What are some of the current critical issues facing the industry in regards to parenteral manufacturing?
There has always been a variety of challenges affecting the parenteral manufacturing industry and its participants.
For example, drug substances continue to be more complex. Thus, requirements regarding their development in particular and, in general, their treatment and processing have broadened, as have expectations regarding the flexibility of service providers. These changes affect issues such as flexibility in timing and batch size, which in turn creates greater challenges and requirements for the supply chain management of service providers. Also, regulatory requirements continue to expand. For example, ‘serialization’ as part of reliable ‘track and trace’ models is now being required. And, while regulatory requirements are useful and necessary in order to continously enable the availability of safe drugs, the consequences to the production side means that strong efforts must be applied to quality systems in order to stay ahead of the market.
We expect new issues and challenges to emerge well into the future. That is why the industry must work hard and smart and in a well-orchestrated manner if it wants to continue to be successful. This is even more important for meeting the needs of the patient who is, afterall, at the very core of our reason for being.
When a company is choosing a parenteral manufacturing service provider, what questions should they ask? What qualities and expertise should a parenteral manufacturer have to ensure that their client gets the best quality product?
This is a critical question, particularly for small (bio-)pharmaceutical companies that have one or more drug substances in development. However, it is also essential for larger companies if they maintain a sharp focus on their core competencies such as discovery, development and the marketing of drugs, but not their manufacturing.
When selecting a partner to cover drug product manufacturing, we see four core pillars that are critical to the selection process. They are:
1. Experience. You need to get answers to questions such as:
- How long the service provider has been in business
- How their previous work aligns with your company’s projects
- How extensive their portfolio as a solution provider is in aseptic fill & finish, and if they can support from clinical filling to commercial production as well as lifecycle management activities
- Their depth of knowledge in domestic and, if required, international regulatory requirements
2. Fit. How well do they fit your business model? You must consider:
- Any notable differences in corporate cultures and business models
- If there is a common understanding of quality aspects
- If good project management is a priority of the service provider
3. Corporate stability. You want to establish:
- Whether the service provider can prove independent financial standing
- If they have a history of organic, consistent growth
- What the short and long-term investment program looks like
4. Long-term resources. You have to determine:
- The level of sophistication of their production facilities and technical equipment
- If a well-trained team of scientists and engineers will be handling your project
- If they can provide creative solutions and respond quickly to unexpected changes. For example, can they provide the flexibility that is required especially in development projects?
Take the time to consider the answers to these questions. The partner you choose will strongly influence your company´s future, so choose wisely. As with life, we often have only one opportunity to get it right, so make sure you get this right the first time!
What do you see as the future of parenteral manufacturing?
We are very positive about the future for the business in which we operate.
Robust growth is projected for the future of the injectable market, with biologics being the major reason behind it. The need for patient friendly application systems for self-medication adds further emphasis to this growth. According to IMS Health, in 2015, twenty of the fourty-five FDA approvals, or 44%, were for injectable products. In the near future, ten to fifteen new injectable approvals are expected per year. We see nearly several hundred projects upcoming in different European markets and a similar size for Japan. That number is even significantly larger in the US, which remains the most important injectable market. While the global oral market expects a cumulated annual growth rate (CAGR) of 6.8% until 2020, the increase in the injectable sector is expected to be 9.3% according to a March 2016 Global Data Sales Analytics report. This would result in a sales increase for injectable application systems in 2020 from 43% to 47% market share comparing different routes of administration.
It is intuitive that along with this growth comes significant opportunities for companies that are a part of the contract services sector supporting these (bio-)pharmaceutical companies. Overall, we have experienced a continuous trend of increased budget provided for outsourced (bio-)pharmaceutical manufacturing. According to a 2016 outsourcing survey conducted by Bio Plan Associates, outsourcing was estimated to be 2.3% higher in 2016 as compared to the prior year. The 2016 data was compiled from a respondent rate greater than 74%, which indicates that fill/finish operations, in particular, are part of their outsourcing activities scope.
Increasingly, sponsor companies have come to expect that the partner they choose to work with must be strategic in their efforts, not simply tactical, as they often outsource an entire pipeline of products, not just a single drug project. Of course, this strategy results in even more implications. For example, a demand for attractive cost models from the provider of choice who can successfully contribute to developing, commercializing, and supplying this pipeline of drugs. By working smart, and with a focus on partnership, these parameters can offer a promising perspective for both (bio-)pharmaceutical companies and their strategic partners.
Company profile
Vetter is a global leader in the fill and finish of aseptically prefilled syringe systems, cartridges and vials. Headquartered in Ravensburg, Germany, the company operates production facilities in Germany and the United States, as well as sales offices in Singapore and Tokyo, Japan. The contract development and manufacturing organization (CDMO) is an innovative solution provider serving small, midsize, and the top 10 (bio-)pharmaceutical companies. Its portfolio spans state-of-the-art manufacturing from early clinical development through commercial filling and final packaging of parenteral drugs. Known for quality, the company of approximately 4,100 employees offers a foundation of experience spanning more than 35 years, including dozens of customer product approvals for novel compounds. More than 80% of Vetter’s active projects are biologics, and Vetter currently manufactures five of the world’ top 10. The CDMO is also committed to patient safety and compliance with user friendly solutions such as Vetter-Ject®, as well as its dual-chamber syringe Vetter Lyo-Ject® and cartridge system V-LK®. Visit www.vetter-pharma.com.
Peter Soelkner has been a Managing Director of Vetter Pharma-Fertigung GmbH & Co. KG since June 2008. In 2009, he was also appointed Managing Director of Vetter Pharma International GmbH, the company’s marketing and sales organization. Soelkner graduated from the University of Dortmund, Germany, in 1992 with a degree in chemical engineering and earned an MBA from Columbia University, New York, in 2001. Before joining Vetter, he held positions in Germany and North America at Sartorius AG and Sartorius North America Inc., in R&D, marketing, key account management and general management roles. At Vetter, from 2003 to 2007, Soelkner managed the company’s key account program and global end-to-end supply chain. He left the company for a year to serve as Vice President of global key account management at Sartorius Stedim Biotech (USA), before returning to Vetter in 2008.