Pharma Focus Asia
Klöckner Pentaplast - Pentapharm® alfoil® films

Responding to the Needs of an Evolving Industry

Dan Stefanoiu, Chief Business Officer, Datwyler, Switzerland

In the ever-evolving pharma market, pharmaceutical and medical manufacturers need to be experts in understanding the industry’s challenges and opportunities to meet their customers’ needs. To stay ahead, Datwyler identified three main topics for future development: future health care, patient safety and global leadership. A new health care offering and two new facilities in India and the US support the new strategy.

In today’s competitive healthcare market, pharmaceutical and medical manufacturers rely on partners with a deep understanding of not only the industry’s challenges and requirements, but also of its opportunities and promise for growth. The pharma market is ever-evolving and ever-changing. Companies have the responsibility to provide the appropriate answers to their clients to meet future challenges. Against this background, Datwyler has identified three main topics on top of its agenda: Shaping the future of healthcare, patient safety and global leadership are the foundation of the company’s road map.

New healthcare offering: Improving patients’ lives

Based on this agenda, Datwyler has introduced a new healthcare offering in March 2017 which consists of the three categories Bio Care, Pharma Care and Med Care to better meet customer needs and expectations. The solutions in the Bio Care category are specially developed and manufactured to address the needs of large molecule pharmaceuticals. This applies particularly to highly sensitive drugs such as biosimilars or biologics for which barrier properties alone are no longer enough to meet the packaging needs of the most sensitive pharmaceuticals. Those drugs are at the risk of being rendered ineffective when in contact with extractables and leachables such as subvisible particles in silicone oils. The Pharma Care category is designed to overcome the challenges for small molecule drugs. The elastomer formulations, compounds and coatings offer maximum compatibility with any pharmaceutical, also mitigating silicone related risks as much as possible. The solutions of the Med Care category are designed for medical companies, providing them with highest quality products and eliminating potential regulatory issues. Enhanced machinability and high productivity rates as well as additional backup manufacturing sites ensure a maximum security of supply. Upon request, hydrophobic and hydrophilic silicone oil and chlorination are available as a final treatment, providing medical companies with further options to customize the product they need.

Introducing First Line in key healthcare markets

In an ever-evolving pharma market and industry, quality standards are of the highest importance to meet the demands of the market and for a company to be a reliable partner to customers. The production standard First Line is dedicated to guaranteeing the highest levels of quality and safety for pharmaceutical rubber components. The First Line production operates in a fully integrated Good Manufacturing Practice (GMP) environment using innovative automated processes and conforming to the highest industry standards. Each zone has been meticulously designed and constructed to prevent bio-contamination and is equipped with material airlocks. State-of-the-art pass-through washing equipment has its automatic loading side in one zone and its automatic unloading side in a zone of even higher cleanliness. The new clean room alsoincorporates the latest generation of camera inspection techniques. The entire facility as a whole incorporates rational and lean production flows in accordance with the Six Sigma methodology. The First Line manufacturing concept exceeds the most stringent quality standards of regulatory authorities and is certified to ISO 15378. It is designed to operate under a zero-defect philosophy. The process flow, gowning protocols, personnel and material flow, and state-of-the-art automation all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry.

At present, Datwyler is building two additional facilities with First Line standard in the United States and India. While Datwyler is a global industrial supplier to the healthcare industry, the company also relies on local expertise and facilities to cater to the respective markets. India as a substantial force in the global pharma market offers a perfect opportunity to introduce the First Line manufacturing standard to the global and local market. The new facility in Pune is the company’s commitment to India and the Asian market. Spread over an area of 24,000 m?2;, the facility will be integrated in the existing premise and will start to operate in September 2017. Currently, 290 employees are working in the facility, but staff numbers will rise to a total of 350 employees by the time production starts.

India: the Hotbed of the Asian pharmaceutical market

India’s pharmaceutical and biotech markets continue to grow and evolve rapidly, catering to a global customer base. The country is also being recognized as one of the global manufacturing destinations. India counts the most FDA approved pharmaceutical production facilities in the world after the USA. Manufacturers that provide safe and effective solutions are an integral part of the country’s path towards growing further into a worldwide aligned successful industry.

In the Indian market, Datwyler is presently focusing on high-end rubber formulations for products like plunger stoppers, Lyo, serum and customised rubber stoppers. Thanks to the introducing of the First Line manufacturing concept, the facility will be able to expand its portfolio by the innovative Omni Flex product line to meet the evolving needs in the healthcare market. Within the parenteral packaging industry, market trends indicate a growing demand for fluoropolymer coated elastomeric closures, primarily to mitigate risks related to drug stability and compatibility. For a therapeutic protein, the exact chemical make-up and three-dimensional conformation can influence the efficacy of the drug product. Interactions with leachables, including silicon oil, can present a risk to the safety of therapeutic proteins. Conformational changes, degradation and/or aggregation can lead to the inefficacy or Test immunogenicity of the protein, ultimately impeding or preventing the success of the drug product. Therefore, many manufacturers of biologics or biosimilars are already relying on fluoropolymer coated closure solutions today.

Omni Flex fluoropolymer coated closures not only have barrier properties which enable superior chemical compatibility, but also have the added benefit of eliminating the closure as a source of silicone-oil-based Subvisible Particles (SbVPs). The coating is formed in a two step process. First, the proprietary fluoropolymer film is applied by a tumble spray coating, and second, a post-treatment process provides sufficient thermal energy to bond the coating covalently to the bromobutyl substrate and to form a smooth, continuous fluoropolymer film. Thanks to the line-of-sight nature of the spray coating, the entire plunger surface is covered except for the interior of the plunger-rod cavity. The total coverage by the Omni Flex coating stands in contrast with the partial coverage of most film coatings and therefore offers the benefit of providing a complete barrier. The total coverage of the fixed lubricious coating also eliminates the need for siliconisation of the plunger rills. This eliminates the largest source of subvisible particles and allows Omni Flex coated plungers’ particle levels to be some of the lowest in the industry. In combination with the optimised product design, the elimination of siliconisation results in glide forces for Omni Flex products which are highly consistent down the length of the barrel and from plunger to plunger. Furthermore, the spray-coating process easily lends itself to coating custom designs for innovative drug delivery devices.

The plant in Pune has been delivering commercial supplies to customers worldwide since 2013, including exports to Europe, the USA and South East Asia. However, Datwyler also has a significant market share in India and has been supplying Indian customers from their global plants for the last 20 years. Currently, the company is catering to more than 50 customers in India.

Author Bio

Dan Stefanoiu

Dan Stefanoiu, as a member of the Executive Management, is in charge of global business and customer relations for the Datwyler Sealing Solutions Division. He joined the Division in April 2016. Before joining the Datwyler Group, Dan acted as Director of Sales and Business Development for Dana Corporation. Dan earned a master of engineering degree from the Polytechnical Institute of Bucharest and completed further management studies.

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