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Gene Therapy Services

Gene Therapy Services
Product Description

Our gene therapy process development and manufacturing capabilities are designed to confidently and rapidly progress your products from gene to market through development of robust and reproducible cGMP practices.

FUJIFILM Diosynth Biotechnologies

  • US
  • 2021
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Contract Service

FUJIFILM Diosynth Biotechnologies

  • US
  • 2021
    On CPHI since
  • 1000 - 4999
    Employees
Company types
Contract Service

More Products from FUJIFILM Diosynth Biotechnologies (5)

  • A CDMO PARTNER FOR LIFE

    Product A CDMO PARTNER FOR LIFE

    FUJIFILM Diosynth Biotechnologies is an industry-leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting the biopharmaceutical industry in the development and production of biologics, vaccines and cell and gene therapies. Our focus is to combine technical leadership in process d...
  • Cell Culture Services

    Product Cell Culture Services

    FUJIFILM Diosynth Biotechnologies is a leading provider of cell culture services for biologics, advancing anddelivering life changing therapies. We offer complete solutions for cell line development, process development, late phase activities, clinical and commercial manufacturing of a wide variety of biop...
  • Drug Product & Finished Goods

    Product Drug Product & Finished Goods

    End-to-endservices designedfor patient safetyand centricity while offering contracting convenience, cos tefficiencies and time savings. Our globally integrated drugproduct (DP) and finished goods (FG) services offer agileand flexible solutions for clinical to commercial products. Our DP capabilities includ...
  • Microbial Services

    Product Microbial Services

    We are a world-leader in process development and cGMP manufacturing of proteins derived from a range of microbial hosts including E. coli, P. pastoris and S. cerevisiae .
  • Vaccine Services

    Product Vaccine Services

    Vaccine Drug Product and Finished Goods Services Development and manufacturing capabilities designed with patient safety and centricity in mind. We use robotic systems with single use product path to meet your program needs, providing pre-clinicalbatches up to 10,000 units and commercial batches up to 150,...

FUJIFILM Diosynth Biotechnologies resources (22)

  • News $850 Million USD (¥90 Billion Yen) investment in FUJIFILM Diosynth Biotechnologies to add additional development and manufacturing capacity

    The investments will be made to increase capacity for biologics including recombinant vaccines for COVID-19 and advanced gene therapies in the UK and the US
  • Video Patient Safety: Ensuring Consumer Well-Being

    Pharmacovigilance is not limited to adverse event reporting. Safety data reporting is the first step for detection and mitigation of new drug- related risks, identification of new opportunities to improve medicine and device safety profiles to ensure consumer safety worldwide, guarantee compliance with global and local regulations and increase the commercial interest of the pharmaceutical products.
  • Video Building the Future Pharma Workforce

    Hear about the future of pharma from its current young leaders. Join this session featuring our Future Leader Award nominees as they share their insights on the industry's future and discuss strategies to cultivate the next generation of leaders. Discover how these young visionaries are driving change and shaping a more dynamic and sustainable future for the industry.
  • Video Patient Safety in CDMO Operations: Leveraging Quality and Toxicology Synergies to Accelerate Manufacturing Pipelines

    Even though it should be considered part of our everyday business, is it standard for multimodal CDMOs to truly operate with a holistic quality mindset, prioritizing the health and safety of both workers and patients? At FUJIFILM Diosynth Biotechnologies, quality and safety are two sides of the same coin, with our customers’ patients sitting at the interface of the two. Manufacturing biologically-derived drug substances require pushing the envelope on innovation while maintaining unprecedented quality delivery and meeting regulatory requirements. This mandates a synergistic relationship among safety, quality, and customer stakeholders, specifically in our new product introduction, risk assessment, and risk mitigation processes. This presentation will highlight the unique infrastructure FUJIFILM Diosynth Biotechnologies has built around safety operations and quality, with a focus on our new product introduction and patient risk assessments. The beginning of every drug substance’s manufacturing journey begins with a carefully crafted toxicology assessment and mitigation plan that is predicated on a strong customer mindset, optimizing operational efficiency and accelerating pragmatic risk management solutions. Whether it is an early phase gene therapy or commercial scale protein therapeutic, we partner with customers at every stage of their manufacturing journey to provide appropriate risk management solutions and protect the customers’ patients we ultimately serve.
  • Video Navigating Nitrosamines: Strategies, Safety, and Supplier Impact

