• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Solution Center
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Solution Center
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Reducing the Risk of Comparator Sourcing

    Clinical Data Management

    Leveraging AI/ML Analytics for Better Clinical Development Decisions

    What is a Manufacturing Ecosystem and Why are They Growing?

    Get Smart: Integrating PAT Data into Existing Biotech Data Infrastructures
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Catalent Adds New Cryogenic Capabilities at Japanese Facility

    Lifecore Biomedical Enters into $150M New Financing Deal

    WuXi Biologics Receives 2023 ISPE Facility of the Year Award

    Thermo Fisher Expands Steriles Facility in Asia-Pacific Region

    GHO Capital, Partners Group Invest in Sterling Pharma Solutions
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Catalent Adds New Cryogenic Capabilities at Japanese Facility

    "3 Key Trends" with Cory Lewis

    WuXi Biologics Receives 2023 ISPE Facility of the Year Award

    Thermo Fisher Expands Steriles Facility in Asia-Pacific Region

    GHO Capital, Partners Group Invest in Sterling Pharma Solutions
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Catalent Adds New Cryogenic Capabilities at Japanese Facility

    TraceLink, PharmaLink Partner to Simplify DSCSA Compliance

    "3 Key Trends" with Rafael Costa

    Schreiner MediPharm Introduces Tailored Tamper-Proof Closure Seals

    FDA Watch: Is Your Supply Chain at Risk?
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Catalent Adds New Cryogenic Capabilities at Japanese Facility

    "3 Key Trends" with Cory Lewis

    Lifecore Biomedical Enters into $150M New Financing Deal

    WuXi Biologics Receives 2023 ISPE Facility of the Year Award

    Thermo Fisher Expands Steriles Facility in Asia-Pacific Region
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    FDA 2023 Inspection Roadmap: Is “Readiness” in Your Annual Objectives?

    FDA Watch: Are You Suitably Staffed?

    FDA Watch: Is Your Supply Chain at Risk?

    FDA Watch: CDER to Launch Guidance Snapshot Pilot Program

    "3 Key Trends" with Paul Josephs
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Lannett CDMO

    U.S. Pharmacopeia (USP)

    CMC Pharmaceuticals

    LOTTE BIOLOGICS

    Societal CDMO
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Lannett CDMO

    U.S. Pharmacopeia (USP)

    CMC Pharmaceuticals

    LOTTE BIOLOGICS

    Societal CDMO
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • White Papers
    • Podcasts
    • Infographics
    • Microsites
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    ApiJect Systems Approved for $590 Million Loan

    Supports building a U.S.-based facility with surge capacity to produce up to 3 billion single-dose prefilled plastic injectors per year.

    ApiJect Systems Approved for $590 Million Loan
    ApiJect Campus with Gigafactory and Needle Manufacturing Facility. (Architect’s rendering.)
    Contract Pharma Staff11.24.20
    ApiJect Systems Corp. has been approved by the U.S. International Development Finance Corporation (DFC) for a $590 million loan to construct a multi-facility campus enabling the U.S. to more quickly package high volumes of injectable medicines and vaccines in the event of a national emergency, beginning with COVID-19.
     
    Located in Research Triangle Park, North Carolina, a one million sq ft campus will be home to the ApiJect Gigafactory, featuring a pharmaceutical fill-finish facility capable of producing annually up to 3 billion single-dose prefilled injectors. 
     
    New Facility
     
    This new facility brings together the well-established aseptic drug packaging technology known as Blow-Fill-Seal (BFS) with ApiJect's proprietary pen needle-style hubs to package drugs reliably and safely in BFS prefilled injectors. BFS uses pharmaceutical-grade plastic resin to create, fill and seal a strip of 12-25 drug containers per production line every three seconds in a single, highly efficient process.
     
    The Gigafactory will be Biosafety Level 2 (BSL-2) capable and support vaccine candidates that require standard cold storage or ultra-cold storage down to -70 degrees Celsius. Each manufacturing line will be isolated, allowing for up to 15 different drugs to be packaged simultaneously. In addition to its BFS production lines, the ApiJect campus will house two separate special-purpose drug manufacturing facilities to handle drugs such as the next generation of antibiotics and cytotoxic drugs, plus an onsite needle and cannula factory to ensure a domestic supply of this important medical supply chain item.
     
    Partnership with TRC
     
    This new Gigafactory will be the second manufacturing capability developed by ApiJect using BFS technology. Working with a partner company, The Ritedose Corporation (TRC), based in Columbia, South Carolina, and supported by a joint DoD/HHS $138 million contract, ApiJect has repurposed and upgraded, as part of the federal government's Operation Warp Speed, a BFS manufacturing facility at TRC to have the capacity to aseptically fill and finish up to 45 million doses per month of vaccines and other injectable medicines.
     
