Once a beer brewery, now maker of Penicillin V

Kundl, Austria—It’s always a fascinating thought that your unassuming generic pain-killers or anti-infectives are actually produced by some of the most technologically advanced laboratories on earth. When one actually sets foot in one of these multibillion-dollar facilities, it does seem that humanity’s survival lies in that small pill on the palm of your hand, ready to serve its purpose once you wash it down your gut.

Inquirer Health and Science was offered a rare glimpse of the Sandoz headquarters in this tranquil Austrian town. First, however, this writer was briefed in its global headquarters in Holzkirchen, Germany, a small town about 35 km south of Munich, by Sandoz executives Chris Lewis (head, global issues management and biopharma communications), Lisa Richert (head, country communications strategy), and executive assistant Daniela Stolley.

Sandoz, a division of Novartis, is the generics arm of the pharmaceutical giant. Generics, accordingly, are successors to pharmaceutical products whose patent protection has expired. Generic medications are just as effective as the original branded equivalents, but are sold at considerably lower prices.

Sandoz, by virtue of being part of a pharmaceutical company, enjoys the best of both worlds, so to speak, because its generics portfolio is backed up by extensive research and development emanating from Novartis. Sandoz also reinforces the point of the Bioequivalence Study proving that generic medicinal products are identical to the previously patented original. This clinical comparative study guarantees that generic medicines contain the identical active ingredient, dosage, effect and patient tolerance.

Penicillin V capital of the world

After the Munich briefing, this writer was then led to what was called the Penicillin V capital of the world at the Kundl plant in Austria. In 1951, chemists Hans Margreiter and Ernst Brandl developed Penicillin V in Kundl, and hence the drug could be administered orally.

The Kundl plant is Sandoz’s first and largest manufacturing facility. It is located on the western outskirts of the town of Kundl in the Lower Inn River Valley.

This sleepy town has a population of about 4,000. The plant has implemented a number of steps to protect groundwater flow and the Inn River.

For years, Sandoz has used primarily filtered water from the Inn River rather than from groundwater. The Kundl plant treats and purifies five separate wastewater systems, as Dr. Johann Knoflach, head of chemical production pharma of Sandoz’s biotech production, and Julia Ager Gruber, communications head of Sandoz, shared.

They also cited that Sandoz complied with all requirements set forth in the Austrian Water Law Permit concerning readings and procedures. Readings are taken daily and pH is measured continuously, whereby these values are kept within the permitted pH tolerance levels of 6.5 to 8.5.

Heart of production process

The Kundl plant was founded in the small Kundl Beer Brewery in 1946. The plant’s grounds presently cover more than 270,000 sq m, of which 80,000 have construction works and 115,000 have compacted surface, and are accessible via the Inn Valley Freeway, state highway and a company-owned rail spur.

Surprisingly, it is fermentation—the heart and soul of Sandoz’s production processes—which is the common denominator between penicillin and beer, Knoflach explained.

What happens during fermentation is that active ingredients are produced by fungi or bacteria. These are placed in huge steel vats and then cultured under constant stirring, the addition of agricultural raw materials and sterile air. The active substances are then removed from the fermentation matrix, isolated in subsequent processing facilities and, finally, purified. The microorganisms are consistently optimized for greater productivity using classic and molecular-genetic processing methods.

Product groups generated include 1) The antibiotics: Penicillin V, cephalosporin C, pleuromulin; 2) The proteins: Diverse human proteins; 3) Enzymes: Split enzymes as catalysts to replace chemical splitting processes, e.g., in the downstream processing of antibiotics; and, 4) Detergent enzymes for the environmentally benign removal of impurities.

Aside from the Sandoz management, other units located here are the anti-infectives business unit, business units for pharmaceuticals final products, anti-infectives (active ingredients for antibiotics) and biopharmaceuticals. Other active ingredients and other pharmaceutical products are also produced here. This is also where logistics, engineering technology, research and development, product approval, quality assurance as well as a number of administrative functions are conducted.