    Understanding Nitrosamines: Exploring the presence, formation, and risks associated with nitrosamines in pharmaceuticals. Developing proactive strategies to mitigate nitrosamine risks throughout the supply chain. Implementing safety components and protocols to prevent nitrosamine contamination in drug products.
  • Video Nutraceuticals: From R&D Innovation to Consumer-Driven Delivery Solutions

    The role of nutraceuticals in healthcare is growing in prominence and R&D is fueling innovation across the sector to enhance the safety and therapeutic value of dietary supplements and nutraceuticals. Why tapping into the consumer market can help manage current delivery expectations; How can current formulation technology help develop new and sustainable products; How will AI impact the future of Precision Nutrition
  • Video Panel: Excipient Excellence: The Power of Excipient Grade Selection

    Understanding how excipient quality affects drug performance and stability Exploring the differences between excipient grades and their implications for formulation Strategies for ensuring consistent access to high-quality excipients Selecting the optimal excipient grade for targeted drug delivery.
  • Video HPAPI Safety: Protecting Workers and Patients in Production

    Highlighting common worker safety challenges and opportunities in HPAPI production What practices are required to ensure that workers are protected from highly potent toxins Why its essential to maintain initiatives in product quality, regulations and continuous improvement to help safeguard patient safety during HPAPI production
  • Video Safeguarding the Supply Chain from Ingredient Shortage

    Join our session on safeguarding the supply chain, where we'll discuss strategies for identifying and managing disruption triggers, implementing strategic mapping and monitoring to prevent bottlenecks, and staying ahead of future disruptions through proactive forecasting.
  • Video Navigating Regulatory Landscapes: Ensuring Quality and Compliance in Pharma Ingredients

    GMP principles in pharmaceutical ingredient manufacturing for ensuring consistent quality and safety Overview of auditing processes, including planning, execution, reporting, and follow-up actions, to ensure compliance and drive continuous improvement Comparative analysis of regulatory frameworks across key regions, focusing on differences, similarities, challenges, and strategies for ensuring compliance
  • Video Fujifilm Activities for Liposome and Lipid Nanoparticle Development in the Pharmaceutical Industry

    Fujifilm has been in the healthcare business since the early days of its 90-year history. Today, we provide CDMO services to help our partners develop innovative medicines in the field of biopharmaceuticals. In the field of lipid-nanoparticles (LNPs), Fujifilm's team of synthetic chemists has developed a proprietary library of ionizable lipids. Ionizable lipids are essential LNP components directly related to safety and efficacy. In this presentation, application data of the lipids will be presented. Liposome is a drug-delivery-technology that encapsulates small molecules in stable lipid nanocapsule particles. Even in the world of the 2020s, small molecules are still a promising modality for anticancer drug development. The design of small molecules for hard druggable targets has inherited significant difficulties in reconciling high affinity to targets with other properties: pharmacokinetics, biodistribution and safety. In this session, the presenter will discuss the potential of liposomes in advanced small molecule development and Fujifilm's capabilities.
  • Video Why the Middle East Can Be the New Frontier for Next Generation Medicine

    Join our panel of experts, where we delve into the new frontier in formulation development and how the pharma ecosystem in the Middle East are looking to shape next-generation development
  • Video Panel: Safeguarding the Future of Medicine

    Join our panel as we delve into the role of Critical Medicines Alliance (CMA) initiative that was set by the European Commission. The CMA serves as a consultative platform that unites relevant stakeholders from EU Member States, with its objective is to pinpoint essential areas and priorities for action, offering solutions to bolster the supply of critical medicines in the EU.
  • Video Keynote: Securing Europe’s Pharmaceutical Independence

    The European Union faces a growing challenge in securing its supply of essential pharmaceuticals. Currently, the majority of its active pharmaceutical ingredients (APIs) and finished medicines are imported from Asia, with China being the largest single supplier. This heavy reliance on external sources has raised concerns about the EU's resilience to supply chain disruptions, price volatility, and potential geopolitical risks. To address these concerns, the EESC have set about the Critical Medicines Act to help strengthen the EU's domestic pharmaceutical production capacity.
  • Brochure CMC Support Services

