Pharma Focus Asia
Klöckner Pentaplast - Pentapharm® alfoil® films

The Asian Healthcare Market

Rapid growth and accompanying increasing regulations lead to the need for serialisation

Bernd Stauss, Senior Vice President Production/Engineering, Vetter, Germany

The Asian market is growing rapidly, and along with this expansion comes the issue of drug counterfeiting. Bernd offers his insight into the key trends affecting this market and what regulatory authorities are expecting manufacturers to do to combat this dangerous and costly problem.

1. Can you briefly inform us what your company does and what its service portfolio offers?

Vetter is an independent, globally operating Contract Development and Manufacturing Organisation (CDMO). As a solution provider to the pharmaceutical and biotech industry, we specialise in the development, aseptic manufacturing and final packaging of prefilled syringes, cartridges, and vials. Our facilities, located in Europe and the US provide support for early stage drug products with seamless transfer to our commercial manufacturing operations for large-scale production.

As a CDMO being in business for more than 35 years, we have extensive experience in working with biologics and other complex compounds including monoclonal antibodies, peptides, interferons, and vaccines. As a full-service provider with approximately 4,100 employees, we offer support to our customer’s products throughout their lifecycles from preclinical development through global market supply. Our in-depth knowledge in development, clinical trial manufacturing, commercial production, lyophilisation, visual inspection, packaging and labelling technologies, provide our customers with a strategic partnership that can accelerate a compound’s success.

2. How important is the Asian pharma and biotech market in general and especially for Vetter?

The Asian healthcare market is one of the fastest growing markets worldwide. As such, it offers significant potential for pharmaceutical and biotechnology companies requiring the services that a CDMO can offer. We have observed a distinct shift taking place both in the nature and manner of contract manufacturing in the region and how products are distributed. There are also strong efforts to enlarge the customer base for medicines manufactured within the Asia Pacific region (APAC) through distribution to customers outside of the APAC region.

If we are going to stay abreast of this market, and take advantage of its growth in the injectable drug market, we need to have an increased presence in this region.

Our response was to strengthen our global position by opening our first sales office in Singapore. We made this choice for a variety of reasons not the least of which is the fact that Singapore is considered a global biomedical sciences hub located in the heart of the APAC region. As such, many of the companies doing business in region are already key customers of Vetter. This makes the choice of the geographic location an easy one for us to make.

Our opening of the Japan office in 2015 further underscores the importance of Japan in particular and the APAC region in general to Vetter. It is important to note that Vetter has been working towards a presence in the Japanese market for many years and has been in the position to fill and package drugs for this market. The growth of the Japanese market is expected to further increase due, in part, to the reforms implemented in 2010. In summation, our increased Asian on-site presence underlines the importance of the APAC region for Vetter’s business activities.

3. Are there any market trends or regulatory challenges which are of high importance for your business?

There are, and will always be, new trends and regulations occurring within the (bio-) pharmaceutical industry. One concerning trend that is affecting the industry as a whole and consequently also our company is drug counterfeiting. This has been a worldwide issue for decades and continues to grow unabated for a variety of reasons including internet sales, unsecured supply chains and minimal punishments. Most importantly, drug counterfeiting puts patient’s lives at risk. For these reasons, regulatory agencies have been seeking and implementing new methods to thwart drug counterfeiters. Serialisation of packaging, which relies on a clear means of authentication and traceability, is today considered to be one of the most popular solutions by many countries.

4. Can you give us greater insight into the important issue of serialisation?

Serialisation involves the process of assigning and applying a unique identification code to a product. The formats of serial number vary widely from global standards to unique versions e.g. in China and Brazil.

The industry uses the term ‘aggregation’ to define the relationship between multiple items within a product shipment, such as cartons, cases, and pallets. Together, serialisation and aggregation form the foundation of ‘Track-and-Trace’ which can document a product’s current and past locations throughout the supply chain. This ability to track a product’s whereabouts and trace its path is the start of a safer and more efficient drug supply chain.

5. How would you describe the current situation regarding the regulations for serialisation?

In 2017, agencies from many countries will be tightening their guidelines in order to fight drug counterfeiting and are relying on serialisation to do so. In some countries like Turkey, India and Argentina, regulators are already demanding that drugs be serialised. The European Union will do so in February 2019. The US Food and Drug Administration (FDA) will make serialisation of drugs a requirement beginning November 2017. Drugs will be given a Global Trade Item Number (GTIN) including the National Drug Code (NDC), a serial number, a batch number, and an expiration date. Because serialisation requirements differ among countries, pharmaceutical and biotech companies must find flexible solutions that can easily adapt to the demands of individual regulatory authorities.

