Company Category: Regulatory / CMC Documentation

Phlow

Phlow is a U.S.-based, Certified B Corporation™ leveraging advanced manufacturing processes to re-imagine the domestic production of key starting materials (KSM), active pharmaceutical ingredients (API), and finished drug products that are critical to U.S. healthcare. Focused on impact, Phlow partners with children’s hospitals, private industry, and the U.S. government to increase access to affordable, high-quality life-changing medicines through advanced manufacturing processes that are fully integrated, comprehensive, and better for the environment. Utilizing its advanced R&D labs and best-in-class, automated API cGMP facilities ranging from kilo to metric ton scales, Phlow provides customized contract development and manufacturing services for small molecule APIs to pharmaceutical and biotech companies. Phlow measures its success by its ability to drive down costs and waste, improve quality and yield, and offer a more environmentally friendly approach to manufacturing medicines that lead to healthy and resilient communities. For more, visit www.phlow-usa.com. | Phlow, a B Corporation, helps brilliant minds bring medicines to life through advanced development and manufacturing in America. Focused on innovations in drug substance development, Phlow supports government and private industry customers with scientific expertise, world-class manufacturing, and tech-enabled processes that move the industry toward a new standard as we create the future of how medicines are made. For more information, visit phlow-usa.com.

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PAN-Biotech GmbH

PAN-Biotech is your trusted partner for OEM and CMO solutions in the biotech industry. With over 30 years of experience, we offer high-quality cell culture media, sera, and custom manufacturing sterile liquid solutions. Benefit from our expertise and expand your business in Europe with a reliable partner by your side. • Manufacturing (OEM, CMO, CDMO) • Upstream / Downstream • R&D for Cell Culture • Tailored Logistic Solutions Products & Services Our core strength is our flexibility, which enables us to provide customized solutions to partners in research and industry. This includes state-of-the-art cell culture products for research and preclinical applications, all manufactured according to ISO 13485. For clinical applications, we facilitate a seamless transition from RUO (Research Use Only) to EU GMP Annex 1, thereby supporting easy access to commercialization. Gateway to Europe with PAN-Biotech At PAN-Biotech, we understand the challenges when setting foot on a new continent. We are here to assist you every step of the way. From manufacturing and product storage to delivering your products to new customers, we provide comprehensive support to help you achieve your goals. | PAN-Biotech offers high-quality cell culture media, sera, and custom manufacturing sterile liquid solutions. This includes state-of-the-art cell culture products for research and preclinical applications, all manufactured according to ISO 13485. For clinical and industrial applications, we offer GMP grade products in accordance with GMP EU Annex 1.

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PackGene Biotech

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution. | PackGene Biotech excels as a leader in Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) services, focusing on adeno-associated virus (AAV), mRNA, plasmid DNA, and lentiviral vector (LVV) solutions. Catering to early-stage drug discovery, preclinical development, and cell and gene therapy trials, we offer cost-effective, reliable, and scalable production. Our π-Alpha 293 AAV High-yield Platform marks a significant leap in AAV production, increasing yields by up to tenfold and supporting large-scale AAV batches up to 1E+17vg, meeting most commercial and clinical project needs. We also provide scalable, custom plasmid DNA solutions for various project sizes, encompassing end-to-end design, production, and manufacturing. Our GMP plasmid Manufacturing Platform can accommodate production scales from 5L to 200L. Our services extend to comprehensive process development, analytical development, and cell banking support for AAV, LVV, and plasmid projects. Additionally, we specialize in mRNA and LNP solutions, supporting the full spectrum of drug and vaccine development from research to GMP production. Committed to fostering innovation in biotechnology and healthcare, PackGene offers advanced solutions tailored to the evolving demands of the industry.

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OXB (formerly Oxford Biomedica)

OXB, formerly Oxford Biomedica, is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, OXB has over 30 years of experience in viral vectors; the driving force behind the majority of cell and gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), adenovirus and other viral vector types. OXB’s world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines. OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, Bedford MA, and Durham NC, US. Learn more at www.oxb.com and follow us on LinkedIn and YouTube.

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OranssiBio Ltd.

