ApiJect is proud to serve as the catalyst for well-known experts to share their knowledge on the many aspects of fill-finish. Hosted by long-time industry veteran, Rizwan Chaudhrey.
Making Every Dose Better
The Prefilled ApiJect Injection Platform: Discover how ApiJect™ can open new markets and reduce costs for your injectable products.
Chats with Chaudhrey: “Life Cycle Assessment of the Prefilled ApiJect Injector”, Jon Ellenthal
Insight into the recently published peer reviewed study compares the environmental footprint of the Prefilled ApiJect Injector device to widely used traditional glass syringe options.
“Vaccine Delivery Struggles”
Vaccines and vaccination are often in the news – perhaps never more than in the last four years, as the world found its way through the COVID pandemic. They were high on the agenda of the recent World Health Assembly, held last month in Geneva, with encouraging stories of vaccination campaign successes, and frustrating stories of vaccination obstacles and unrealized hopes.
In the most recent installment of “From the Front Line,” Paul Rutter, MD chats with Mark Kamau, a human-centered designer residing in Nairobi. Mark specializes in designing products tailored to African and emerging markets, prioritizing user engagement and context to ensure that these products effectively serve their intended purposes.
Pharma Partner Introducing New Sterile Vaccine Product
HIPRA, an EU-based biopharma company, was developing a recombinant protein vaccine against SARS-COV-2 and was looking for an experienced partner to work with in order to improve the adoption of its vaccine in global markets.
Carles Fàbrega and Ed Kelley discuss the One Health agenda in this episode, which goes beyond the usual global health topics. One Health focuses on the connection between human and animal health and its implications for issues like antimicrobial resistance, vaccine development, and epidemics in the future.
Offering Access to Injectable Medicines: The Prefilled ApiJect Injector
Test Drive Our Technology
A Novel Prefilled Drug Delivery Platform: Expanding Access and Distribution
Meet PJ Kim
“The Intersection of Healthcare and Conflict”
Today, the world is facing the highest number of violent conflicts since the Second World War. According to the United Nations, 2 billion people — a quarter of humanity — live in places affected by such conflict.
“Faster and Better-How AI is Reshaping Vaccines and Medication Research”
Artificial Intelligence (AI) promises to increase the efficiency of care as systems strive towards these goals.
Sterile Fill-Finish Market & Technology Trends
ApiJect expert discusses sterile fill-finish market trends and ApiJect’s platform technology.
Accelerating Access: The Future of Prefilled and Plastic
Learn more about the need for greater fill-finish capacity in the pharmaceutical industry highlighted by the pandemic, and how the Prefilled ApiJect Injector platform aims to meet this need.
Making Medical Injections Safe and Accessible
Anchored by two well-known medical technologies – BFS fill-finish and high precision injection molding – ApiJect’s novel drug delivery platform offers safety, cost, supply chain, and eco advantages over existing devices. Learn more with this interview with Jon Ellenthal, President at ApiJect.
Pet Owners and Small Farms Worldwide Need New and Better Medical Injection Options to Keep Their Animals Healthy
Animal health and human health are closely linked. At home, healthy pets make happier, longer-lived companions. On farms, sick animals put human health at risk, while healthier livestock reduces the spread of disease and produces safer food.
When Injections Spread Disease
Worldwide use of contaminated vials and syringes in clinical settings leads to 1.3 million deaths per year…and spreads disease to millions.
Blow-Fill-Seal Prefilled Injectors Support Many Use Cases for Global Impact
An affordable, single-use prefilled injector* could open new opportunities for coverage, access, and equity for billions of people around the world.
“Revolutionizing Prefilled Injectables through Innovative Technology”
Learn how scalable fill-finish, a compact supply chain, and cost-efficient manufacturing can solve drug delivery challenges for prefilled injectables.
As the demand for parenteral products increases, companies are seeking solutions that offer the benefits of prefilled formats while reducing lead times and costs associated with sterile fill-finish services. The projected growth of sterile injectables in the next decade makes finding such solutions crucial. Aseptic manufacturing technology combined with injection molding offers a more flexible and resilient supply chain, even during global crises such as the COVID-19 pandemic.
