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Biologics earmarked as opportunity in pharma packaging and drug delivery
The pharma packaging and drug delivery industry has gone through many evolutions, most notably to meet the challenges posed by the COVID-19 pandemic over the last two years. Disruptions to global supply chains posed a major issue, combined with a sharp acceleration in digital adoption. Now the sector is coming out the other side and innovating to meet future demand.
To get a sense of where the industry stands, CPHI spoke to Marie-Liesse Le Corfec, Global Portfolio and Product Marketing Director at BD Medical - Pharmaceutical Systems. She tells us about successfully navigating the pandemic, mitigating supply chain risk and the opportunities presented by the biologics landscape.
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What are some of the biggest challenges the packaging and drug delivery industry faces today?
The greatest challenge and opportunity that propels us is evolution of the biologics landscape.
Biologic therapies that are in development now to treat chronic diseases or cancers are raising the bar for injection technologies. With the increasing high dosage, high volume, high viscosity formulations in development, these can create usability challenges due to factors including user capabilities, injection time and force requirements. It’s an exciting time for the industry and BD is integrating all these dynamically changing needs and requirements into our portfolio of high volume, high viscosity solutions for biologic therapies while delivering on the reliability and positive user experiences that are demanded by our customers and patients.
We also observed that the advent of COVID-19 brought a massive shift towards telehealth and telemedicine favouring at-home care and self-injection, accelerating the interest in shifting formulations from IV to SC injection routes.
It also accelerated the revolution of mRNA technologies, bringing with it the need for containers that can support highly sensitive compounds, including the ability to handle deep-freezing temperatures for stability.
Where do you see the most innovation happening in the sector?
The packaging and drug delivery sector has been subject to great energy and change since 2020. With the push of the recent pandemic and the emerging market trends on digital, we see a lot of activity in a handful of key directions.
Sustainability: As a consequence of increased regulations and public awareness around climate change and the impact of healthcare-related waste, there has been a strong push towards more sustainable drug delivery devices, manufacturing and logistic processes. As an example, identifying ways to impact carbon footprint of our end-to-end operations is becoming state of the art and systematically integrated from the product design phases.
Industry 4.0: To assist increasingly stringent manufacturing lines quality controls and audits while enhancing productivity, we see a growing interest in syringe-specific traceability solutions integrating in broader Pharma 4.0. systems. Typical needs are anti mix-up controls, support to reconciliation or root-cause analysis, monitoring of time out of the cold chain, and manufacturing data integration into machine learning systems.
Digital and connectivity: Digital capabilities are spreading their reach into drug-delivery devices: connected hardware (PFS, Autoinjectors, Wearables Injectors,) as well as on the software and apps side to gather injection data and ensure patients receive the right treatment, improving patient adherence and end-to-end traceability.
Alternative routes of administration: The COVID pandemic has dramatically accelerated research and advancement of alternative ways to administer vaccines and biologics. Public and private investment pushed the development of new solutions - nasal and transdermal devices being the most active areas - with many new solutions being developed and launched in clinical trials.
How is BD driving patient centricity? Can you share examples of product solutions transforming the user experience?
Innovation in drug delivery devices has empowered patients to self-administer injectable medications safely and cost-effectively in the comfort of their own homes.
Since 2010, BD Medical - Pharmaceutical Systems has conducted more than 80 human factor studies to ensure usability of our drug delivery solutions for the patient. Our diverse portfolio features the market leading prefilled syringes for convenient administration of injectable or nasal vaccines, as well as integrated devices and systems that can deliver biologics across a wide range of volume and viscosity levels to help treat chronic conditions.
As an example, BD NeopakTM XtraFlowTM glass Prefillable Syringe includes an advanced needle technology for an improved patient experience when administering high viscosity / high volume drugs. With a shorter 8 mm needle and thinner wall canula technology, these syringes may help reduce pain perception and the risks due to intramuscular injection.
BD LibertasTM Wearable Injector is designed to deliver subcutaneous injections of large volume (2-5mL or 5-10mL) and/or high viscosity (up to 50cP) fixed dose biologics for the non-acute setting. BD conducted a 52-subject human clinical trial with the BD Libertas™ Wearable Injector that evaluated the performance of the 5 mL device, including tissue effects, tolerance (pain) and patient acceptance.
How do you balance the need to respond to a crisis like COVID-19 rapidly while at the same time keeping a long-term, resilient course?
The huge demand for COVID-19 vaccines emphasised the importance of supply chains and their security. Short supply chains, double-sourcing and long-term supply agreements have become critical components of supply chain reliability. More product also needs to be stocked and available for fast shipping in large quantities.
