It’s all about teamwork, collaboration, and Quality
PharmaJet has expanded its manufacturing capacity to meet the increasing demand as our partners commercialize their vaccines and pharmaceutical products. Read more below about the extraordinary effort and commitment our Quality and Operations teams and our collaborators demonstrated to increase manufacturing capacity amidst the backdrop of the 2021 global supply chain turmoil.
Global scale-up in record time
How did PharmaJet support the commercial launch of a COVID-19 vaccine against all odds during a pandemic? According to Meghan Long, Director of Global Program Management at PharmaJet, “As a small company, we operated very efficiently and built our contract manufacturing partnerships to deliver on programs with high quality, quick delivery, fast scale-up, large volumes, low waste, and always, the highest levels of collaboration. PharmaJet worked side-by-side with its domestic and international manufacturing plants to keep production moving 24/7.”
Well before our vaccine partner, Zydus Lifesciences, received Emergency Use Authorization (EUA) for their DNA Covid-19 vaccine, delivered exclusively with the PharmaJet Tropis® System, a significant scale-up in our production was already implemented to prepare for commercialization. The PharmaJet team rose to the challenge with relentless around-the-clock support from both the Quality and Operations teams, who collaboratively increased capacity for Tropis Syringe Assemblies from 9 million annually to nearly 45 million! Additionally, we increased our production tooling capacity to support component sets volume of up to 337 million a year. Within four months of kicking off the manufacturing expansion we increased injection molding capacity by 600% and continued to grow from there.
Quality, our top priority
We achieved our manufacturing expansion by leveraging proven, high efficiency manufacturing processes, and partnering with the right contract manufacturers. When first selecting our manufacturing partners and throughout production and commercial manufacturing, we put the highest emphasis on quality. According to Stephan Jones, PharmaJet’s Director of Quality, “We dedicated significant resources to the supplier selection process, so that once production kicked off, we had trusted partners who aligned with our goals and had the resiliency to tackle challenges as they arose. Our aim was and continues to be to ensure our customers have worry-free and unwavering long-term support, so we require on-time delivery to the highest quality and business standards.”
Focused teamwork overcomes challenges
Managing through unexpected challenges is what distinguishes PharmaJet as a reliable partner. According to Troy Chapman, Director of Operations at PharmaJet, “Anticipating and overcoming roadblocks with a “get it done right” mindset is well-established in the PharmaJet culture. This cultivates a high-level of pride and care that each employee takes in their work. Our jobs are really rewarding when we see how we influence customer success and how we contribute to the global impact in addressing the pandemic and other infectious diseases.”
As a solutions provider we want to make it easy for customers to source our Needle-free Injection Systems whenever they need them. Underlying that ability is our resilient, flexible, and efficient supply system that ensured product availability consistently, despite the obstacles faced during the 2021 global supply chain turmoil. Troy continued, “With the Covid-19 pandemic, everything became incomparably harder as it brought about a whole chain of unprecedented supply challenges which our team systematically overcame.” These included:
- Sourcing raw materials – We worked directly with our contract manufacturers and resin suppliers to source and expedite materials even when they seemed unavailable. Our team built strong relationships directly with resin suppliers, and for additional supply security, we identified and validated alternative materials.
- Shipping delays – With fluctuations in global supply chains, transit times were intermittently longer than normal. Our team rigorously evaluated transit partners and delivery options to minimize logistical delays and impact on our customers.
- Personnel shortages – Everyone knows that COVID-19 created work shortages in every industry. The PharmaJet team and our CMO partners worked extended hours to cover for each other in multiple roles and wore many hats when colleagues took care of sick family members and navigated remote schooling for their children. The Operations and Quality teams constantly re-balanced roles and priorities to adjust as needed. Everyone, even the Executive Leaders, took a hands-on approach to driving and tracking the most efficient solutions to the extensive list of problems COVID threw at us.
- Long supplier lead times – We experienced COVID-related delays ranging from components to assembly to packaging and sterilization. PharmaJet negotiated directly with each respective supplier, including third party suppliers, to reduce delays where possible, and we expedited shipments to meet production timelines. Addressing single-source options for critical and long-lead items became our mantra, and directly sourcing materials became an essential part of PharmaJet’s support to our CMO partners. Additionally, we validated suppliers with larger packaging and sterilization capacity, further reducing our delivery timelines for Finished Goods.
When you work with PharmaJet, you can be confident that we provide:
- Global Reach and distribution points: We have international, redundant GMP production with manufacturing, assembly, packaging, and sterilization partners in Singapore, US, and India. This means we can get the product to you quickly and at the best price.
- Highest Quality standards and compliance: Our design control systems are compliant with USFDA 21CFR part 820, Medical Device Directive 93/42/EEC, and ISO 13485 Quality Management Systems for Medical Devices, and we are the first and only needle-free system that has been WHO prequalified.
- Credentials: To support our collaborators, we have established a Device Master File with US FDA. Our devices are CE marked for distribution in the European Union and we have Tropis device registrations in Brazil, Vietnam, Israel, India, Kenya, and Ghana.
- Resilience: No excuses! We have delivered for our customers through the COVID crisis and the associated supply chain turmoil. We will do the same, again, for you!