Parsolex and Bosch Packaging Technology have formed a strategic partnership, granting Parsolex access to the latest Bosch pharmaceutical technologies and Germany-based Bosch access to a manufacturing site in the US to showcase its technological capabilities.
Parsolex is a US-based CDMO focused on providing solutions to clients that involve the production of non-sterile pharmaceutical products, such as supporting innovation, solving formulation problems, tackling manufacturing challenges, improving operational efficiency, and addressing production capacity requirements.
"Parsolex is excited to partner with Bosch Packaging Technology to offer our clients access to the latest solid dosage technology innovations in granulation, coating, tablet compression and capsule weight sorting," said Alfonso Chang, CEO of Parsolex. "Access to Bosch and its technology enhances our capability to work on even more complicated and diverse issues that are challenging our clients' business today."
Parsolex has added Bosch's state-of-the-art granulation, fluid bed coating and drying, tablet compression, tablet drum coating and capsule weight checking technologies to its recently expanded cGMP commercial manufacturing facility in West Lafayette, Indiana, US. Parsolex will now have greater diversity of solid dosage manufacturing technologies with these precision machines.
Parsolex selected the new Bosch equipment to complement its existing capabilities, and the company expects the expanded infrastructure to work well in a range of clinical supply manufacturing programs.
Parsolex believes that adding these new capabilities is a critical element in its strategy to facilitate cGMP production for Clinical Trial Materials and commercial drug products
With this investment, Parsolex continues its commitment to scientific and operational excellence, helping it solve more complicated formulation and drug product manufacturing challenges that its clients face.
Thomas Mauritzen, President of the Bosch Packaging Technology Pharma Division in North America said: "Bosch's strategic partnership with Parsolex offers a showcase of our state-of-the-art oral solid dose manufacturing equipment, which combined with their wealth of expertise, will immediately position Parsolex as a top contract manufacturer for the pharmaceutical industry. With the range of Confidential & Proprietary Information equipment and processes they have in-house, Parsolex can offer their clients the highest level of service and support from development into production."
Parsolex believes that adding these exciting new capabilities is a critical element in its strategy to facilitate cGMP production for Clinical Trial Materials (CTM) and commercial drug products for its clients, as well as a means to inform scale-up conducted during technology transfer to larger-scale production equipment.
The new Bosch capabilities installed at Parsolex's West Lafayette site includes:
- New granulation and precision coating capabilities with Bosch's Pilotmix and Pilotlab platforms that provide high-shear granulation capabilities and spray granulation, coating of fine particles, pellets and microtablets, and drying, respectively. Additionally, this cGMP granulation suite is equipped with pneumatic material transfer capabilities for closed transfers of product to increase production efficiency and state-of-the-art comminuting platforms to offer solutions for achieving the desired particle size distributions by milling and sieving of dry and wet powders.
- The highly efficient Bosch TPR 200 tablet press, which more than doubles Parsolex's tablet compression production rate and allows for greater flexibility, improved yields, and faster changeover times.
- The Bosch Solidlab 2 drum coater, which provides easy scale-up of production parameters for cosmetic and functional film coating of compressed tablet cores, including controlled release applications.
- The Bosch KKE 1700 capsule checkweigher that gives precise gravimetric weighing for 100% capsule weighing and high production uptimes to further enhance Parsolex's current capsule filling capacity, which has produced well over 2.5 million commercial capsule doses.
Parsolex will leverage Bosch's modular data acquisition systems for these new unit operations, which will inform the design and development of robust process parameters and further enhance Parsolex's statistical process control. Parsolex also views Bosch's experience and emphasis on GAMP 5 guidelines during software design as an essential component of the company's ability to comply with 21 CFR Part 11 requirements.
As part of this strategic partnership, Parsolex and Bosch will evaluate research to conduct and publish to demonstrate Parsolex capabilities with Bosch technologies and will evaluate hosting joint events to discuss capabilities, technologies, and other topics pertinent to the pharmaceutical industry.