In this webinar, a case study will be presented that showcases the advancement of product design based on customer needs, especially in the context of injectables. The study will demonstrate the progression from using multi-dose glass vials to single-dose prefilled injectors, and how this evolution aligns with the future of technology being in plastic. The speakers will emphasize the logical progression with a focus on integrating quality, convenience and safety into innovative technology. The FDA has outlined key considerations for transitioning to innovative combination products which will also be discussed. By following a device development approach, a modular and customizable design can be achieved, offering endless possibilities for creating the appropriate drug delivery solution.
Presenters
Joe Wojcik
How does ApiJect ensure that the temperature changes which occur during BFS manufacturing do not negatively impact the drug product? Can Blow-Fill-Seal handle ultra-low temperatures? Can Blow-Fill-Seal be used for vaccines?
“Crossing the Last Mile: Delivery Systems”
After the surge in medical technological advancements brought on by the COVID-19 pandemic and shift toward digital innovations in healthcare, we may find ourselves asking, what’s next?
“An Insight into the Repercussions of Medical Waste and its Disposal”
A safe injection does not guarantee safety for a community unless disposed of correctly. This article aims to address a topic which is by no means novel but is often overlooked when considering safety issues surrounding injections: safe disposal and afterlife of medical waste.
Joe Wojcik
Temperature is everyone’s first question. How does temperature play a major role? Does the heat affect the drug product? How is the temperature controlled?
Component Supply Chain
Josh Myers, MBA
Are polymers readily available? Does ApiJect stockpile resin/polymer? What manufacturing capacity does ApiJect have available today?
Prefilled Injectors
Dave Boerschel
How do you prevent “suck-back” where blood is drawn into containers? Is a prefilled syringe the same as an auto-injector?
”Self-care and the Rapidly Changing Market of Obesity Drugs”
Could anti-obesity drugs recently approved by the FDA and other regulators make a difference in one of the world’s biggest public health challenges?
Injector Components
Josh Myers, MBA
What are the components of the prefilled injector? Does the needle hub also have components? What Type of plastic is used on the container, hub, and components?
Special Feature: Parenteral Drug Delivery: Could a Dose of AI Improve Development?
Drug Development & Delivery, Issue: May 2023
While the industry is just at the precipice of discovering what AI can do for injectable delivery, this exclusive Drug Development & Delivery annual report highlights the strides that companies are currently making toward improving dose accuracy, integrating design safety, and accelerating time to market.
Component Manufacturing
Josh Myers, MBA
Who manufactures ApiJect’s components? What is manufactured at TRC? What about Fareva?
Pharmaceutical Packaging 2
Jon Burgess
Are any of those packaging functions trade-offs, or are they all complimentary? Have there been major advances in packaging in the last, say ten years?
“The End of COVID-19? Not for Everybody.”
We are now entering our fourth spring of the global COVID pandemic. But this spring looks far different from the last three. April of 2020 saw the world…
“The Long Road with Long COVID”
With infections dropping, COVID-19 seems to have become obsolete. What’s next?
Pharmaceutical Packaging
Jon Burgess
What logistical challenges arise concerning the supply chain management for different packaging materials? What are the road tests that a glass or plastic vial must pass for pharmaceutical use?
Inside the Machine Shop: Flame Welding
Inside the Machine Shop: Mold Grinding 2
Inside the Machine Shop: Spark Welding
Inside the Machine Shop: Prototype Mold Cutting 2
Unlocking Blow-Fill-Seal for Injectables
Partnering: Pharma Companies
Reimagining Injectable Drug Solutions. At ApiJect, our experts work with your team to design BFS-based prefilled drug delivery systems for your drug product.
Handling Drug Product
Joe Wojcik
What formulations can ApiJect handle? What about nitrogen overlay? Describe ApiJect’s end-to-end development capabilities to ensure the right device is created.
Prefilled ApiJect Injector*—0.5mL Delivery
Elements of the Prefilled ApiJect Injector
Five Functions of Packaging
Jon Burgess
What are the five functions of pharmaceutical packaging?
“When Business as Usual is Bad for Public Health”
In January 2023, the U.S. FDA announced its plans for the future of COVID vaccination. COVID vaccines will follow the path…
Meet Stephanie Summe, Sr. Director, Device Development
Meet Molly Weaver, PhD, Chief Technology Officer
Prefilled Injector Supply Chain
Dave Boerschel
How does BFS perform in sterility and particulate matter requirements?, Why can BSF containers be harder to physically inspect?, How many BFS containers would be inspected? and Is human visual inspection ever supplemented with machine photography and analysis?