Being the largest manufacturer of PFS worldwide, BD supplies all large vaccine companies with billions of syringes and injection device components.
We are investing $1.2 billion over a four-year period to expand and upgrade manufacturing capacity and technology for PFS and Advanced Drug Delivery Systems across our six global manufacturing locations and to add a new manufacturing facility in Spain. The investment is also funding capacity expansion, new product innovations, manufacturing technology enhancements and business continuity improvements across BD’s existing network. These initiatives are all designed to maximize supply and reduce risks for pharmaceutical companies that rely on ready-to-fill syringes for their injectable drugs – including complex biologics, vaccines and small molecules.
How has the digital transformation of the industry changed since COVID-19? What changes accelerated when the pandemic hit, and how did BD adjust?
While Pharma 4.0. technologies were expanding already before the pandemic, including in sterile manufacturing, we are witnessing an acceleration of projects. We believe the solutions we are developing to track and trace containers at the unit level can play a pivotal role in enhancing productivity and quality processes.
On the drug delivery end, the COVID-19 pandemic brought a strong acceleration to changes that were just beginning to emerge in the previous years. Multiple market trends converged towards an increased focus on patient convenience and shift of care settings out of hospitals. The best examples of this acceleration are the amplified use of digital technology in the industry to provide access to care via telemedicine, the development of decentralized clinical trials and the appearance of numerous new drug delivery devices integrating remote data acquisition capabilities.
Customers are showing increased interest in connected devices. BD Medical – Pharmaceutical Systems has been driving open discourse with customers to explore needs and preferences for connected drug delivery. We are actively working to develop drug delivery devices with integrated injection-related data acquisition capabilities. Foreseen benefits of these solutions include increased clinical trial efficiencies (in particular, the automatic capture of accurate and reliable injection-related data regardless of the location of the participant at the time of injection), medication adherence and remote healthcare monitoring. While our digital roadmap is evolving, we continue to progress to meet coming market requirements.
How do you get in front of potential supply-chain challenges?
Since the beginning of the pandemic BD has had a positive track record of being able to mitigate risks linked to Covid impact and to continue to supply our partners.
The series of supply chain crises the industry faced and is facing were an opportunity to further sharpen our supply chain function into a core competency with impact. We have been successful at protecting our customers, achieving zero line stops during the pandemic, and are very confident that we can continue to do so.
Some of the interventions we implemented to mitigate supply chain risk include placing orders with our suppliers 24 to 36 months out to secure our place in line, increasing regional sourcing, leveraging the central role of BD in healthcare to prioritize shipments with national authorities’ support, and using tools to monitor various material categories daily, which allowed us to react quickly to any risk identified throughout our supply chain.
As mentioned, BD Medical - Pharmaceutical Systems is investing $1.2 billion over a four-year period to expand and upgrade manufacturing capacity and technology for PFS and secondary packaging across our six global manufacturing locations and add a new manufacturing facility in Spain.
This investment will reduce supply chain risk to our pharmaceutical company customers and enable an agile supply chain to support our customers’ needs for increased demand in this highly dynamic market. For example, this investment positions BD to have the needed surge capacity for increased pre-fillable syringe demand during times of pandemic response or periods of significant growth of new injectable drugs and vaccines.
What are BD's main priorities and aspirations looking ahead?
With an expanding portfolio of containers, secondary devices and services, BD Medical - Pharmaceutical Systems is committed to drug delivery excellence across the therapeutic areas we serve and to supporting our customers in maximising efficiency in manufacturing operations and combination product development. We are passionate about partnering with pharmaceutical and biotech companies to help achieve their goals with a broad range of drug delivery solutions and services. We are focused on exceeding the demands of the current pre-fillable syringe market through significant capacity investments, while delivering meaningful innovations that address new therapies and drug delivery needs, such as high volume and high viscosity drugs, in the rapidly changing healthcare environment.
What does Pharmapack Europe mean to you?
Pharmapack is an important forum for leaders in packaging and drug development to come together and discuss challenges and innovations in the development and delivery of drugs. For BD, Pharmapack provides an opportunity to share scientific insights and data pertaining to our robust primary container and secondary devices as well as our services, to help de-risk the development process and enhance operations for our pharmaceutical and biotech customers.
How would you describe the future of BD in one sentence?
At BD we continue our relentless commitment to a promising future by developing technologies, services and products so we can help the healthcare community improve safety and increase efficiency, with the ultimate goal of advancing the world of healthTM .
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