Drug Product & Finished Goods

Drug Product & Finished Goods
Product Description

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 include aseptic filling in vials, pre-filled syringesor cartridges using state-ofthe-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.

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...
  • Gene Therapy Services

    Product 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.
  • 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 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 Safe and cost-efficient packaging of pharmaceutical products

    After introducing a new medication to the market, it is always a challenge for pharmaceutical manufacturers to calculate production capacities without incurring economic losses. With support from machine manufacturer Schubert-Pharma and packaging specialist Faller Packaging, manufacturers now have two stro...
  • Product Priiotize Make Ready

    Where artwork meets smart work!Make Ready helps you prepare your healthcare packaging artworks for print production. This tool creates formats based on existing approved layouts. Your original PDF will not be changed via our workflow, but will be enhanced with a metadata concept using our proven techn...
  • Product Sisonal Solution

    Useful to promote the physiological functionalities of the respiratory system and to stimulate the immune defences.

    DOSAGEChildren: 5 ml twice a day.Adults: 5 ml three times a day.

    INGREDIENTSEchinacea angustifolia DC roots E.S. tit. Min. 4% in echinacoside, Propolis minced ...
  • Product Press Pack pails

    Press Pack is a UN certified pail with a screw lid that needs to be pressed on the container for a leak tight closure. The unique press-on screw lid ensures effortless opening and re-closing. Fast, easy and reliable!

    Plastic High Performance Packaging by CurTec is clean, safe, and secure and offer...
  • Product MAST® Autosampling Solution

    A Versatile & Modality-Agnostic Aseptic Autosampling Solution for Reliable On-Line and Near Real-Time Sample Analysis  
  • Product Pharmaceutical Development - Early Phase

    Almac's experienced formulation scientists can develop a range of oral dose formulations for early stage clinical trials.

    With both non-GMP and GMP facilities, flexible and efficient solutions are provided to develop a fit-for-purpose formulation for your early phase clinical trial.
    ...
  • Product Long Life separator System

    Long Life is a monodose cap for active ingredients, as probiotics and multivitaminics, that are prone to biodegradation. Long Life is the only one-piece separator cap available on the world market. The structure of Long Life single-dose cap allows a reduction in water activity thanks to  the sealing w...
  • Product KLEPTOSE® HP HPB - Hydroxypropyl betacyclodextrin

    Kleptose HP and HPB for pharmaceutical applications: parenteral use, syrup oral suspensions. HPBCD increase water solubility and bioavailability.
  • Product Medical Applicators

    Medical applicators are specialized tools designed to aid in the application of creams, gels, or other pharmaceutical formulations. They are produced in cleanroom conditions, ensuring hygiene and safety, and are compatible with a variety of pharmaceutical packaging solutions to enhance user convenience and...
  • Product Aseptic Fill and Finish Processing

    Offering table top units for small batches up to customized high speed fully automated robotic production Filling and Capping Lines for syringes, cartridges, vials, bottles, ampoules, IV bags and various other containers. 
    • Cleaning • Sterilizing • Filling • Lyophilization • Closing •...
  • Product CYTOBLOC®

    Our offer: the security of glass vials with CYTOBLOC®

    - Optimal protection, sleeve with bottom cup to reduce the risk of vial breakage
    - Anti-shock: limits breakage throughout the process, from packaging to preparation in hospital, including transport  - Prevents from spilling and shatt...
  • Product HEKUlab - Automation System for Laboratory Vessels

    With its fully automated production line – the HEKUlab - HEKUMA has created a solution for companies that manufacture laboratory products such as reaction vessels, cuvettes, microtubes. The platform aims to meet all current quality and safety requirements for the processing of laboratory ...
  • Product Cortellis CMC Intelligence™

    Cortellis CMC Intelligence™ product is a comprehensive database of guidelines / granular collection of CMC data requirements for initial registration of small-molecule and biologics drugs around the world that can be used to avoid delays in product approval and successfully bring a drug to the market (laun...
  • Product Protein or Biologics Higher Order Structure Analysis

    We provide higher-order structure analysis to drive insight into the secondary and tertiary structures of protein in “normal “presentation as well as a function of temperature and pH, allowing the study of subtle structure changes that may occur during processing, storage or handling as well as protein agg...
  • Product Smart hearing health

    TympaHealth, one of our start-up clients, launched the world's first all-in-one hearing health assessment system, a portable smartphone-enabled otoscope with accompanying smartphone app. Since then, the novel device has been awarded Gold in the internationally recognised UX Design Awards for its innov...
  • Product Wallet Packaging

    We are also highly experienced in the handing of controlled substances.