The Field Research Network was created to gather qualitative and quantitative data from real-world settings through ground level investigations, particularly in low- and middle-income countries. Resulting information helps ApiJect engineers develop medical devices for all global markets.
Blow-Fill-Seal Container Inspection
Philip Leslie
How does BFS perform in sterility and particulate matter requirements?, Why can BSF containers be harder to physically inspect?, How many BFS containers would be inspected? and Is human visual inspection ever supplemented with machine photography and analysis?
Pharmaceutical Packaging Standards (Pt. 1)
Jon Burgess
What have been the industry standards in packaging? and Who sets these industry standards?
Blow-Fill-Seal Terminal Sterilization
Philip Leslie
What is the difference between conventional terminal sterilization and bulk sterilization?; With terminal, what other methods are used besides heat?; Has there ever been a time where terminal was used with BFS, or when it’s desirable?; What kind of equipment/space is needed? and With BFS, is sterilization always done on site?
Drug Stability Testing & Formulation
Joe Wojcik
How is drug stability maintained during BFS fill-finish?; Is the drug mixing done onsite, or at the pharmaceutical supplier?; How is stability testing handled?; What are ApiJect’s formulation capabilities? and In addition to viscous products, what are the other formulation challenges?
Launch of Did You Know: Blow-Fill-Seal
Molly Weaver, PhD
Short, technical Q&A videos where ApiJect experts provide responses to questions about BFS technology. Such as, “How does BFS handle light and oxygen sensitive drug products?” and “Does BFS manufacturing create less pollution and waste byproduct volume than glass?”
“Vaccines Beyond COVID-19”
mRNA technology was launched originally not for COVID-19 but for personalized vaccines for chronic diseases like cancer. Can we do a better job this…
“From Measles to Malaria- Case for Building Delivery into Development for Vaccines & Drugs”
Live with Chaudhrey: Paul Rutter, MD At the World Vaccine Congress Europe. Paul shares insight on building delivery into the development of vaccines and injectables.
Blow-Fill-Seal has a Compact Supply Chain
Blow-Fill-Seal for Sterile Liquids, Biologics and Potent Compounds
Blow-Fill-Seal is Advancing Fill-Finish & Injection Technology
Chats with Chaudhrey: “Prototype Mold Making for BFS Processes”, Jon Burgess
Rizwan chats with Jon to learn more about ApiJect’s recently opened Technology Development Center in Florida and prototype mold making for Blow-Fill-Seal processes.
“Leading After Emergency”
After pages of goals and recommendations on responding to COVID-19 and preparing for the next pandemic, one thing is still lacking: leadership.
Filling Tests on Rommelag Bottlepak 434 Pt. 2
The Benefits of Plastic Injection Molding
Using the latest in Injection Molding Tooling innovations, components can prototyped to a production quality level.
Filling Tests on Rommelag Bottlepack 434 Pt. 3
Filling Tests on Rommelag Bottlepak 434 Pt. 1
“Solving “Impossible” Problems Starts Here”
The chasm between the West and rest on healthcare quality and access seems insoluble. But we can narrow the gap.
Overview of Blow-Fill-Seal Manufacturing and Secondary Packaging Line
Inside the Machine Shop: Prototype Mold Cutting
Inside the Machine Shop: Prototype Mold Grinding
Fill-Finish Podcast 6 – “Current State and Trends Impacting Fill-Finish from Formulation through Commercialization”
Participants
ApiJect Platform Uses Efficient BFS Manufacturing Processes
Blow-Fill-Seal Creates and Fills a Container in a Continuous Process
“On Polio, Monkeypox, and COVID-19”
The Lessons We Can, and Cannot, Take
“The Most Important Faces in Global Health”
They are the children that modern medicine forgot, or utterly failed to reach.
How Blow-Fill-Seal Delivers Operational Efficiencies and Aseptic Fill-Finish
with Joe Wojcik, Senior Director, Pharmaceutical Development Services
Pharma expert, Joe Wojcik, discusses the technical factors and requirements that make BFS an “advanced aseptic process” for fill-finish, and why BFS has relatively low capital requirements
“Turning Obstacles into Assets”
Seeking to improve global health access? Learn to leverage limits and constraints as springboards for innovation
Fill-Finish Podcast 5 – “Temperature Sensitive Biologics and Blow-Fill-Seal”
Participants
“How Global is Global Health?”