    "The DFC loan enables us to transition as quickly as possible from the emergency short-term program of 45 million a month of dose capacity created under Operation Warp Speed to the Gigafactory's projected capacity of 250 million doses a month,” said Franco Negron, CEO of ApiJect. “With the Gigafactory, America will have a BSL-2 facility with the flexibility to package up to 15 different drugs simultaneously, and a supply chain sourced 100% in the U.S. This project will ensure America is never caught short in its ability to fill and finish vaccines and injectable medicines necessary to respond to population-wide health threats ranging from COVID-19 to any potential future bio-emergencies."
     
    Negron continued, "Our team at ApiJect worked tirelessly for months on the planning and development necessary to go as quickly and efficiently as possible from groundbreaking to full operation. Our 185-acre campus at Research Triangle Park (RTP), in North Carolina's Raleigh/Durham community was selected after a nationwide search of outstanding potential sites and communities for our first multi-purpose campus location. In the end, RTP is a community with a strong pharmaceutical presence, a highly skilled workforce, and ready access to regional and nationwide transportation networks, among a long list of positives."
     
    Jody Chastain, CEO of The Ritedose Corporation, commented, "ApiJect is a company that makes things happen. I know that from my experience working with them on their emergency program to manufacture single-dose prefilled injectors at our South Carolina facility. The teams from ApiJect and Ritedose did the near impossible by creating in just a few months the capacity to fill and finish up to 45 million prefilled syringes every month. ApiJect's new facility builds off that experience."
     
    The DFC loan will be for 10 years, at an interest rate of approximately 4.5%. Closing of the DFC loan is conditioned on DFC's completion of due diligence and finalization of financing arrangements. Under the loan's terms, an additional $195 million of equity to complete the overall campus must come from non-U.S. government sources. Jefferies Financial Group is handling ApiJect's capital raise.
     
    In keeping with ApiJect's commitment to be an industrial resource for U.S. emergency response, the U.S. Government has the right to reserve as many of the Gigafactory's lines as may be necessary to respond to any national health emergency, such as the COVID-19 pandemic or any similar future event. The Gigafactory will also fill and finish other critical life-saving injectable medicines and vaccines for commercial pharmaceutical clients when not devoted to providing products for national health security.
    Suggested For You
    Andelyn Biosciences, Odylia Therapeutics Partner to Manufacture Gene Therapy for Vision Loss Andelyn Biosciences, Odylia Therapeutics Partner to Manufacture Gene Therapy for Vision Loss
    Lonza Breaks Ground on Commercial Drug Product Facility in Stein Lonza Breaks Ground on Commercial Drug Product Facility in Stein
    EUROAPI Reports Progressive Restart of Prostaglandin Production EUROAPI Reports Progressive Restart of Prostaglandin Production
    Exothera Names Darren Leva as Chief Business Officer Exothera Names Darren Leva as Chief Business Officer
    New CDMO Vector BioMed Launches Operations New CDMO Vector BioMed Launches Operations
    Mikart Invests in New Liquids and Suspensions Suite Mikart Invests in New Liquids and Suspensions Suite
    Pfizer Revenues Soar to Record-Breaking $100B in 2022 Pfizer Revenues Soar to Record-Breaking $100B in 2022
    Lilly to Invest $450M at Manufacturing Site in Research Triangle Park Lilly to Invest $450M at Manufacturing Site in Research Triangle Park
    Stiris Research Inc. Stiris Research Inc.
    Lonza Further Invests in Drug Product Manufacturing Capabilities Lonza Further Invests in Drug Product Manufacturing Capabilities
    pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray
    Rentschler Biopharma to Support Albert Einstein Discovery Center Rentschler Biopharma to Support Albert Einstein Discovery Center
    First Patient is Dosed with Triumvira First Patient is Dosed with Triumvira's Investigational TAC-T Cell Adoptive Immunotherapy
    Recro Pharma Signs Renewable Energy Agreement with Georgia Power Recro Pharma Signs Renewable Energy Agreement with Georgia Power
    Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate  Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate

    Related Breaking News

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
      Andelyn Biosciences, Odylia Therapeutics Partner to Manufacture Gene Therapy for Vision Loss

      Andelyn Biosciences, Odylia Therapeutics Partner to Manufacture Gene Therapy for Vision Loss

      Novel AAV capsid Anc80 enables efficient gene transfer.
      02.01.23

    • Breaking News | Facilities | Industry News
      Lonza Breaks Ground on Commercial Drug Product Facility in Stein

      Lonza Breaks Ground on Commercial Drug Product Facility in Stein

      Milestone for the development of Lonza’s first large-scale drug product manufacturing facility based in Stein.
      02.01.23

