Contract Manufacturing in APAC

An innovative solution provider - Vetter

Peter Soelkner,  Managing Director Vetter Pharma International GmbH, USA

In this executive management interview, Peter Soelkner of Vetter explains the company’s strategy behind its increased APAC presence, offers his insights on the position of the APAC region as compared to other world markets, and discusses the advantages that can result when large pharma and small/emerging biotech companies work together.

1. For our readers’ acquaintance with Vetter, can you briefly discuss what the company does and the service portfolio it offers?

Vetter is a globally operating independent Contract Development and Manufacturing Organization (CDMO) headquartered in Ravensburg, Germany. We are a solution provider to the pharmaceutical and biotech industries and specialise in the clinical development, the aseptic manufacturing, and the final packaging of syringes, cartridges, and vials. Our facilities, located in the US and Europe provide support for early-stage drug products with seamless transfer to our commercial manufacturing for large-scale production.

We have an extensive experience of working with biologics and other complex compounds including monoclonal antibodies, peptides, interferons, and vaccines. As a complete service provider with approximately 3,600 employees, we offer support to our customer’s products throughout their lifecycles from preclinical development through global market supply. Vetter is the originator of dual-chamber technology which enables easier, safer lyophilised drug administration. We are also a leader in the use of RABS technology in clean rooms which mitigates the risk of product contamination throughout the manufacturing process.

As a family owned independent company, we do not manufacture our own drugs but focus solely on our customer’s product success.

2. Two years ago your company announced the opening of a sales office in Singapore which represented your first physical presence in Asia. What was the thinking behind choosing Singapore?

There were a variety of reasons behind our choice of Singapore as our first Asian-based office. Singapore is considered a global biomedical sciences hub, and Asian healthcare market is one of the fastest growing markets worldwide. This market offers great potential for pharmaceutical and biotechnology companies, and as a result also requires the services that a Contract Development and Manufacturing Organization (CDMO) like ours can offer.

Also, an important fact was that a lot of the companies doing business in Asia Pacific (APAC) region are already key customers of Vetter and call Singapore their home. Therefore, choosing this geographic location was an easy decision. Additionally, our choice was underlined by the characteristics of Singapore as a politically neutral, vibrant city with an international airport and convenient location in the heart of the APAC region.

Our experience to date demonstrates that this prime location has only increased awareness of our service portfolio and has improved our access to this promising market. We have every reason to believe that this positive situation will continue into the future.

3. How do you plan on using your presence to take advantage of the Japanese market in the coming years?

Vetter has been working towards a presence in the Japanese market since 2007. In that year, the company was accredited as a foreign manufacturer by Japan’s Ministry for Health, Labor & Welfare, and was given official certification as a unit belonging to the pharmaceutical services segment. The certificate states that the company’s facilities meet the quality and safety standards issued by the Japanese Ministry of Health. Thus, Vetter had been in the position to fill and package drugs for Japanese pharmaceutical and biotech companies for nearly ten years already.

As for the opening of the Tokyo sales subsidiary, our reasoning for this was simple; it means a further expansion into this specific region, and an investment in our future. It was also driven by the demand from our Japanese customers for manufacturing their quality products, and is also in response to a rapidly growing market.

Following the successful implementation of our Singapore hub office, we have continued to target and strengthen our position and highlight our presence in relevant and interesting selected Asia Pacific markets. Japan plays an important role in this approach as the second largest pharmaceutical market for high-value drugs.

4. How would you compare the standing of the APAC region to other world markets today? Do you expect major changes in future years?

The APAC region has had a good deal of pharmaceutical contract manufacturing over the past several years. In this time, we have seen a distinct shift taking place both in the nature and manner of contract manufacturing and how the drug products are distributed. To give you a better idea of this shift, consider that traditionally, medicines that were manufactured in the region were also primarily intended for use within the APAC countries.

Over the past several years we have begun to see strong efforts to enlarge the customer base for medicines manufactured within APAC, through distribution to countries outside of the APAC region. We think that this trend will continue and even increase in the near future. As a result of the opening of this market, we have also seen greater competition among pharmaceutical manufacturers within the region who now face competition from outside the region as well. This change means that manufacturing companies must be able to adapt to differing criteria of the recipient countries. For example, manufacturers must make certain that distinct quality requirements are met for countries located inside, as well as outside, the APAC region.