    Your CDMO Partner Advancing Medicines Through Critical Milestones With Expert CMC Support Services
  • Brochure Vaccine Services

    We are an established leader in advancing vaccines from preclinical development to commercial supply across multiple modalities.
  • Brochure Gene Therapy Services

    Our gene therapy process development and manufacturing capabilities are designed to confidently and rapidly progress your products from gene to market through development of robust and reproducible cGMP practices.
  • Brochure Microbial Services

    We are a world-leader in process development and cGMP manufacturing of proteins derived from a range of microbial hosts including E. coli, P. pastoris and S. cerevisiae .
  • Brochure Drug Product & Finished Goods

    End-to-end services designed for patient safetyand centricitywhile offering contracting convenience, cost efficiencies and time savingsOur globally integrated drug product (DP) and finished goods (FG) services offer agileand flexible solutions for clinical to commercial products. OurDP capabilities include aseptic filling in vials, pre-filled syringes or cartridges using state-of the-art isolator technologies,phase appropriate process development, formulation,stability and release testing of clinical and commercial products. Our FG capabilities include assembly, packaging and labeling lines in addition to storage capacity.
  • Brochure Cell Therapy Services

    Your CDMO Partner Advancing Cell Therapies to Patients
  • Brochure Cell Culture Services

    FUJIFILM Diosynth Biotechnologies is a leading provider of cell culture services for biologics, advancing and delivering life changing therapies. We offer complete solutions for cell line development, process development,late phase activities, clinical and commercial manufacturing of a wide variety of biopharmaceuticals.
  • Brochure A World of Opportunity

    "We’re looking for people who share our passion, drive, and energy – what we call Genki – to join our team"

Frequently Viewed Together

  • Product Biosimilars Portfolio

    • Pegfilgrastim (Filed with EMA) • Filgrastim (Filed with EMA) • Trastuzumab (Filed with EMA, MHRA, Received recommendation for marketing authorization in India) • Bevacizumab (Filed with MHRA) • Omalizumab (Global PhIII ongoing) • Denosumab (Global PhIII ongoing) • Ranibizumab (Global PhIII ongoing...
  • Product Biologic drug substance CDMO services

    From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
  • Product RoSS® Shell: Protection of single-use bags

    Protect your single-use bioprocess containers: RoSS® Shells - abbreviated for Robust Storage and Shipping - reduce product loss towards 0%. Compatible with all available sizes and types of single-use bags, RoSS enables standardized and scalable end-to-end process solutions for fluid management and col...
  • Product CARBONYLATION / C-C & C-N COUPLING

    We extensively address the specific needs of the pharmaceutical, food, cosmetics, agrochemicals and specialty chemicals industries with our capabilities in Transition Metal Catalysis (TMC). Complex active pharmaceutical ingredients (API's) are often stereochemically demanding: use of modern synthetic metho...
  • Product Custom Protein Synthesis

    We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
  • Product HANQUYOU(trastuzumab)

    HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) was successfully launched in the U.S., China and Europe, becoming the Chinese mAb biosimilar entering the U.S., the EU and China market. It is indicated for the treatment of HER2 positive early breast cancer, metastatic bre...
  • Product Zinc Oxide Mousse

    Zinc Oxide Mousse: protects & hydrates. Soothes dry, itchy and red skin irritations.
  • Product Onko BCG 100

    BCG for immunotherapy.
    The product is intended for treatment of superficial, epithelial non-invasive urothelial carcinomas (carcinoma urotheliale Ta, Tis, T1)

    1 ampoule or 1 vial with the powder contains:
    Live attenuated bacilli Bacillus Calmette-Guerin, Brazilian BCG Moreau substrain ...
  • Product Primary packaging

    PVC // AluPVC/PVDC // AuPVC/PE/PVDC // AluAlu // Alucontrolled substances packagingpackaging of potent OSDsbottles (glass, plastic, aluminium) with different caps (push-on, screw, snap safe, desiccant capsules)unit dose blister
  • Product Nanoparticles

    Particle Engineering Technologies
    We specialize in particle engineering technologies to address oral bioavailability, lung delivery, modified release and taste masking. In each technology we can support you from proof of concept to commercial manufacturing.

