Five minutes at CPhI North America with …
Dr Dan Haines, Scientific Advisor – SCHOTT pharma services
PH: Please can you introduce SCHOTT and its presence at this show.
Haines: SCHOTT is an international technology group focussing on specialty glass and materials. For the pharmaceutical industry we produce type-I glass tubing as well as high-quality vials, ampoules, cartridges, and syringes made of tubular glass or polymer. In addition, SCHOTT pharma services performs analytical testing for pharma manufacturers for drug container interaction, extractable & leachable testing and mechanical stability. This analytical business is focused on all around troubleshooting. Are there particulates in the formulation? Where did they come from – the glass manufacturing process, the filling process, the washing process? Are there interactions or precipitates from the drug in something coming out of the container? Our aim is to ensure that the drug product is well packaged and safe for the patient.
PH: Are you launching new products here?
Haines: There is special emphasis on ready-to-use containers, and we will be completing our portfolio with nested cartridges. This means taking the concept from pre-filled syringes, which come in standardised nests & tubs and are pre-sterilised, and applying it to other packaging categories such as vials and cartridges. As a result the pharmaceutical companies can use their filling lines in a very flexible way and fill even smaller batches efficiently. This concept mainly targets biotech drugs, or pre-clinical-type work.
PH: Glass is still the material of choice for vials but various technical issues go with it. How are you addressing that?
Haines: SCHOTT is a materials development company. We are active in glass development but we also offer cyclic olefin copolymers for prefilled syringes, for example. Our goal is to provide the best packaging solution for the formulation – there’s not one magic container or perfect material for all drug product formulations. That’s one reason why drug development takes so long: you not only have to make the molecule stable and find the right formulation for administration to the patient, you then have to find packaging materials that will not adulterate it and will keep it stable for the intended shelf life. Glass has low extractables and is impermeable to oxygen and moisture, it is transparent, and it has good break resistance. Plastics are not quite as fragile if you drop the container but can be harder to handle on production lines and there are more organic extractables. Depending on what your API is, that can be a challenge.
PH: How is business right now?
Haines: Very good. It’s a growing market section for SCHOTT. Our strategy is global, we have 16 converting and 4 tubing production sites across the world offering regionalised supply of over 10 billion containers per year to pharmaceutical companies and contract fillers. Analytical testing by SCHOTT pharma services is conducted under ISO17025 accreditation at our main laboratory in Mainz, Germany and our newly opened US laboratory in Duryea, PA. We see a growing demand in this field, too.