Oranssibio Ltd. | OranssiBio is a premier Contract Development and Manufacturing Organization (CDMO) strategically headquartered in Shanghai’s Free Trade Zone, specializing in advanced cell and gene therapies. We partner with biotech innovators and research institutions worldwide, delivering comprehensive, end-to-end solutions from early-stage development to clinical supply manufacturing and regulatory-compliant release. Our state-of-the-art, plug-and-play technology platforms support a diverse range of modalities, including: • Plasmid DNA • Lentivirus & Adeno-Associated Virus (AAV) • mRNA Therapeutics • Cell Therapies: CAR-T, TILs, NKs, iPSCs, and MSCs With a focus on quality, speed, and cost efficiency, OranssiBio accelerates the translation of groundbreaking therapies from bench to bedside, empowering our partners to bring life-changing treatments to patients faster and more effectively.

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OneSource Specialty Pharma

OneSource is a pure-play specialty pharmaceutical CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five state-of-the-art manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,400 professionals. OneSource with its development capabilities, industry leading manufacturing capacities, and strong compliance track record, has won trust of global pharmaceutical companies seeking efficient, end-to-end solutions. For more information, please visit www.onesourcecdmo.com.

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Novotech

Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations. Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years.

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NorthX Biologics

We offer services and support in the development and manufacturing of biologics used in vaccines, gene therapy and other advanced applications. Let’s journey together. | Nestled in Sweden’s life sciences heartland, NorthX Biologics has been at the forefront of biologics manufacturing and process development since 1992. Our rich heritage in Good Manufacturing Practice (GMP) is not just a testament to our enduring commitment to quality but also to the trust that the biotech community has placed in us for nearly three decades. Our expertise spans a comprehensive spectrum of biologics, including plasmids, proteins, mRNA, viral vectors cell therapy, and an array of other advanced therapeutic entities. It is our relentless pursuit of excellence and innovation that led to our recognition in 2021 as a national innovation hub for advanced therapeutics and vaccines by the Swedish Government, a milestone that underscores our role in shaping the future of healthcare. We are more than a CDMO; we are pioneers and partners in the truest sense. At NorthX Biologics, we believe in embarking on a collaborative journey with our clients, navigating the complexities of biologics and growing along the way. Let’s journey together to turn visionary science into life-changing treatments. Visit us to learn more at nxbio.com | Nestled in Sweden’s life sciences heartland, NorthX Biologics has been at the forefront of biologics manufacturing and process development since 1992. Our rich heritage in Good Manufacturing Practice (GMP) is not just a testament to our enduring commitment to quality but also to the trust that the biotech community has placed in us for nearly three decades. Our expertise spans a comprehensive spectrum of biologics, including plasmids, proteins, mRNA, viral vectors cell therapy, and an array of other advanced therapeutic entities. It is our relentless pursuit of excellence and innovation that led to our recognition in 2021 as a national innovation hub for advanced therapeutics and vaccines by the Swedish Government, a milestone that underscores our role in shaping the future of healthcare. We are more than a CDMO; we are pioneers and partners in the truest sense. At NorthX Biologics, we believe in embarking on a collaborative journey with our clients, navigating the complexities of biologics and growing along the way. Let’s journey together to turn visionary science into life-changing treatments.

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NIPPON SHOKUBAI

Nippon Shokubai provides contract manufacturing (CDMO) services for oligonucleotide and peptide active pharmaceutical ingredients (APIs), often referred to as middle molecules. With our advanced, GMP-compliant facilities, we support every stage—from discovery through clinical trials to post-marketing. We also offer comprehensive solutions for manufacturing process development and analytical method development. We are also actively advancing drug delivery systems (DDS) that are critical for middle molecules. This includes developing substances for targeted delivery to disease sites and new biocompatible polymers for DDS, helping to optimize therapeutic outcomes. Capabilities ・Contract manufacturing (CDMO) of oligonucleotide APIs ・Contract manufacturing (CDMO) of peptide APIs ・Contract manufacturing (CDMO) of middle molecule APIs ・Process development ・Analytical development ・Technical transfer for manufacturing ・New biocompatible polymers (DDS and others) ・siRNA-delivery peptides ・Heteroduplex oligonucleotides | Using our own technology, we at NIPPON SHOKUBAI manufacture ethylene oxide, acrylic acids, catalysts, superabsorbent polymers and so on. We will continue to launch new products in ICT, Life Science and Energy & Environment fields and perpetuate corporate mission of “TechnoAmenity: Providing prosperity and comfort to people and society, with our unique technology”.

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