    Nanoparticles
    At Hovione we ...
  • Product DWRX1010 (Colonoscopy Bowel Preparation Drug)

    ※ DWRXs Differentiation Points 1) Maximize compliance in the form of minitablets. 2) Containing simethicone to remove foam in the colon, enabling smooth colonoscopy. 3) Maximizes the convenience of taking medication, and low water intake. ※Development Strategy 1) Non-clinical trial (KR) and patent applica...
  • Product Tofflon Integrated Solution for Biologicals MFG

    Applications: Biosimilars& Therapeutical Protein Nucleic Acid-based Vaccine(mRNA/DNA) Recombinant Viral Vector Vaccine Inactivated/Attenuated Viral Vaccine Gene Therapy
  • Product Apivit D3® 400 drops

    Apipharma d.o.o. Offers a wide range of products which includes  Apivit d3 400 drops. It contains vitamin D which contributes to thenormal functioning of the immune system,maintenance of the normal muscle function and maintenance of normal bonesIngredients in the recommended daily dose (4 drops=0.14 m...
  • Product Chorionic Gonadotrophin (HCG)

    DADELI is a GMP-certified pharmaceutical manufacturer for intermediates,APIs and finished formulations.Our main APIs include HCG, Aprotinin(Currently in China we are the only one to produce Aprotinin complying with the latest EP 11.0), Oxymatrine,Isoniazidum,Egg Lecithin,Daidzein,etc.Warmly welcome all cus...
  • Product Medical pharmaceutical devices

    Gofarm is an expert in medical pharmaceutical devices. The group of medical devices includes not only plasters, implants, diagnostic tests or devices for monitoring the health of patients, such as ultrasound. Among these products there is a group of pharmaceutical medical devices, which, thanks to their m...
  • Product Complete Characterization Testing Solution For Iron Carbohydrate

    Method Development & Validation @ACCUPREC 
    1)Iron Chelation Assay (labile iron by U.V spectroscopy) Validated method
    2)Polymorphic estimation of Iron carbohydrate by XRD
    3)Estimation ratio of Fe3+ to Fe2+ ion validated method
    4)Morphology estimation of iron carbohydrate 
    5)...
  • Product Biopharmaceutical Analysis

    Solvias has a solid reputation with market-leading biopharmaceutical companies for the characterization and QC analysis of monoclonal antibodies (mAbs), glycoproteins, PEGylated proteins and peptides and biosimilars (follow-on biologics).. This means that businesses of all sizes, even smaller biotechs, can...
  • Product Sodium Hyaluronate - Medical grade

    Hyature® is a pharmaceutical grade sodium hyaluronate which can be used as an API or excipient for drugs and medical devices in ophthalmic preparations, intra-articular injections, anti-adhesive preparations, topical preparations for wound healing and soft tissue filler, etc. Hyature® sodium hyaluronate is...
  • Product Linagliptin Tablets - Fineolin

    Linagliptin tablet works by the inhibition of dipeptidyl peptidase-4 (DPP-4) enzyme. This enzyme hydrolyses incretin hormones, including glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1). Linagliptin raises these incretin hormone levels by blocking DPP-4.

    ...
  • Product Drug Substance

    BioDuro-Sundia's Drug Substance manufacturing services support production of small molecule APIs, RSMs and intermediates--both GMP and non-GMP .  We provide a full range of production scale, supporting all stages of drug substance development through IND submission.  Fully integrated CMC ser...
  • Product Deuterated Products

    Specialised in Deuterium Chemistry, Clearsynth Manufactures Deuterated Reagents, Deuterated Intermediates and Deuterated APIs (such as Deutetrabenazine, Deuruxolitinib, Deutivacaftor, Deucravacitinib, Donafenib)

    Production capacity from mg to tons scale.

    Our key reagents are Benzene D...
  • Product PharmaLex

    PharmaLex is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical deve...