  • Product Mikron Tray Handler - highly configurable handler

    Mikron supplies a highly standardized tray handler capable of dealing with a range of applications from single tray to multiple stack, for tray sizes from 300 x 400 to 400 x 600 mm, and designed for parts that are susceptible to damage or contamination if fed using other methods such as bowl feeders. q...
  • Product Corning® Viridian® Vials

    Corning® Viridian® vials, externally coated Type 1 borosilicate vials, are a drop-in solution made with 20% less glass material, enabling up to a 30% reduction in Cradle to Gate, Scope 3 emissions.

    Viridian vials can protect product quality and boost filling line productivity – helping...
  • Product Aidaptus

    Aidaptus has been awarded the Red Dot award for the category Product Design 2023

    Benefits

    - Aidaptus® is a 2-step single use auto-injector platform, with a versatile design and  intuitive drug delivery.

    -  Aidaptus® accommodates both 1mL and...
  • Product Snip guard devices Medic'UP®

    Safety device to remove injection pen needles
     
    •    Safe and easy to use

    •    Fits with all existing pens and needles in the market.

    •    Waste management to protect the users environm...
  • Product Ampoules

    Our ampoules are mostly used for the human- and veterinary medicine, cosmetics and for chemical substances. Please find some more information including the standard sizes on our website: https://pharmaglas.de/ampullen.html
  • Product LDPE Bottles

    We provide an unmatched combination of product offerings & packages, design & innovation capabilities to leverage new technology & patient insights, & manufacturing expertise in pharmaceutical packaging

    To make Berry a part of your Healthcare manufacturing process, please contact...
  • Product MINILINE

    MINILINE can be configured for any product or container requirement. Furthermore it can be very quickly changed to another format. Start up is immediately at the required production speed, thus giving a high OEE even when running small batches. The GMP design allows for easy cleaning with exceptional v...
  • Product Primary Packaging for IV-solution bags

    PolyCine offers:

    Primary Packaging Films for IV-solution bag
    Filling and transfer tubes for Primary Packaging
    Hot Foils for IV-solution bag / primary container printing
    Compounds for Primary Bag Connectors & Ports

  • Product Customized solutions drug delivery systems

    Customized drug delivery systems – from the concept development through industrialization to assembly, and pharmaceutical filling. We cover the entire spectrum of delivery types: inhaler, syringes, pen systems, auto injectors and infusion sets as well as lab disposables and point of care tests.
  • Product Analytical Lab Services

    Analytical Services

    The analytical services team has vast expertise and experience in extractables and leachables, particle analysis, container closure integrity, and performance and packaging/delivery systems among other methodologies. As a result of our understanding of materials and delivery ...
  • Product Injectable vials & Ampoules in tubular glass

    SGD Pharma India tubular vials and ampoules are made of neutral borosilicate glass from the 5.0 expansion
    coefficient family. The tubular glass used by SGD Pharma India is supplied by globally renowned glass tubing
    manufacturers like Schott, NEG, Corning and others as per the specific...
  • Product H-Track Printing Machine

    This machine has the ability to print 1 side of a caplet or soft gel. This machine can be used for multiple products because of its easy setup and quick change parts. Carrier bars with 6 pockets each, enable this machine to print up to 150,000 units per hour. Its features includes: a servo driven, easy to ...
  • Product PENTAFILL®

    TekniPlex Healthcare can provide its customers with machines for the filling of single-dose containers. The series of Pentafill machines guarantees total flexibility to meet a wide range of needs, for production on an industrial scale or small production batches, for laboratory tests or research and develo...
  • Product Small volume parenteral manufacturing (SVP) - 2 to 5 ml

    Weiler engineering provides wide range of pharmaceutical and healthcare applications which includes small volume parenteral manufacturing (SVP) - 2 to 5 ml. It belongs to injectable products/SVP /LVP products category. It is a small volume Parenterals in the 2 to 5 mL range most commonly utilize a luer loc...
  • Product Self sealing closures

    Intrinsic-sealing, also known as self-sealing or conical sealing, is the simplest and least expensive method of sealing a bottle tightly. The advantage is that only one raw material specification is required. Simple, but efficient. The closure is given a conical sealing lip on the inside of the closure in ...
  • Product Biocompatibility & Toxicology Testing

