarter, greener and more cost-effective manufacturing to support clinical research and commercialization. Asymchem currently operates eight manufacturing facilities offering solutions ranging from early clinical stage to commercial stage, including R&D, cGMP production of advanced intermediates, APIs, formulations and clinical research services. Our scientists excel in the creation and manufacture of enzymes for use in bio-catalysis, the development of practical continuous flow technologies for commercialization, and innovative research and process development from preclinical research to commercialization for both non-GMP or GMP products. Our work has frequently won us “most valuable partner” and “strategic partner” recognition from major pharma and leading biotech companies. For more information, please visit www.asymchem.com. | Asymchem is a leading global CDMO known for its integrated offerings throughout the entire drug development lifecycle. From early-stage research to commercialization, we provide a tailored suite of services that cater to the specific needs of each project. We are committed to embracing cutting-edge technologies that not only enhance efficiency and safety but also prioritize sustainability in the development and manufacturing process. This translates to smarter, greener, and more cost-effective solutions for our clients, ultimately speeding up the delivery of life-saving medications to patients. | Asymchem (Stock Code: 002821.SZ/6821.HK), a global CDMO leader, has provided one-stop pharmaceutical solutions for over 25 years. With a strong foundation in small molecule services, it has advanced capabilities in TIDES, biologics, drug products, clinical research, synthetic biology, and technology transfer. Supported by over 9,000 professionals—45% in R&D—and facilities in China, the U.S., the U.K., and beyond, Asymchem adheres to top-tier cGMP and EHS standards. Trusted by global pharma and biotech leaders, Asymchem delivers high-quality, cost-effective services, reducing time-to-market for therapies and providing client-centric solutions to meet the diverse needs of global drug development.
Ascendia Pharmaceutical Solutions
Ascendia Pharmaceutical Solutions specializes in complex formulation development and manufacturing of pharmaceutical and biologic products using a suite of novel formulation technologies. We provide formulation, analytical, and manufacturing services to pharmaceutical companies, working collaboratively to provide innovative solutions to challenging drug delivery problems and to create advanced medicines. CREATING FORMULATIONS FOR CHALLENGING MOLECULES Ascendia’s expertise involves finding the most effective method of drug delivery for poorly soluble and/or bioavailable molecules. Our comprehensive range of capabilities enables clients to optimize their drug product formulation prior to initiating expensive clinical development. Ascendia provides practical, customized formulation solutions that enable rapid advancement of compounds from discovery to clinical testing. We create trial formulations suitable for PK and tox studies using our nano-emulsion, amorphous solid dispersion, controlled release, LNP and other nanoparticle engineering approaches. We conduct preformulation testing, formulation approach comparisons, dosage form design, and formulation optimization. By working with Ascendia, our clients can quickly determine the feasibility of multiple technical approaches in parallel, thus improving the probability of formulation success and reducing the time required to make critical early-stage formulation decisions. cGMP MANUFACTURING Following formulation selection and optimization, Ascendia can quickly transition a development program to cGMP manufacturing of first-in-man clinical materials. With both aseptic and non-aseptic manufacturing suites in its New Jersey (USA) facility, the company can handle various dosage forms, including those for oral, topical or parenteral administration. Ascendia offers its manufacturing services to third parties that need a CDMO partner for their formulations advancing from preclinical to clinical stages of development. LIFE-CYCLE MANAGEMENT AND 505(b)(2) PRODUCT DEVELOPMENT Ascendia is dedicated to the solubility, bioavailability and stability enhancement of difficult-to-formulate compounds. Our proprietary product development programs focus on creating novel specialty pharmaceutical products that are improved versions of existing medicines. We develop oral, topical and injectable products for clients via the 505(b)(2) NDA pathway, as well providing formulation development and manufacturing for complex generic (ANDA) products.