PharmaPac UK has Developed into the Vapour Industry
PharmaPac has now developed into a full-service manufacturer, packer and distributor to the vapour industry.
Whenever members of the tobacco industry complain about the increasing restrictions on their products, they should perhaps thank their lucky stars that they are not working in the pharmaceutical or vapour industry. The latter sector is even more highly regulated, with rules covering the entire life cycle of a drug, including physicians, wholesalers, retailers and manufacturers.
Until the early years of the new millennium, the only point of contact between the two sectors was that some pharmaceutical companies provided nicotine-replacement therapy (NRT) products. E-cigarettes brought the industries closer together.
They contributed to the development of NRTs that ranged from purely medicinal devices to a broad range of consumer-friendly alternatives to combustible cigarettes. And their growth rate has been impressive: According to analysts, the global vapour industry market is poised to expand at a compound annual growth rate of around 20.8 per cent over the next decade to reach approximately $61.4 billion by 2025.
One of the players that have been using its pharmaceutical expertise to make an inroad into the vapour industry is U.K.-based contract manufacturer PharmaPac UK. The independent, privately owned company was established following the closure of the Moreton site of global biopharmaceutical manufacturer Bristol-Myers Squibb in 1996.
For two decades, PharmaPac has manufactured, filled and packed tablets, capsules, liquids, powders and gels for global pharmaceutical, consumer healthcare and nutraceutical companies.
“Five years ago, we saw the emerging vaping industry and recognized the need for a truly world-class quality contract manufacturer,” says PharmaPac CEO John Pugh. Unlike many other players in this field who focus exclusively on e-liquid manufacturer, PharmaPac offers a comprehensive portfolio to the vapour sector.
“We started working with our customers, using our experience to bring a wide range of contract manufacturing and packing services to this market, such as bulk liquids compliant with the European Union’s revised Tobacco Products Directive [TPD2], 10 mL bottles, closed-system devices, pod systems, gum and medical devices. However, our approach and wider experience enable us to offer a truly unique service to support our customers in development, pilot and full commercial realization from small to large global volumes.”
PharmaPac operates from modern, current good manufacturing practices (cGMP) compliant production and storage facility that covers 140,000 square feet (13006.43 square meters) across 11 units in a secure business park outside Liverpool. More than 300 GMP-trained production and manufacturing staff members work in 24/7 shift patterns on 24 production lines and three manufacturing suites.
The company holds a number of accreditation’s, among them a U.K. Medicines and Healthcare products Regulatory Agency (MHRA) license and ISO 13485 medical device certification. The site is also U.S. Food and Drug Administration-registered.
“As an MHRA license holder, PharmaPac has always approached its work in this segment with a focus on quality and the continuing desire to meet its customers’ needs in this ever-changing industry,” says Pugh.
“As wider regulations and product extensions have been introduced, PharmaPac has been well-placed to meet these changing needs for its customers due to its experience in handling multiple manufacturing, filling and packaging formats in regulated industries such as pharmaceuticals and medical devices.”
Meanwhile, services for the vapour sector have developed into an important pillar of the company’s business. Recently, a new division called PharmaPac Ventures was created, dedicated to the communication of the company’s U.K. GMP contract manufacturing facility specifically to the vapour industry.
“We have a clear focus on providing a quality turnkey solution to our customers focusing on but not limited to electronic cigarettes, NRT and novel nicotine-delivery technology industries” Pugh explains.
“Our mission is ultimately to future-proof the tobacco harm reduction industry. We want to support public health bodies, regulators and our customers to ensure that the alternative therapies and products created to reduce the harm associated with tobacco are developed and manufactured to pharmaceutical standards. Only by providing a high-quality product can we give our customers a guarantee of safety and the confidence to design and offer a wider range of products for end users.”
Much emphasis is being put on the continuing qualification of employees, he adds. “Our people are placed at the very heart of the business. We have continued to invest in education and training of our colleagues to stay at the forefront of our service provision.”
“Our experience and time spent working in this industry has not only meant that we have been fortunate to create and develop key strategic partnerships with our customers but also helped us to understand this supply chain, ranging from licensed laboratories, testing houses, bulk material suppliers, packaging suppliers, engineering and machinery specialists, regulatory bodies and much more.”
As a result of the experience gained through its collaboration with the vapour industry, PharmaPac has developed solutions that range from new product development and pilot projects to commercialization and worldwide distribution.
A supply chain and manufacturing plan, a manufacturing process optimization or a quality audit on suppliers are just as much part of the service offering as commercial manufacturing or warehouse storage in an MHRA approved facility. Customers can enter the process at any point, depending on their requirements.
“We have been working with small to large companies internationally for the past five years on projects that have required different levels of expertise across our quality, engineering and commercial teams,” says Pugh.
“We have proven that PharmaPac can deliver any project from conceptualization through to full commercial launch across multiple markets. It is this flexibility and scalability that has been so critical to our success with our partners.”
The company is also investing in a full enterprise resource planning (ERP) system enabling its customers to empower PharmaPac to handle the entire supply chain of the product and be the full-service offering that most companies require, Pugh states. “We become an inseparable extension of our customer’s supply chain and take great pride in playing a major role in our customer’s business.”
Quality is given top priority in all of PharmaPac’s endeavours. “We have a quality management system and ERP system which supports the business to remain compliant in an ever-changing regulatory environment,” says Pugh.
“We think this level of attention to quality is what sets us apart from our competition and mitigates problems with the supply chain further down the line.”
“Our quality team is involved in all projects from initiation to ensure that quality requirements are considered as early as possible to optimize processes and required documentation to minimize delays in project delivery. This allows planning for appropriate controls and measures in order for you to have confidence in the quality and compliance of your delivered product. As we are fundamentally a pharmaceutical turnkey contract manufacturer, everything we do has to come from a position of integrity and be ethical.”
Wanted: More clarity
Pugh considers the vapour industry exciting to work in. It has a diverse number of players with differing objectives, regulatory amendments and continuing innovations in nicotine-delivery systems and substrates used in them.
“Trends are changing at different rates in different markets due to science, regulation and innovative product offerings as alternatives for combustibles,” he says. The U.K., mainland Europe and the U.S. hold the most promising business opportunities for his company, he adds.
“It is disappointing to know that many consumer research surveys still show that a large proportion of smokers believe the use of using alternative nicotine-delivery products is equal to if not worse than smoking traditional combustibles,” Pugh concludes.
“There needs to be a significant education piece in all markets to highlight that this is just not the case. It is clear that some markets are ahead of the game in this area, thankfully. The U.K. public health organizations have made significant strides in changing these perceptions, and we need to continue this globally.”
“It is also clear that more research and evidence is starting to come to the fore, and this has to be a welcome addition to the discussion and should enable better choices by regulatory bodies, public health organizations, brand owners and also consumers.”
If you’d like to learn more about how your business can benefit from the services provided by PharmaPac Ventures, please contact a member of our team today.