    • Breaking News | cGMP Manufacture | Industry News
      EUROAPI Reports Progressive Restart of Prostaglandin Production

      EUROAPI Reports Progressive Restart of Prostaglandin Production

      Majority of production at the Budapest site expected to be back online by mid-April 2023.
      02.01.23


    • Breaking News | Promotions & Moves
      Exothera Names Darren Leva as Chief Business Officer

      Exothera Names Darren Leva as Chief Business Officer

      Leva brings 20 years of broad commercial expertise to Exothera from a range of experiences with CDMOs, therapeutics, and software companies.
      02.01.23

    • Biologics, Proteins, Vaccines | Breaking News | Industry News
      New CDMO Vector BioMed Launches Operations

      New CDMO Vector BioMed Launches Operations

      The biomanufacturing company’s mission is to provide access to high-quality lentiviral vectors and address the vector supply bottleneck.
      02.01.23

    Loading, Please Wait..
    Trending
    • Aurigene Expands Biologics CDMO Capacity
    • Contract Pharma
    • Catalent Adds New Cryogenic Capabilities At Japanese Facility
    • Societal CDMO Partners With Atossa Therapeutics
    • Videobite: Contract Pharma Sits Down with Ryan Lake of Societal CDMO
    Breaking News
    • Catalent Adds New Cryogenic Capabilities at Japanese Facility
    • Lifecore Biomedical Enters into $150M New Financing Deal
    • WuXi Biologics Receives 2023 ISPE Facility of the Year Award
    • Thermo Fisher Expands Steriles Facility in Asia-Pacific Region
    • GHO Capital, Partners Group Invest in Sterling Pharma Solutions
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • New Modalities Hog the Limelight
    • Cell and Gene Therapy is Coming of Age
    • Demand Surges for Cell and Gene Therapy Contract Manufacturing
    • Embracing a New Reality
    • Japan: A Unique Opportunity for Regenerative Medicines and Cell & Gene Therapies
    • Single-Use Technologies Enable Biologic Scaling
    • Get Smart: Integrating PAT Data into Existing Biotech Data Infrastructures
    • FTEs in Drug Discovery
    • Digital Transformation in Pharma
    • What is a Manufacturing Ecosystem and Why are They Growing?
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion
    Verdure Sciences’ Boswellia Ingredient Receives USP Verification
    Coatings World

    Latest Breaking News From Coatings World

    OQ Chemicals Launches Cost-Cutting Program and Organizational Realignment in Germany
    BASF Strengthens R&D with More Powerful Supercomputer
    Safic-Alcan Expands its Presence in Africa with the Launch of Safic-Alcan East Africa in Kenya
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud
    Remote Monitoring, Digital Health Help Advance Wound Care Treatment
    MLM Biologics Developing Wound Infection Prevention Device for Military
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Catalent Adds New Cryogenic Capabilities at Japanese Facility
    Lifecore Biomedical Enters into $150M New Financing Deal
    WuXi Biologics Receives 2023 ISPE Facility of the Year Award
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    How Robots & Artificial Intelligence are Transforming Unilever's Material Innovation Factory
    Top 10 Most Popular Hair Care Brands in the U.S.—Ranked by Searches
    Aloette Cosmetics Launches Daily Mineral Shield Sunscreen
    Happi

    Latest Breaking News From Happi

    Revieve Launches Beauty Technology Platform on Google Cloud Marketplace
    BBW’s Fabric Softener Launch, Ameon’s New Ambassador
    Mielle Organics Taps Angel Reese as New Ambassador
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX Digital, Mexar and hubergroup Top This Week’s Stories
    Richnerstutz AG Acquires an EFI VUTEk Q5r Superwide Roll-to-Roll Printer
    BASF Strengthens Its R&D with More Powerful Supercomputer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Mactac acquires Label Supply, Beontag grows and more
    Sun Chemical releases Spring 2023 Regulatory Newsletter
    Tageos unveils new RAIN RFID inlays
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Corman, Tosama Develop Biodegradable Plastic Tampon Applicator, Trevira Changes Name
    Suominen Appoints SVP, Transformation Management Office
    Minnesota Signs PFAS Ban in Consumer Products
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    AlloSource Launches AlloMend Duo Acellular Dermal Matrix
    TendoNova Inks Partnership With AcCELLerated Biologics
    Stryker Achieves First Surgeries Using Q Guidance System with Cranial Guidance Software
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Smart Skis, Universal Display Top This Week’s Stories
    Wiliot Appoints Antony Yousefian as VP of Climate & Circularity
    HID Unveils Eco-friendly Bamboo Access Cards

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login