Traditional funding streams continue to favor northern institutions. Is it time to change?
“Behind the Headlines”
Very few people had heard of monkeypox a month ago. Now – despite tough competition from other major global events…
Fill-Finish Podcast 4 – “Evolving Trends in Aseptic Processing”
Participants
“ApiJect: Helping to Open New Markets & Reduce Costs for Injectables”
“Are genetically modified mosquitos the solution to malaria?”
Thinking about known-unknowns and unknown-unknowns.
“Hidden in Plain Sight”
Why Unsafe Injections Remain a Global Challenge
“Production For the Last Mile”
We have plenty of COVID vaccines and doses. The real challenge now is delivering them the last mile.
“Sometimes There is an Obvious Solution”
Problem: not enough doctors and nurses; millions of people to vaccinate. Solution: let Community Health Workers do it.
Technology Development Center
The ApiJect Technology Development Center in greater Orlando, Florida is focused on helping pharmaceutical companies prepare their drug product for high-speed, high-volume production in a new type of scalable prefilled syringe that is made largely using the Blow-Fill- Seal aseptic process.
“What are the real COVID mortality numbers?”
Estimates from WHO are pending; meanwhile a study in The Lancet suggests the true number of global fatalities from COVID may be 3x higher than indicated…
Episode 4: “Evolving Trends in Aseptic Processing”*
Participants
We’ve Lost a Giant”
Dr. Paul Farmer led by personal example and total commitment. Here are 3 secrets that made him incredibly inspiring – and effective.
Fill-Finish Podcast 3 – “Global Supply Chain Management and Capacity Planning”
Participants
Join the ApiJect team! We’re always looking for passionate teammates.
We envision a world where every country can safely, locally, and cost-effectively package and deliver all of the essential injectable medicines and vaccines its citizens need to live long, healthy lives.
Global Manufacturing Supply Chain Resiliency
We have created a compact and flexible supply chain that can be almost entirely domestic in major markets. This is because we rely on two robust manufacturing technologies to make our platform: Blow-Fill-Seal (BFS) aseptic filling and plastic injection molding.
Chapter 35: How to Get Started with Blow-Fill-Seal
Chapter 34: – BFS Delivery System Approach
Chapter 33 Temperature Management
Chapter 32: The Use of Foil Wrap in Blow-Fill-Seal
Chapter 31: Particulate Inspection in Blow-Fill-Seal
Chapter 30: Leak Detection with Blow-Fill-Seal
Chapter 29: Blow-Fill-Seal Punching, Engraving, and Separating
Fill-Finish Podcast 2: “The Past, Present, and Future of Advanced Aseptic Facility Design”
Participants
Chapter 28: Blow-Fill-Seal Machine and Support Systems
Chapter 27: Areas of a Blow-Fill-Seal Line
Chapter 26: Blow-Fill-Seal Molds
Chapter 25: Blow-Fill-Seal Manufacturing Efficiencies
Chapter 24: Blow-Fill-Seal CapEx and Fixed Costs
Chapter 23: Blow-Fill-Seal Equipment
Chapter 22: Space and Utilities Needed for Blow-Fill-Seal
Chapter 21: Blow-Fill-Seal Filling Suite Installation
Chapter 20: Sensitivity
Chapter 19: Compatibility and Feasibility Testing with Blow-Fill-Seal
Chapter 18: Cost Advantages of Blow-Fill-Seal
Chapter 17: Flexible Scaling of Blow-Fill-Seal
Chapter 16: Compact Supply Chain
Chapter 15: Breakage Resistant
Chapter 14: Transportation and Blow-Fill-Seal
Chapter 13: High Productivity with the Blow-Fill-Seal Process
Chapter 11: Blow-Fill-Seal’s Compact Manufacturing Footprint
Chapter 10: BFS is a Cost-Efficient Manufacturing Process
Chapter 9: Sterility Assurance
ApiJect Prefilled Injector
The Prefilled ApiJect Injector* is a delivery system designed to bring together the benefits of prefilled syringes with the manufacturing efficiency of multi-dose presentations. Watch the Video by clicking below.
