BioDuro, an Advent International portfolio company is a trusted, leading contract research development, and manufacturing organization (CRDMO) for 30 years. We provide our biotech and pharmaceutical partners with fully integrated services to support their efforts from target identification through to commercial drug product manufacturing. The company is based in the US with operations in China, totaling 2,000+ scientists and 7 global sites across 6 cities. Core expertise includes small and large molecule discovery, development and scale-up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The one-stop-shop operation helps biotech and pharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes. We adhere to one global highest standard of compliance and business operation code. Science-driven, customer-oriented, flexible, people-focused culture enables us to provide top-tier integrated, fast and flexible tailored services to our customers to meet their unique needs and accelerate our development timeline. For more information about BioDuro, please visit our website at www.bioduro-sundia.com | BioDuro, an Advent portfolio company, is a CRDMO with a 30-year proven track record. Headquartered in Irvine, California, BioDuro employs more than 2,000 scientists with deep expertise in small- and large-molecule discovery, development, and manufacturing. We provide fully integrated drug discovery services spanning chemistry, biology, and pharmacokinetics (DMPK), along with comprehensive IND-enabling capabilities, including both drug substance and drug product development.
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.
Avid Bioservices, Inc.
Avid Bioservices (NASDAQ: CDMO) is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology, biopharmaceutical, and cell & gene therapy industries. With over 30 years of experience producing biologics, Avid’s services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including cell line development, upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization. www.avidbio.comwww.avidbio.com | Avid Bioservices, a dedicated biologics CDMO, is transforming the CDMO experience. From concept to market, we are your advocate. We have more than 30 years of unrivaled expertise manufacturing biologics and a leadership team with a 10-year average operational leadership tenure. Our world-class mammalian protein facilities are located in Orange County, CA. We’ve produced more than 250 commercial batches, and 5 commercial products marketed in 90+ countries. We maintain the highest level of compliance with a dedication to continuously improving our quality systems and manufacturing processes. For more than 10 years, we’ve maintained a flawless quality track record which we’re committed to uphold. From early-stage to late-stage, concept to market, every part of our process is personalized. We’re your advocates, your trusted experts, your true partners. For more information, visit AvidBio.com. | Avid Bioservices, a dedicated biologics CDMO, is transforming the CDMO experience. From concept to market, we are your advocate. We have more than 30 years of unrivaled expertise manufacturing biologics and a leadership team with a 10-year average operational leadership tenure. Our world-class mammalian protein facilities are located in Orange County, CA. We’ve produced more than 250 commercial batches, and 5 commercial products marketed in 90+ countries. We maintain the highest level of compliance with a dedication to continuously improving our quality systems and manufacturing processes. For more than 10 years, we’ve maintained a flawless quality track record which we’re committed to uphold. From early-stage to late-stage, concept to market, every part of our process is personalized. We’re your advocates, your trusted experts, your true partners.
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.
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.
ARx
ARx leverages over 60 years of expertise in film and adhesive polymer science to develop transdermal, oral, buccal, and sublingual thin films. These films enhance drug release, absorption, and bioavailability, advance pharmacokinetics, and improve patient safety and experience. A pioneer in novel dosing strategies, ARx partners closely with clients to push the boundaries of drug delivery, offering end-to-end solutions from feasibility through FDA-registered manufacturing. With demonstrated success in commercializing branded and generic drug products and by setting higher standards for quality, safety, and efficacy, ARx continues to expand therapeutic potential and redefine what’s possible in modern medicine.
ARCALIS
ARCALIS leads the world as the most advanced CDMO for mRNA vaccines and therapeutics. ARCALIS is a contract development and manufacturing organization (“CDMO”) for messenger RNA (mRNA) vaccines and therapeutics. The company was jointly established by Axcelead, Inc., the first drug discovery platform company in Japan, and Arcturus Therapeutics, a US-based, global, late-stage clinical mRNA medicines company. mRNA is a new therapeutic and vaccine modality that was only recently commercialized in the wake of the Coronavirus infection, but the challenge toward practical application has been ongoing since the 1990s. Research and development of mRNA have begun targeting not only infectious diseases, but also therapeutics and vaccines for various applications, such as rare diseases, cancer, regenerative medicine, and genome editing.The company provides drug discovery support, CMC development, and manufacturing support services for mRNA therapeutics and vaccines to pharmaceutical and biotech companies. These services are backed by expertise accumulated in Arcturus in the fields of manufacturing technologies.
Andelyn Biosciences
Our Vision: Pioneering Solutions that turn Hope into Reality Our Mission: Accelerating the development and manufacturing of innovative therapies to bring more treatments to more patients Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions that turn hope into reality as a cell and gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. Having 20+ years of experience with viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting/characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 400+ cGMP clinical batches, Andelyn provides research and tox grade plasmids with an additional offering of GMP plasmid manufacturing, full quality system/regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility will expand capacity across 8+ production suites for customization of new programs and tech transferred programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Gene and cell therapy, AAV viral vector manufacturing, Plasmid Manufacturing, Lentiviral vector Manufacturing, Commercial Manufacturing, CDMO, analytical method development, GMP, fill finish, QC/QA release testing, Process Characterization, Regulatory Affairs, Licensing Andelyn Biosciences is a pioneering cell and gene therapy organization born out of Nationwide Children’s Hospital, where the first FDA-approved systemic gene therapy was discovered. See all our Press Releases at: https://www.andelynbio.com/media-center | Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions for Turning Hope into Reality (TM) as a gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. With 20+ years of experience in viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting and characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 450+ cGMP sublots, Andelyn provides research, tox, and GMP grade plasmids Andelyn also has full quality and regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility offers capacity across 16 production suites for customization of new programs as well as tech transfer programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Andelyn Biosciences is a pioneering gene therapy CDMO born out of Nationwide Children’s Hospital, where the first FDA-approved systemic gene therapy was discovered. | Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high quality products by developing and manufacturing processes on its configurable, data-driven AAV CuratorTM Platform, or tech transferring in an established client program. Capabilities include cGMP manufacturing for suspension processes up to a 2,000-liter and adherent processes. A rigorous quality system, regulatory support, and supply chain vertical integration further support clients in bringing their critical therapies to market. For more information, visit andelynbio.com. For Andelyn media inquiries, please contact: media@andelynbiosciences.com