• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    SARS-CoV-2 R&D: Is It Over?

    Sustainability: A New Threat or Opportunity for CDMOs?

    Advanced Therapy Manufacturing

    Advanced Therapy Packaging Trends

    CEO Spotlight: Darren Head
    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
    iECURE Enters Agreement with Center for Breakthrough Medicines

    CPDC Enters Clinical Manufacturing Deal with CellBion

    Olon to Build New R&D Center in Italy

    Hanmi Fine Chemical Launches CDMO Business

    DFE Pharma Opens India CoE for Fast-Track Formulation Services
    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

    iECURE Enters Agreement with Center for Breakthrough Medicines

    CPDC Enters Clinical Manufacturing Deal with CellBion

    Olon to Build New R&D Center in Italy

    Hanmi Fine Chemical Launches CDMO Business

    DFE Pharma Opens India CoE for Fast-Track Formulation Services
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Selecting a CMO Partner for Sterile Injectable Manufacturing

    Royalty Pharma and Jefferies Invest $111M in ApiJect

    Cryoport Acquires Cell&Co BioServices for €6.2M

    Challenges of Developing Large Volume Drug/Device Combination Products for Parenteral SC Delivery

    Yourway Adds Capacity for Controlled Ambient Storage
    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

    CRO Market Insights

    Hanmi Fine Chemical Launches CDMO Business

    DFE Pharma Opens India CoE for Fast-Track Formulation Services

    Helsinn Establishes New R&D Hub in the U.S.

    CureVac, myNEO Partner on Antigen Targets for mRNA-Cancer Vax Development
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    FDA Inspection Trends Update

    Phase-Appropriate cGMP Considerations for Cell and Gene Therapy

    Sustainability: A New Threat or Opportunity for CDMOs?

    In Pursuit of Sustainability: How the Biopharma Industry Can Contribute

    Conducting Clinical Trials During the Pandemic: What Did We Learn?
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Baxter BioPharma Solutions

    Aphena Pharma Solutions

    Alcami

    Biosynth Carbosynth

    IDT Biologika
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Baxter BioPharma Solutions

    Aphena Pharma Solutions

    Alcami

    Biosynth Carbosynth

    IDT Biologika
    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
    • Supplier Microsite
      • 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.)
    Related CONTENT
    • Jubilant HollisterStier
    • Lonza Further Invests in Drug Product Manufacturing Capabilities
    • pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray
    • Rentschler Biopharma to Support Albert Einstein Discovery Center
    • First Patient is Dosed with Triumvira's Investigational TAC-T Cell Adoptive Immunotherapy
    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
    Jubilant HollisterStier Jubilant HollisterStier
    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
    CuriRx Launches CuriLytics Platform for Biotherapeutic Development CuriRx Launches CuriLytics Platform for Biotherapeutic Development
    Thermo Fisher Launches Gibco AAV Production System Thermo Fisher Launches Gibco AAV Production System
    Rentschler Biopharma Appoints Dr. Christian Schetter as Chief Scientific Officer Rentschler Biopharma Appoints Dr. Christian Schetter as Chief Scientific Officer
    Everest Medicines, Sinovent, SinoMab Enter Global BTK Inhibitor Mfg. Pact Everest Medicines, Sinovent, SinoMab Enter Global BTK Inhibitor Mfg. Pact
    Tevogen Completes Tech Transfer to CDMO BioCentriq Tevogen Completes Tech Transfer to CDMO BioCentriq
    BioVaxys Reports Progress on Covid-19 Vax Candidate BioVaxys Reports Progress on Covid-19 Vax Candidate
    Vaccine Developer Intravacc Adopts Hybrid Business Model Vaccine Developer Intravacc Adopts Hybrid Business Model
    Clean Cells Expands Bioproduction Capabilities Clean Cells Expands Bioproduction Capabilities

    Related Content

    • Jubilant HollisterStier

      Jubilant HollisterStier

      Jubilant HollisterStier is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids.
      04.22.22

    • Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
      Lonza Further Invests in Drug Product Manufacturing Capabilities

      Lonza Further Invests in Drug Product Manufacturing Capabilities

      New filling line to process various modalities, including monoclonal antibodies, bioconjugates, viral vectors, and other gene therapy products.
      09.22.21

