By progressing from a contract manufacturer to a full-service provider, Sandoz has become one of the world's leading creators of advanced biotechnological products. World Pharmaceutical Frontiers talks to Friedrich Nachtmann, the company's head of biotech cooperations, about scaleable solutions in biotech manufacturing.
Friedrich Nachtmann: Sandoz's predecessor was founded in 1946 as a start-up company; its mission was to produce penicillin. Today, Sandoz remains a leading force in the manufacturing of antibiotics.
In 1987 we started to develop and create modern biotechnology products. At first, we produced a recombinant bovine growth hormone and then, from 1995 onwards, we laid out a strategy to grow our biotechnology arm, and began to enlarge our contract business with the addition of microbial products. In 2003, we also moved into mammalian cell culture. We currently use both sides for development, and manufacture not only for our contract business, but also for our own biosimilars.
We've been reacting to market needs and building up our capabilities. We started out as a contract manufacturer of solely microbial active pharmaceutical ingredients (APIs), before deciding to introduce process development capabilities on site, so we built our labs to accommodate services, from cloning through to downstream processing, both at laboratory and pilot scale.
We also invested heavily in our analytical laboratories, which are needed for product characterisation and are extremely important for our biosimilars development programme. Then, taking into account the rise of monoclonal antibodies, we initiated an investment programme into mammalian cell culture.
This involved an approach similar to developing microbials - we back-integrated our capabilities from early development through to cell line optimisation, fermentation and downstream, at lab and pilot scale.
But it still wasn't enough; at the end of the process the APIs manufactured must go through a number of registration procedures, so we added to our regulatory support functions. We now offer this service to all of our clients.
We believe that an effective tech transfer is the basis for successful manufacturing. We've developed a standardised programme that is laid out in several phases: feasibility studies, transfer of all the important analytical methods, transfer of the manufacturing process at laboratory or pilot scale and upscaling to our facility.
We have the advantage of two separate microbial and mammalian manufacturing sites; our flexible pilot plants can mimic the large scale and undertake the necessary process adaptation or optimisation. Depending on the process and data, we have timelines of around six to eight months for a complete tech transfer. We like to emphasise the importance of good planning and realistic time horizons.
You have to identify the customers' key parameters. The process needs to fit the facilities you have in order to successfully run the project. After all, to get the product approved and on the market, quality matters. Regulatory compliance is also important - you must make sure that you are compliant with authorities' regulations.
We have the facilities to do this and we're approved by all major health authorities including those of the EU and the US. Our average manufacturing performance success rate is more than 95%, so we have the proven experience and track record to deliver.
Finally, good customer relations are key; we have an excellent project management team with dedicated managers for each customer. Professional technical teams are also available on a project-by-project basis, where good communication with the customer is guaranteed.
