The year is 2030, a new variant of the latest virus-X is highly contagious and circulating globally. Alexa has just notified you that your custom-made vaccine strips have been dispatched and will arrive today between 9 and 9:15 a.m.
You can even track the progress of its journey via the fully automated, electric, carbon-neutral delivery craft. When it arrives, and the robotically operated delivery pod drops it at your doorstep, you receive a second notification requesting that you verify delivery by scanning the unique digital fingerprint on your precious package. Upon scanning, your phone starts playing a 30-second instruction video, in the language of your choice, so that you can immediately self-administer the vaccine. Then, with a sigh of relief, you continue your day’s activities, knowing you can soon have the confidence to go about your normal life again.
Many may believe this to be the opening scene of a sci-fi movie, but if we look at history and realize the rapid pace of evolving technologies and our ever-expanding capabilities, then actually this is not far from our soon-to-be reality.
The COVID-19 global pandemic has irreversibly changed our world, and the social, economic and public health effects will be with us for many years to come. Pharma and biotech are urgently developing and testing vaccines at an unprecedented rate. According to the most recent information from the coronavirus vaccine tracker, (accessed on 06 October 2021), 134 are in clinical trials, with 35 in the final stages of testing.
Besides this, at least 75 vaccine candidates are under active preclinical investigation in animals.
The current world population is just under 8 billion, and since vaccine rollout began (i.e. Nov 2020) approximately a 7.3billion doses have been produced worldwide with a total monthly production for September 2021 of 1.58 billion. The demand is immense, and pharma/biotech, together with the contract development and manufacturing organizations (CDMOs) that keep them functional, are under pressure to deliver at these massive scales.
Once the vaccines are manufactured, the next steps of fill/finish and distribution are crucial to get the products to patients for both clinical trials and commercial use. Ensuring adequate capacity and the supply of materials for packaging are of critical importance in the race to develop vaccines. CDMOs are essential to handling the expected surge of capacity needed, and several have announced manufacturing agreements and capacity expansions to meet the current demand for COVID-19 vaccines. Packaging any product is a multifaceted process and becomes even more complex when the product is a vaccine with specific storage conditions and limited shelf life.
“It’s all about understanding the constraints and parameters of what is required to package a vaccine, with storage conditions being a paramount factor of consideration,” said Alex Weaver, Director of Engineering, Pharma Services PCI.
Cold chain distribution of vaccines urgently and at large scale is a new challenge, especially when each vaccine comes with its own specifications. As of October 2021, the top 5 vaccines that have been manufactured globally already have three different cold chain storage and distribution requirements:
- Pfizer/BioNTech at minus 70 degrees Celsius,
- Moderna at minus 20 C,
- AstraZeneca and Sinovac and Sinopharm at 2 to 8 C.
Weaver explained that having the necessary infrastructure could be a major challenge.
“Adding additional cold storage space to meet the market need to handle the high volumes of COVID-19 vaccines requires a lot of equipment. The market is strained at the moment, especially as the pandemic has been prolonged, and the idea of what business is essential or not becomes an issue because eventually, if you go further and far enough down the supply chain, every business is essential.”
Executing high-volume projects with extremely short timelines is a challenge in today’s market. The difference of a week’s delay can mean huge financial losses and, added to that, the potential of thousands of lives lost when it comes to COVID-19 vaccines. High-volume projects mean that lots of data and establishing unique and secure network connections for handling high data volumes are critical. Each time a new customer comes on board and requires packaging services from a CDMO, there is a huge exchange of data between the two companies to achieve this. This is no simple task, and when done correctly, a secure business connection needs a significant amount of time to establish.
The custom-made or bespoke data connections from the manufacturer to the packager are extremely important to protect each customer, explained Ray Hook, Director of Global Serialization, PCI. The time investment needed to provide these bespoke connections is challenging, and when you’re on an accelerated timeline, that is the critical aspect.
End-to-end security of the supply chain is critical for providing patients with safe and effective vaccines. COVID-19 vaccines are already showing up on the dark web at exorbitant prices. Also, there are reports of hackers trying to break the supply chain and a global phishing campaign that is systematically targeting companies involved in the so-called COVID-19 “cold chain.”
Counterfeiters are getting more intelligent about what they do; they can copy a serialized label and make the stock look exactly the same as the original product. Investing in anti-counterfeiting technology and systems is important for sponsors and CDMOs to beat the individuals who take advantage of breaks in the current systems,
Current and Future Trends
Generation Z is the first generation of true digital natives, born 1995 to 2009, and these consumers demand a high level of quality from products they buy, setting the bar even higher than their predecessors, the millennials. Next is Generation Alpha, those born after 2010, and by the time they become young adults, the landscape will have likely changed so drastically that we cannot fathom it. The trends we see now are leading to a totally autonomous and remote way for patients to receive therapies and use self-administration and self-monitoring all while in the comfort of their homes. The pharma and biotech companies, and their CDMO partners that are tech-savvy and forward-thinking, will excel in this arena.
A focus on patient centricity and cutting-edge technologies will continue to be important for today’s and tomorrow’s consumers. Direct-to-patient or decentralized-model adoption, self-administration and wearables increase patient centricity, while the use of cutting-edge technologies, such as augmented reality and virtual reality, will undoubtedly improve the patient experience.