    • Breaking News | Clinical Trials
      pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray

      pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray

      According to the study, the novel prophylactic nasal spray prevented infection from SARS-CoV-2, the virus that causes COVID-19.
      09.22.21


    • Breaking News | Drug Development | Drug Discovery | Industry News
      Rentschler Biopharma to Support Albert Einstein Discovery Center

      Rentschler Biopharma to Support Albert Einstein Discovery Center

      Donates 50,000 Euros to support the creation of the discovery and activity center in Ulm.
      09.22.21

    • Breaking News | Clinical Trials
      First Patient is Dosed with Triumvira

      First Patient is Dosed with Triumvira's Investigational TAC-T Cell Adoptive Immunotherapy

      TAC01-HER2 was developed for the treatment of HER2-overexpressing cancers.
      09.21.21

      Trending
      • Catalyst Biosciences Sells Complement Portfolio To Vertex Pharmaceuticals | Contract Pharma
      • Hanmi Fine Chemical Launches CDMO Business | Contract Pharma
      • CureVac, MyNEO Partner On Antigen Targets For MRNA-Cancer Vax Development | Contract Pharma
      • Mirum Pharmaceuticals Acquires San Diego-based Satiogen | Contract Pharma
      • Insmed Appoints Drayton Wise As Chief Commercial Officer | Contract Pharma
      Breaking News
      • iECURE Enters Agreement with Center for Breakthrough Medicines
      • CPDC Enters Clinical Manufacturing Deal with CellBion
      • Olon to Build New R&D Center in Italy
      • Hanmi Fine Chemical Launches CDMO Business
      • DFE Pharma Opens India CoE for Fast-Track Formulation Services
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Sustainability and the Biopharma Industry
      • Contract Manufacturing During COVID
      • Orphan Drugs in the United States
      • CEO Spotlight: Peter DeYoung
      • CEO Spotlight: Darren Head
      • Advanced Therapy Packaging Trends
      • Advanced Therapy Manufacturing
      • Sustainability: A New Threat or Opportunity for CDMOs?
      • SARS-CoV-2 R&D

      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

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      Nippon Paint Automotive Americas Appoints Robert Angart CEO and President
      Sustainability, Economy are Focus of BCF’s Annual Conference
      Demand for Rhino Shield Increases
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      MPO's Most-Read Stories This Week—May 28
      New Breast Implant Surgery Guidelines to Enhance Patient Safety
      Rhythm Management Group Debuts RhythmSynergy Tech Platform
      Contract Pharma

      Latest Breaking News From Contract Pharma

      iECURE Enters Agreement with Center for Breakthrough Medicines
      CPDC Enters Clinical Manufacturing Deal with CellBion
      Olon to Build New R&D Center in Italy
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      K-Beauty Brand Siita Shares Plastic Decomposition Technology with the Beauty Industry
      Shellworks Raises $6.2 Million in Seed Funding
      Ulta Beauty Reports Record First Quarter 2022 Results
      Happi

      Latest Breaking News From Happi

      Global Skincare Treatment Devices Market Expected to Grow at Over 11.5% CAGR Rate Through 2028
      Technology Cuts Plastic Decomposition from 500 Years to Three Months
      Honeywell Addresses Critical Issues Such as Sustainability, Workforce Training and Digitalization
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Flint Group, New Inks from Siegwerk and Zeller+Gmelin Lead This Week’s News
      Orion to Finish Gas Black Expansion in Germany by Early 2023
      Richard Childress Racing Shows Off New Wraps for 2022 NASCAR Season
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      UPM Raflatac accelerates label growth with acquisition
      Labelexpo Asia 2022 postponed
      Teklynx software helps Top Clean Injection validate labels
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      ODT's Most-Read Stories This Week—May 28
      Toetal Solutions Raises $1.02 Million in New Financing
      ManaMed's ManaSport Wearable Ultrasound Earns FDA Nod
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: OPV’s Future, Graphene Flagship and Japan Display Top This Week’s Stories
      SEMI Foundation Receives $1.5 Million Grant to Bolster Michigan’s Semiconductor Talent Pipeline
      onsemi Recognized by Fortune 500 for Its Transformation Journey

      Copyright © 2022 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