We are ApiJect
We are a team of passionate and dedicated people. Our mission is to make injectable medicines and vaccines safe and accessible to everyone. Click the button below to watch the video.
BFS Temperature Management
Our BFS manufacturing experts employ a variety of techniques to consistently control the drug product’s temperature throughout the fill-finish process.
Blow-Fill-Seal
Our experts marry the efficiency and flexibility of BFS with attachable plastic components to create drug delivery systems. This approach has the potential to enable scalable and efficient manufacturing of single-dose prefilled syringe which can typically only be found in multi-dose presentations.
Partnering for Success
We help pharma companies fill-finish sterile liquids by working together to create Blow-Fill-Seal based, prefilled drug delivery systems, and then assist in the fill-finish process. The result is a prefilled drug delivery system that can be flexibly manufactured at various facilities that use BFS.
ApiJect Company Profile
ApiJect is a medical technology company that seeks to improve how companies fill-finish injectable medicines. We do this by working with pharma partners to design rapidly-scalable drug delivery systems, and assist in manufacturing those devices at their facilities or a trusted CMO/CDMO.
Chapter 8: Low Particulates Using Blow-Fill-Seal
Chapter 7: Reliable Aseptic Filling
Chapter 6: Advantages of Blow-Fill-Seal
Chapter 5: Suitable Drug Products for BFS
Chapter 4: Types of BFS Machines
Chapter 3: How Blow-Fill-Seal Works
Chapter 2: Blow-Fill-Seal in Pharma
Chapter 1: What is Blow-Fill-Seal?
Fill-Finish Podcast 1: “Current Trends in Isolation Technology and Vaccine Production”
Participants
Chats with Chaudhrey: “Fareva Licensing Agreement”. Jay Walker
Rizwan chats with Jay, Executive Chairman at ApiJect, to learn more about ApiJect’s recent licensing agreement signed with Fareva to create a France-based 500M unit annual capacity for single-dose pre-filled vaccine injections.
Project Profile: Fareva
Increasing Vaccine Fill-Finish Capacity in France: 500M Unit Annual Capacity for Single-Dose Prefilled Vaccine Injectables
Fierce Pharma: “Next Supply Chain Challenge: Syringes”
An estimated 14 to 19 billion incremental injections will be required by year-end 2022 to vaccinate the world’s population against COVID-19 while supplying related boosters and adjuvants. In response, the industry is shifting billions of syringes from routine vaccinations and therapeutics to COVID, increasing existing capacity, and building new manufacturing sites for syringes. Yet COVID’s supply chain is still expected to fall short. What is the source of this looming shortage? Is “syringe nationalism” causing export embargoes? How is the industry responding? Is it a supply chain problem?
In this webinar, three experts in pharma and global health discuss potential solutions including,
Presenters
What Have Been the Biggest Surprises with COVID-19?
with Ed Kelley, PhD, Chief Global Health Officer
The pandemic’s effects have been far more wide-reaching than many health officials expected, but COVID has also accelerated some positive trends.
Advances in Sterile Liquids Packaging and Form Factors
with Jon Burgess, General Manager, Technology Development Center
Discussion on packaging factors that have led to wider acceptance of Blow-Fill-Seal technology in the pharmaceutical industry.
Strengths of Diversity in Pharma
with Amy Stewart, Chief People Officer
Companies are realizing that a strong commitment to DEI and ESG attracts employees. Word of mouth is very powerful. Companies want to do business with partners that are inclusive with positive values and environmental initiatives.
INTERPHEX Live 2021: “Creating a Sustainable Public Health Supply Chain”
Industry experts share insights on how stakeholders can maintain a robust, resilient supply chain essential to global health and vaccine security, with an accelerated response time to meet the needs of current and future pandemics. The building blocks for this supply chain resiliency include tech transfer, designing for right-size capacity, improving operational efficiencies, implementing state-of-the-art technologies, and establishing regulatory and quality systems.
Presenters
INTERPHEX Live 2021 Session: “Pros and Cons of Global Fill-Finish”
Responding to the COVID-19 pandemic, governments and public health agencies worldwide are developing quality vaccine programs, including local fill-finish capacity, to support global immunization. Yet even before COVID, countries were already facing increased vaccine demand due to population growth. The panel will discuss key challenges and opportunities as governments and pharmaceutical manufacturers seek to establish fill-finish facilities around the world to enable access to greater and more diversified vaccine manufacturing while improving preparedness to respond to future pandemics.