Packaging providers must learn to accept uncertainty and be flexible. Uncertainty is likely to persist as additional vaccines with potentially more attractive features, such as improved thermostability and single-dose requirements, are developed.
Flexibility in packaging configuration to increase the speed of vaccine supply to patients is a current trend pointed out by Weaver.
“The multiple-up versus the one-up configuration for packing cartons is a trend that the industry will continue to adopt”
A major consideration currently and in the future will be ensuring that the vaccines reaching patients are genuine and trackable. Serialization and anti-counterfeiting are the processes during packaging that ensure this. However, serialization standards differ greatly from country to country, with varying degrees of complexity.
Hook predicted that a global standard for serialization will emerge over the next few years. Another trend Hook pointed out is that the global pharmaceutical market is moving toward requiring aggregation in the serialization process, because adding aggregation data significantly increases the traceability of a product.
“PCI has invested the time and the effort to have aggregation already built into all of their lines”
This gives PCI a competitive advantage over other CDMOs, which are most likely doing the bare minimum to meet the current serialization regulations.
Every large corporation within pharma and biotech has a responsibility to the environment, and sustainability is an integral part of that identity. Implementing eco-friendly processes that reduce the carbon footprint on our fragile environment is a trend in packaging that will continue to expand in the future. The use of more recycled materials and reusing more package components will continue to grow together with the discovery of innovative environmentally friendly processes.
Choosing the right CDMO partner
Imagine the scenario: After pumping hundreds of millions into R&D and clinical trials, the vaccine is finally ready for commercialization. Senior management is keen to find a CDMO that it can trust to handle the high-priority and high-volume product. With so many CDMOs servicing pharma and biotech, deciding whom to partner with becomes a conundrum. Unfortunately, there is no universal magic formula, but a list of desirable attributes should inevitably be considered.
Desirable attributes to look for in your CDMO Partner:
- Resourcefulness and flexibility
- Protecting your brand
- Establish trust
- Alignment of corporate culture
- Aiming for excellence
- Ability to perform under pressure
- Experience and track record
Success story from Alex Weaver:
PCI was given the task to commission a whole new line from PO to commercial launch in order to supply a pediatric vaccine within six months. This was an extremely tight timeline because it can sometimes take six to nine months to procure the equipment alone. The project was even given a code name after Olympic sprinter Usain Bolt. PCI worked across all its sites, repurposed equipment and worked closely with the customer to expedite all processes.
“We put our best resources on it and worked with a belief and purpose that we were going to get it done, and we did it”
Flexibility can mean planning projects in parallel, with potential revisions made as assumptions change or uncertainties are managed. Nicolette Louissaint, executive director of Healthcare Ready, was recently quoted in an interview by Supply Chain Dive1 where she highlighted the importance of being flexible and nimble.
“It’s often more about having capacity that can be adjusted and can be nimble, rather than focusing on a specific type of product”
One of the critical strengths that PCI possesses is its standardization and built-in redundancy. “PCI has the ability to package the same product on multiple production lines, therefore increasing output volume and speed, allowing flexibility with the ability to ramp up and scale down production according to the demand,” Weaver said. Secure serialization and anti-counterfeiting systems are the keys to ensuring brand protection.
“Protecting brands will burnish a type of customer loyalty, which is priceless as it gives you a sense of security,” Williams said. Establishing trust between the customer and the packaging CDMO makes the relationship better for everyone. “Our customers are ultimately more confident, and they trust in our processes. And when you trust in the process, it ultimately creates a better relationship between you and whomever else you’re working with”
Striving to be the best at what you do should always be the goal. PCI has made a large investment in its capabilities for packaging prefilled syringes, autoinjectors and vials, which are the three primary delivery formats for biological drugs.
“Our ability to package these specific types of medicines, coupled with decades of experience, makes PCI the biotech center of excellence for pharmaceutical packaging in the world”
Wartime tactics are needed when dealing with a global pandemic. Adopting a sense of urgency and using audacious approaches, from spending billions on untested technologies to compressing clinical trials from years to months, are required to get our world back to some sense of normalcy. Ben Hubbard2, CEO and co-founder of Parsyl, warns that unless we bring the same kind of urgency, inventiveness, and investment to cold chain management and vaccine distribution as we have to vaccine development, our attempts to end the COVID-19 pandemic will fail. Intrepid and successful CDMOs are and will continue to evolve from pure packaging and distribution partners into cutting-edge service providers focused on customer experience and service and, consequently, true added-value partners.
¹ https://www.supplychaindive.com/news/coronavirus-vaccine-supply-chain/579835/
² https://fortune.com/2020/09/17/covid-vaccine-distribution-cold-chain/
The global healthcare industry trusts PCI for the drug development solutions that increase their products’ speed to market and opportunities for commercial success. Only PCI brings the proven experience that comes with more than 50 successful product launches a year and over five decades in the healthcare business. Leading technology and continued investment enable us to address global development needs throughout the product life cycle — from Phase I Clinical trials through commercialization and ongoing supply. Our clients view us as an extension of their business and a collaborative partner, with the shared goal of improving patients’ lives.
We are committed to supporting clients at every stage of the manufacturing cycle, delivering best-in-class services efficiently and effectively.
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