    Nelson Labs offers a full trifecta of services to meet the requirements of ISO 10993 for Extractables & Leachables, Biocompatibility and Toxicological Assessments of medical devices. Biocompatibility testing is very common in the medical device industry. However, with 24 possible categories, each with...
  • Product PET jars

    Suitable for primary packaging of Pharmaceuticals. Our plastic PET jars come in various shapes and sizes and also with matching closures. From small Pill jars to large Jumbo jars. Whether it concerns square, round, cylindrical or PET jars with child-resistant closures (CRC), we have the PET jars you are...
  • Product Dental spray pumps, crimp on neck, 110mm long nozzle, for glass vial

    Key Features: 1. 20mm crimp on neck
    2. Dosage: 45mcl to 220mcl per stroke, +/-10% tolerance
    3. Easy priming and repriming
    4. Individual packing available
    5. Produced in Class D clean room
    6. Packing: poly bag + carton + plastic pallet

  • Product Plastic injection molds

    Mold design and manufacturing for Medical and Diagnostic in Vitro plastic devices.
  • Product Overlabelling

    With specialised machinery, we also apply pharmaceutical stickers and labels to folding cartons and other products, issuing the corresponding reconciliation report.
  • Product Surflo™ Winged Infusion Set with/without Needle Protection

    Surflo™  Winged Infusion Sets with disposable infusion apparatus, are used for intravenous injection. 

    Surflo™ Winged Infusion Sets with needle protection (Surshield™) minimize the risk of accidental needle stick. Once activated, the needle is perman...
  • Product Virtual prototyping

    A virtual prototype is a digital version of a new component. Instead of creating it in the real world, it is created on a computer, ready for testing in the virtual world.

    Computor-based testing-The real benefits of virtual prototyping can be seen when a virtual component is incorporated into a ...
  • Product Oral Dosing Syringes

    Oral Dosing Syringe marked with MDR CE is designed & manufactured by Bharat Rubber Works. Oral dosing syringes are designed for safety and easy drug delivery. It is much easier to take liquid medication from solid pills. From babies who refuse medication to the elderly with debilitating diseases, oral ...
  • Product Atec Transfer Port - ATP

    The Atec Transfer Port acts as a closed transfer lock to enable sterile transfer of components into and out of isolators and RABS. A unique locking system was developed to guarantee both operator safety and product integrity. The ATP cannot be opened unless the Beta port is correctly docked. This also mean...
  • Product Managed Markets Data & Analytic Solutions

    Fundamental to the success of your market access strategy is clear visibility into payer, provider and patient behavior. IQVIA's comprehensive real-world database includes lifecycle transactions, which offer the critical level of detail required to untangle the complex interaction of payer utilization mana...
  • Product BOTTLES WITH ORAL AND NASAL DISPENSER

    Spray bottles for pharmaceutical use (a closure is a part of the container) are used for packing liquid pharmaceutical products (magistral medicine, galenical medicine, ready-made medicines). They can be in direct contact with the product.
  • Product Vial Protect Pack - VPP

    Our Vial Protect Pack is designed to provide shatter proofing and high containment for your hazardous drug vials. Our Vial Protect Pack system covers the entire vial body and protects against any hazardous drug residue on the vial surface. The risk of potential exposure to hazardous drugs is also ...
  • Product Cleanroom plastics injection moulding by GEMÜ

    GEMÜ manufactures an extensive range of plastic injection-molded components, designed to meet the highest cleanroom standards for medical, pharmaceutical, and diagnostic applications. Our state-of-the-art facilities include partially and fully automated injection molding machines, operating in ISO Class 7 ...
  • Product EVERYTHING UNDER ONE ROOF

    De Budelse offers another big advantage: the entire production process of cardboard packaging takes place under one roof. From digital printing and offset printing to UV coating, and from die-cutting, folding and gluing the cardboard boxes to placing braille and gluing the leaflets inside those same boxes.
  • Product PHARMACLEAN® Covers and Sterility Protection solutions

    Pharmaclean products in DuPont™ Tyvek® material, for sterilisation and protection from dust, particle sand microorganisms, are designed to offer total safety and resistance. They are customisable and easy to use. Unaffected by autoclave sterilisation processes.All products come along with a certificate of ...
  • Product Vials Filling and Capping - ISOL-AIR Series

    ISOL-AIR are containment cabinets suitable for product and/or operator protection within aseptic filling processes of vials and syringes.

    - Configurable as Closed RABS or Isolator;- Aseptic transfer connections by different types of RTP (Rapid Transfer Ports);- Integration of Environmental Mon...