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Vetter clients can concentrate fully on their core business

The Ravensburg-based company Vetter Pharma-Fertigung GmbH & Co. KG is one of the leaders in biopharmaceutical contract manufacturing. We spoke with Max Horn, who has been with the company since 1981 and was appointed Managing Director in 2002.

Horn studied at the German Academy of Business and Administration in Ravensburg. After graduating, he became Representative Accounting Director; in 1993 he was promoted to Director of Controlling and became a member of the Board of Directors of the Vetter Group in 2000. In the same year, Horn participated in a Senior Executive Programme at the renowned Columbia Business School.

Why do biopharmaceutical or biotech companies outsource production to Contract Manufacturing Organisations (CMO)?

There are several good reasons for biopharmaceutical and biotech companies to work together with contract manufacturers. The companies save a lot of time and money because they do not need to establish their own aseptic filling facilities, nor do they need to focus attention on the know-how required for the production of pharmaceuticals. They buy all this from specialised outsourcing partners and can concentrate their resources on their core activities, namely the research and development of new drugs.

What do you expect CMOs to have and what do you like them to have?

Max Horn, Vetter's Managing Director. (all credits: Vetter Pharma-Fertigung)
Important prerequisites are the CMOs’ technical equipment, quality, know-how and experience. Another important factor, in particular in the pharmaceuticals business, is that outsourcing is a matter of trust and confidence. Pharmaceutical and biotech companies which intend to outsource production must, in terms of quality, be able to rely on their CMO 100 per cent. An absolute must is that the work carried out by the CMO conforms with the regulatory standards that were agreed upon; this is imperative when medicines are produced for a certain marketplace. The ability to work in conformance with the highest quality and safety standards depends on state-of-the-art production plants. Future-proof technologies are the basis for the long-term success of the cooperation with CMOs.

If contract manufacturers possess a broad portfolio of filling facilities for different application systems, this will give pharmaceutical and biotech companies greater flexibility in entering the market and they will later be able to change to application systems of a higher quality. Of major importance is whether the CMO has high standards of production processes and whether it is able to offer innovations in terms of packaging. Contract manufacturers that offer innovations and implement state-of-the-art developments are able to react in a more flexible way to changes in the pharmaceutical and biotech industries.

In addition to these factors, the client is also interested in the know-how and experience of the CMO. What kind of references does the outsourcing partner have? What are the substances and dosage forms the partner has worked with previously? What kind of cooperation is planned? What about integrated project management? What kind of experience and training do the CMO’s employees have? How does the partner work together with the regulatory authorities?

When should a client who is willing to commission a CMO start to look for a suitable partner?

It will take quite some time to find a suitable partner. Enterprises are therefore encouraged to start thinking about outsourcing options and look for suitable candidates as early as possible. This is also important because contract manufacturers are able to provide important support during the early development phases when packaging and processes can be developed and be adapted to subsequent production. This may accelerate market entry.

Vetter Pharma works for international clients and fills substances that are parenterally administered. What kind of drugs and dosage forms are you dealing with?

Parenteral drugs have to be injected rather than swallowed. Because of the chemical structure of these drugs, they would be metabolised or absorbed in the gastrointestinal tract, and so cannot be taken orally. In order to exert their effect, parenteral drugs have to be injected into the veins, arteries, muscle or below the skin using syringes or carpules with pen systems. Vetter has a lot of experience in the field of injection systems. The company supports pharmaceutical and biotech companies in the development phase, works together with its clients on developing a process for commercially producing the drugs and then carries out the filling and final packaging of the drugs into syringes, carpules and vials.

The production of parenteral drugs is regarded as a difficult, even awkward business. Can you explain why?

Vetter
Vetter's lyophilization process: Automated loading of the freezing dryer.
There are particular challenges in the production of parenteral drugs, not only the requirements of the active ingredients themselves, but also the requirements of the regulatory authorities. The active ingredients – and in particular biotechnologically produced ones – are particularly fragile and are very sensitive to environmental influences. In order to fill these substances without interfering with their effectiveness, it is necessary to create environmental conditions that allow us to do so, which means that the highest aseptic cleanroom conditions are necessary. Another aspect why parenteral drug production is often regarded as awkward refers to the strict safety regulations in place as negligence would entail serious dangers to the life of patients.

Why do you think outsourcing of production and filling of parenteral drugs is particularly useful?