Presenters
Chats with Chaudhrey: “INTERPHEX 2021 Preview”, Josh Myers
Rizwan chats with Josh last week to learn what ApiJect was doing at INTERPHEX 2021. Learn about our Technology Platform that brings together aseptic BFS with connectable components to create high-quality prefilled drug delivery systems.
Single-Dose Drug Delivery Fill-Finish Facility that is Scalable, Flexible, and able to Deliver up to 45M Units Per Month Delivered within an Accelerated Timeline of Fewer Than 7 Months
Part 3
ApiJect committed to creating emergency temporary fill-finish capacity for up to 45M doses a month of a candidate COVID-19 vaccine on BFS lines by the end of 2020. All of these BFS-packaged doses could then be used, if necessary, in ApiJect Prefilled Injectors for scalable, single-dose delivery.
Solving Drug Challenges with Innovation, BFS, and a Technology Platform to Create Drug
Delivery Systems
Part 2
Learn how ApiJect built its Technology Platform around BFS to create innovative drug delivery systems for the prefilled syringe market and other sterile liquid pharmaceutical delivery formats.
BFS and Prefilled Syringes: A Solution for Complex Formulations
Part 1
Many countries, including the US, lack the necessary surge capacity to reliably fill-finish and deliver billions of incremental doses of injectable drugs and vaccines during bio-emergencies.
Chats with Chaudhrey: “Syringe Reuse”, Edward Kelley, PhD
Interesting chat with Edward Kelley, Chief Health Officer, ApiJect, and formerly the Head, Strategic Programs, at the World Health Organization about syringe reuse, the causes, impact, and how to help overcome it.
The Surprising Strengths of Blow-Fill-Seal
with Philip Leslie, Senior Advisor, Manufacturing
Why does the FDA calls BFS an “advanced aseptic process”? How does BFS combine high-speed, economically efficient production with notable manufacturing flexibility? Respected industry veteran Philip Leslie explains “the basics of BFS.”
Project Profile: The RiteDose Corporation
In 2020, as part of the U.S. Government’s COVID-19 response, ApiJect™ entered into a long-term strategic partnership with The Ritedose Corporation (“TRC”). Together, they were able to make operational 45 million units per month of Blow-Fill-Seal fill-finish capacity for America’s COVID-19 response within 7 months out of TRC’s facility in Columbia South Carolina.
Chats with Chaudhrey: “Blow-Fill-Seal”, Philip Leslie
Rizwan chats with Philip to learn more about the advantages and which types of products can be made using BFS.
Chats with Chaudhrey: “How to Progress your Products in BFS”, Philip Leslie
Rizwans chats with Philip to learn more about the advantages and which types of products can be made using BFS.
The ApiJect Story
It turns out that Marc’s solution to the syringe safety problem has the potential to greatly improve how pharma companies fill, finish, and deliver their liquid medicines and vaccines across the board. Read more about Marc’s amazing journey by clicking the button below.
ApiJect Prefilled Injector Assembly
The ApiJect Prefilled Injector brings together an aseptically-filled Blow-Fill-Seal (BFS) container and a pen needle-style Needle Hub* to reliably deliver injectable vaccines and medicines. Click the button below to view the video.
Special Feature: PFS & Parenteral Manufacturing: How COVID-19 Changed the Market
Drug Development & Delivery, Issue: May 2021
Worldwide, the parenteral market is seeing greater emphasis on patient safety. This is driving a strong trend toward unit-dose formats, including Blow-Fill-Seal prefilled syringe, which are now the fastest-growing format for injectables.
BFS Manufacturing Line
What makes BFS truly special is its combination of reliable aseptic filling with its speed and efficiency of production for any size output. In fact, due to its enclosed process and reliability, the industry considers BFS to be an advanced aseptic process. To view the video, click the button below.
The Heat Factor: Part 1 & 2:Why it Matters in Blow-Fill-Seal
with Jeff Price, Consulting Principal BFS Engineer
At ApiJect, our engineers have taken BFS filling enhancements even further by developing proprietary temperature control management methods that can potentially enable many temperature sensitive biologics and vaccines that are not possible on standard BFS lines.