6. How is Vetter preparing for serialisation regulations?

Vetter has been preparing for new regulations for quite some time. In fact, back in 2012 prior to official regulatory guidelines, we established the basis for a serialisation program by doing an initial concept study. We began with a systematic process to evaluate aspects such as: what lines were essential to be upgraded, which suppliers we could work with, the costs involved, and the identification of staff members that should be included as part of the project team. After careful analysis and thoroughly answering of these questions we started our serialisation approach. As part of this project we upgraded our systems and implemented our first pilot line. Today, we are compliant with serialisation requirements for different markets and systematically upgrade further lines.

7. Does Vetter have experience with the implementation of customer projects that involve serialisation?

Because we started preparing for serialisation regulations as early as five years ago, we have been in compliance with serialisation requirements for many markets for quite some time. In 2014, we successfully implemented our IT-solution, and that same year we also announced significant progress in our state-of-the-art engineering solution. After these solutions were implemented, Vetter began offering its customers a range of serialisation services designed to support the prevention of product counterfeiting. In 2015, we reported the first commercial batches for South Korea with single-use identification numbers for one of the world’s leading pharmaceutical companies. We continue to work on and prepare for serialisation requirements in the US scheduled for later this year, and the European Union in February 2019. Additionally, we have already implemented serialisation for other regions of the world such as China, Brazil, Columbia and the Netherlands.

8. It is very interesting, that your first serialisation project was for the Asian market. Which APAC regions already have serialisation requirements and what are the timelines for future regulations of Asian authorities?

Due to the importance of eliminating drug counterfeiting to protect the safety of patients and ensure product integrity,
serialisation is already common across most adopted regulations. This means that by 2019 the majority of the global drug supply will essentially fall under some form of serialisation requirement. India has already implemented serialisation for products manufactured within that country. Other APAC countries with implemented serialisation guidelines are China and South Korea. In South Korea, serialisation requirements have been in place since 2016 and cover 100 per cent of pharmaceutical drug products. The current law now requires companies to serialise drug products. In China, any drug products that are on the Essential Drug List (EDL) must already be serialised. This requirement follows unique requirements in that country for serial number acquisition, serial number and product data formatting, and barcode labelling. It was originally intended that all drug products had to be serialised by the end of 2015. However, China has placed a hold on their serialisation regulation due to difficulties in implementation.

9. What effects do changes in regulatory timelines such as in China have on the development of the serialisation program at Vetter? What is Vetter doing to anticipate and meet the future demands of international serialisation regulations?

The problem of drug counterfeiting is a danger to the industry and patients alike and continues to grow. As previously noted, Vetter has been in the position to support customer and regulatory serialisation demands since quite some time. We already have implemented an IT solution to support serialisation and lines to print and encode serialisation data on packages, as well as the ability to manufacture products that are serialised according to the latest regulatory guidelines. We prepare early in the process, creating partnerships and working as closely as possible with our customers to help ensure that regulatory requirements can be fulfilled according to the defined timeline of the regulatory authority. The investment into serialisation solutions is crucial for the safety of the patient, the integrity of our customer’s products, and to Vetter in its role as a leading CDMO. As such, we will continue to invest in future-oriented techniques and approaches, such as our serialisation program.

10. What are the main aspects Vetter must consider when realizing a successful serialisation project for your customers?

As noted, Vetter takes serialisation seriously and, as such, has a well-defined strategy. For example, we created the position of a Serialisation Process Manager. This function is responsible for certifying that all future requirements arising from different relevant markets will be successfully implemented. We also created a cross-functional team that includes members from departments such as IT, Product and Service Management, Regulatory Affairs, Project Management, Engineering, and Supply Chain. Each member of the team has a strong working knowledge of serialisation, and we continue to make every effort to remain abreast of any new regulatory requirements by building upon the knowledge we have gained in the process. For our customers it is important that we keep their needs in mind, combining the regulatory requirements with their specific ones. The goal is to be as flexible as possible to implement all regulatory and customer requirements alike.

Author Bio

Bernd Stauss

Bernd Stauss was appointed as Senior Vice President Production/Engineering for Vetter in 2014. In this position he is responsible for all Production at Vetter sites as well as Engineering, Technical project management and Technical Services/EHS. Mr. Stauss joined Vetter, a leading contract development and manufacturing organisation (CDMO), in 1994 as a Manager for Validation. He later moved to Vetter’s Langenargen Plant in 1996 as a Manager of Engineering, and in 2002 was elevated to Head of Production/Engineering. In 2003, Mr. Stauss was promoted to the position of Vice President Engineering and in 2007, Vice President Production/Engineering. Mr. Stauss earned his MBA in Business Administration from the University Ludwigsburg in 1989, and a MBA in Pharmaceutical Engineering in 1994 from University Sigmaringen, Germany.

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