TAPI's Unique Combination of Technology, Science and Talent Brings Levodopa API Production to Global Markets
By Péter Kerekes, TAPI Site Production Head, Sajóbábony, Hungary
Bringing together unique technology with scientific expertise, TAPI is now fulfilling customer demand for high quality Levodopa API from our own state-of-the-art production facility in Sajóbábony, Hungary.
Planning began several years ago and today this dedicated production line is fully operational. With this new facility, world class technology, and talent, we are able to meet the needs of more customers and our system ensures we’ll be able to supply high quality Levodopa API.
*Taken from TAPI's product catalog - The drug is primarily indicated for treatment of Parkinson-like disorders and is usually given in conjunction with other medications that block its conversion to dopamine before it enters the central nervous system CNS. To Download the latest version of our catalog - click here
TAPI develops advanced technology to increase Levodopa supply
Earlier generations of Levodopa production began with a crude API extracted from beans then recrystallized, forming the API. This method of production relied heavily on the weather and climate to produce Levodopa in sufficient quantity to meet our high standards of quality and compliance. TAPI set out to develop a new process that no longer depended on climate or weather conditions and would enable us to consistently produce high-quality material at high capacity.
In 2010, TAPI developed a proprietary enzymatic technology that allows us to grow the cells containing the enzyme used to produce the Levodopa API. TAPI’s R&D team in Hungary developed its own strain, which has high enzyme-producing capacity. After further refining the strain and conducting extensive lab testing, we launched two pilots to develop an effective separation process, which is an essential step in production. At a small, low-capacity plant on the Sajóbábony site, we installed two separators and tested a combination centrifuge dryer system to create the right conditions to isolate the product. It was important to test this technology with the regular reactors to ensure we could scale up production. The second phase of the pilot tested carbon cartridge filtration, to efficiently filtrate the Levodopa solution and remove some of the impurities and the coloring agent.
Building on the success of the two pilots, in 2013 we were ready to enter an exciting new phase: designing and building a high-capacity Levodopa production system in a new plant in Sajóbábony. The system came online last year and its highly sophisticated technology, coupled with advanced automation, enables us to produce Levodopa API which meets stringent industry requirements and manufacturers’ demand.
State-of-the art production yields quality results
The new Sajóbábony facility is highly automated, operating a dedicated Levodopa production line with maximum efficiency that is managed by a small team of highly-trained operators. Through careful strain selection and strain improvement, TAPI has streamlined the process for high productivity and yield. The plant's fermenters are equipped with an efficient separator system that separates the cells from the other components in the fermentation mixture, then washes them. From there the substrate undergoes bioconversion in converters where the Levodopa molecule is created from substrates. In-process control (IPC) continuously monitors the substrate during production to ensure the concentration meets quality requirements using near infrared (NIR) technology. After bioconversion, a combination centrifuge-dryer unit is used for isolation. TAPI chose the combined system because it is better suited for high capacity API production. Finally, to minimize impact on the environment, the plant uses a sterilizer and a dedicated absorber system.
After the material is produced, it is transferred to TAPI’s plant in Debrecen, Hungary. There, micronizing and grinding take place, creating the product form that meets customer specifications. The Debrecen warehouse stores the final product and serves as the marketing point for customer orders.
TAPI’s unwavering commitment to quality means we maintain high standards at all times, and that ensures we are well-prepared for inspections by health and regulatory authorities. In 2014 the FDA inspected the Levodopa pilot plant, then returned in March of this year to inspect the Debrecen site. In both cases, investigators noted no deviations.
A skilled workforce manages complex customer needs
Just as important as having advanced scientific processes and technology is having an experienced team that knows how best to use it. TAPI’s R&D scientists and quality and production experts work closely to ensure our processes continuously operate at peak efficiency and at the highest level of quality. With more than a decade of experience in fermentation, many of our operators are experts in this field. Our team brings deep scientific and operational knowledge from their work at TAPI, as well as other industry experience, which makes them uniquely qualified to manage complex projects at the Sajóbábony and Debrecen sites.
As part of TAPI’s culture of continuous improvement, we are working on enhancements to fine tune Levodopa API production so capacity keeps pace with market demand over the long-term. We look forward to continuing to partner with our customers, and deliver a high quality Levodopa API that meets their manufacturing and market needs for years to come.
Péter Kerekes is the site production head for TAPI’s plant in Sajóbábony, Hungary and has extensive research and production experience. Prior to joining TAPI nearly 10 years ago, he earned an MSc degree, with a concentration in pharmaceutical chemistry.
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