The outsourcing of the production of injection medicines is useful because both legal regulations and the substances themselves mean that highest safety and quality standards have to be taken into consideration. Serious financial investments have to be made and a long time is required to establish the know-how and capacities in this field. In view of the increasingly intense competition on the international pharmaceuticals market, pharmaceutical and biotech companies can use their resources more effectively for other things. If CMOs with great experience and state-of-the-art syringe technology take on the production, the outsourcing companies are able to concentrate their money and time on their core activities.

Excellent CMOs must be able to offer basic services such as extensive knowledge in aseptic filling, validation and regulations. Are there other factors that are important?

Aseptic filling of syringes within the framework of clinical study.
Excellent contract manufacturers must not only be filling companies, but must also be able to support their clients from the early stages in the commercial production of drugs. A decisive aspect is the know-how in handling the active ingredients. Today, many substances have a very complicated structure and are very sensitive to environmental effects. Syringes and other packaging as well as manufacturing processes must therefore be adapted to the substances used. This development work not only requires comprehensive knowledge but also great experience. In addition, many substances – in particular those produced biotechnologically – can only be stored over a long time when freeze-dried. Effective CMOs should therefore possess the technical conditions, know-how and methodological abilities for developing suitable packaging and for carrying out production effectively.

A definite plus for CMOs is to offer full service packages. CMOs developing their own innovative and user-friendly administration systems can bring their clients decisive advantages against competitors. They can set themselves apart from other producers by filling their drugs into these syringes or carpules. Patient-friendly dosage forms also enable the companies to tap new market segments, such as the homecare sector. Another important topic of the future is safe drugs. Outsourcing partners might want to come up with solutions that make counterfeiting or the repeated use of application systems difficult or even impossible.

Assuming that the manufacturing capacities and safety aspects are in place, what kind of additional services and packages should the CMOs offer?

Contract manufacturers following success strategies such as time-to-market (TTM) or product life cycle management (PLM) provide their clients with huge advantages in the international market. A TTM strategy will combine several processes associated with the development of packaging and production and run them in parallel. This might reduce the product’s time to market. PLM has to do with the life of a product in the market. For example, the filling of substances into vials enables the products to be launched rapidly. Once the drug has established itself on the market, then the companies might shift to application systems of a higher quality, such as user-friendly syringes. This might help the products to remain on the market for a longer period and allow them to compete more effectively with similar products on the market.

If an international client contacts Vetter in Ravensburg, what does this company expect from you?

Vetter market production: Stopper placement of syringes.
BBiotech and pharmaceutical companies invest a lot of time and money into the development of their drugs. It takes up to twelve years before a substance enters the market as a drug. During this time, the product creates no revenue; nevertheless, there are high costs involved. In order to bring in the investment costs and make profit, safe production conditions are a decisive factor for our clients. Modern, state-of-the-art facilities and highly-qualified personnel are a prerequiste for maintaining reliable production.

Another important aspect is the financial security of our company. We do not develop and invest more than we can afford; we grow along with the market demand. We are an independent service provider and do not produce own drugs. As a result, there are no conflicts of interest with our clients. In terms of reliability, our back-up possibilities play an important role. We have production sites in several independent locations in and around the city of Ravensburg. If required, these production sites can back each other up. This means the best possible reliability in the filling of the drugs.

For which markets are you currently producing?

Vetter is filling client drugs that have been approved by the FDA and other authorities. These drugs are used in many countries all over the world. We offer injection systems such as one-chamber syringes and carpules, as well as our patented double-chamber syringes and carpules in different formats. In addition to these filling systems, we can also fill the drugs into vials. However, I am unable to disclose more information on this. As I said before, in pharmaceutical production, outsourcing is a matter of confidentiality.
The new meanwhile awarded plant at Ravensburg
The new meanwhile awarded plant at Ravensburg's South created 200 new jobs.

Over the last ten years, Vetter has been growing strongly with the biopharmaceuticals market, both in terms of production capacity as well as the number of employees. Market prognoses foresee further growth, which is above the classical pharmaceutical business. Will Vetter continue to grow so rapidly?

Our growth in recent years has been rapid and we are planning to expand further. At present, we are constructing a state-of-the-art facility for final packaging close to our Ravensburg Vetter Sued (RVS) production site. We hope to grow further and will adapt Vetter’s expansion to market requirements.

The interview was carried out by Walter Pytlik, BioRegionUlm
Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/vetter-clients-can-concentrate-fully-on-their-core-business