5. In your opinion, what are the drivers and restraints of pharmaceutical contract manufacturing in APAC region?

Today we are seeing a growing market demand in the APAC region primarily due to a large and growing population which, fortunately, is supported by increased access to medicines. Within the fast growing pharmerging markets, which include China, demand will be driven predominantly by economic gains and rising incomes, particularly for the low income earners. This increased income, coupled with government commitments to support expanded access to basic healthcare services, will make medicines more broadly available and affordable to millions of people. As a result, multinational pharmaceutical companies will have a strong interest in gaining access to the region and engage in building infrastructure.

As for the restraints affecting the market, it must be stated that especially in the injectable market where our company is operating, a significant level of knowledge and longtime experience is required in order to successfully manufacture parenteral drugs. This is due to the complex nature of the compounds themselves as well as their complex handling requirements. Thus the typical cost saving aspect seen in other production services, often an important benefit of goods produced in APAC region, does not have that great effect on injectables.

6. Let us turn now to the challenges the market presents. According to your long-term sales experience, and your recent in-country experience, what are some of the specific challenges in pharmaceutical manufacturing within APAC region? Also, what solutions did Vetter offer to address and solve these challenges?

In general we are speaking about a very broad and fragmented market and as such, experiences a good deal of cultural and technological differences. Thus, it is difficult to answer this question in general terms. The specific nature of the challenge will always depend on the geographical sector where a company is operating. If we are talking about a global market player, for example, the challenges they face along with their partnering companies are more general in nature, for instance, the evolving regulatory requirements, or the increase in costs of drug development.

When we examine the services that Vetter offers to enable a successful navigation through the challenges present in this market, I would like to highlight the following:

• We offer our customers a long-term experience with international regulatory authorities since we have been audited and certified by a variety of agencies including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA) in Japan, China Food and Drug Administration (CFDA), and many others. Currently we manufacture more than 50 customer products with FDA approval; many of them are marketed throughout the world by our customers.

• Our production facilities are designed to meet or exceed stringent cGMP requirements. We are a leader in the use of Restricted Access Barrier Systems (RABS) in cleanrooms which mitigates the risk of contamination by minimising human contact with products during manufacture.

• Because we do not have drug products of our own, we avoid any conflict of interest with our customers.

• Our portfolio spans resources from preclinical development through to global market supply. As a strategic partner this means we can offer services from a single source to support our customers from the early development phases of their drugs, on through to market supply and long-term product lifecycle management for their medicines.

• In summation, as a solution provider we always try our best to be the partner of choice at every stage of a customer`s injectable product lifecycle. It is our goal to grow organically on a long-term basis with our customer base.

7. One often reads about cooperation between established big pharma companies and small or emerging biotech firms. From your CDMO’s point-of-view, can you share your opinion about possible advantages of these cooperations, as well as how service providers like yourself might be able to contribute to such cooperations?

In our experience we find that cooperation between these two types of companies most often results in win-win situations. What we have seen from our role as a CDMO is that a small biotech firm may offer a pipeline with promising drug substances, but lacks the necessary capital to successfully develop the medicines and bring them to the market. Conversely, big pharma companies often have access to the necessary capital, but lack the required pipelines. Thus, the two companies can be very helpful to one another.

CDMOs often act as the ‘builder of bridges’ in such situations. In our daily work with both large pharma companies and small or emerging biotech firms, we have gained good insight into how these companies work and what their specific needs are. We know, for example, what the small company must be thinking about today, because it will be important at a later development process stage if they want to attract a large pharma company interested in acquiring a promising small company. Based on this knowledge and insight, efficient development processes can take place resulting in a greater chance of success for both parties. Just as important, it can mean a quicker availability of important medications.

Company profile

Vetter is a global leader in the fill and finish of aseptically prefilled syringe systems, cartridges and vials. Headquartered in Ravensburg, Germany, with production facilities in Germany and the United States, the Contract Development and Manufacturing Organization (CDMO) is an innovative solution provider serving the top 10 (bio-) pharmaceutical companies, as well as small and midsize companies. Its portfolio spans state-of-the-art manufacturing from early clinical development through commercial filling and final packaging of parenteral drugs. The company’s extensive experience covers a broad range of complex compounds including monoclonal antibodies, peptides and interferons. Vetter supports its customers every step of the way, guiding their products through development, regulatory approval, launch and lifecycle management. Known for quality, the company of approximately 3,600 employees offers a foundation of experience spanning more than 35 years, including dozens of customer product approvals for novel (bio-) pharmaceutical compounds. 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®. Vetter’s branch office in Singapore and its subsidiary in Tokyo, Japan, increased the presence of the company and the awareness of its service portfolio in the Asian healthcare market. Visit:  www.vetter-pharma.com.

AuthorBio

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 organisation. 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.

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Author Bio

Peter Soelkner
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