Valicare GmbH, a wholly owned subsidiary of Bosch Packaging Technology, has expanded its consulting services for Good Manufacturing Practices (GMP) to include biotech companies.
Amongst others,Valicare is currently supporting the Swedish start-up polybiocept in establishing new cancer therapies. In a long-term project, the company ensures that all laboratory processes are standardized in compliance with GMP, the guideline for quality assurance of production processes and their environments. It plays an especially important role in the pharmaceutical industry, as quality defects in drugs can impact patients’ health. Valicare also offers comprehensive qualification and documentation services for pharmaceutical research laboratories.
A high degree of standardization required
The polybiocept group develops new types of cell therapies for the treatment of pancreatic carcinoma and glioblastoma. Pancreatic cancer has the highest mortality rate with approximately 90 percent of all patients dying from the disease within five years and more than 70 percent within the first year following diagnosis. Glioblastoma represents approximately 15 percent of all primary, and the majority of all malignant brain tumors. Patients have an average survival rate of 14.6 months; 95 percent of patients die within five years.
Following successful approval, these cell therapies will be produced and applied at many different specialized centers. “For this reason, we recommended that polybiocept use a decentralized production concept,” explains Dr Hans-Georg Eckert, senior project manager and GMP consultant at Valicare. It is especially important that the method of production complies with international pharmaceutical requirements. “The transfer of the cell-culturing processes developed at the research laboratory to a GMP-compliant manufacturing process requires an especially high degree of standardization. Biotech companies can profit from the long-standing experience of Valicare in GMP consulting for pharmaceutical companies,” says Dr Eckert.
Ensuring rapid market availability for new therapies
In the approach developed by polybiocept, cells from the patient’s own immune system are extracted from the tumor, isolated in a cell culture dish, multiplied and
subsequently used to attack the tumor. “Our collaboration with Valicare is an essential building block to ensure that many patients are given the chance to benefit from these innovative therapies in the future,” says Prof Dr Markus Maeurer, physician and chief scientific officer at polybiocept. Together with Dr Ernest Dodoo, neurosurgeon and chief development officer at polybiocept, he plays a decisive role in the clinical development of new cell therapies.
An active role in the fight against cancer
For many years, the entire Bosch group has played an active part in the fight against cancer. In 2016 the Robert Bosch GmbH initiated the “Alliance Against Cancer” together with the Bosch Foundation and the Robert Bosch Hospital. The laboratory and manufacturing equipment from Bosch Packaging Technology is also suited for the development and production of anti-cancer drugs.
About the polybiocept group
The polybiocept group is dedicated to advancing cell therapies and cell therapy derived technologies, with an initial focus on cancer. The company’s fields of activity range from scientific concepts to registered treatments.
Since 2002, Valicare is a wholly owned subsidiary of Bosch Packaging Technology division, business unit Pharma with more than 50 employees. In addition to the company headquarters in Frankfurt/Main, Germany, Valicare also has facilities in Trencín, Slovakia, a joint venture between Valicare GmbH and Heitec AG. Every year, Valicare completes more than 100 individual projects in the areas of GMP compliance consulting, qualification/validation, as well as quality management for the medical product manufacturing industry.
Dr Hans-Georg Eckert,
phone: +49 69 7909-343
phone: +49 7951 402-648
Based in Waiblingen near Stuttgart, Germany, and employing 6,300 associates, the Bosch Packaging Technology division is one of the leading suppliers of process and packaging technology. At over 30 locations in more than 15 countries worldwide, a highly-qualified workforce develops and produces complete solutions for the pharmaceuticals, food, and confectionery industries. These solutions are complemented by a comprehensive after-sales service portfolio. A global service and sales network provides customers with local points of contact. More information is available online at www.boschpackaging.com
The Bosch Group is a leading global supplier of technology and services. It employs roughly 390,000 associates worldwide (as of December 31, 2016). The company generated sales of 73.1 billion euros in 2016. Its operations are divided into four business sectors: Mobility Solutions, Industrial Technology, Consumer Goods, and Energy and Building Technology. As a leading IoT company, Bosch offers innovative solutions for smart homes, smart cities,connected mobility, and connected manufacturing. It uses its expertise in sensor technology, software, and services, as well as its own IoT cloud, to offer its customers connected, crossdomain solutions from a single source. The Bosch Group’s strategic objective is to deliver innovations for a connected life. Bosch improves quality of life worldwide with products and services that are innovative and spark enthusiasm. In short, Bosch creates technology that is “Invented for life.” The Bosch Group comprises Robert Bosch GmbH and its roughly 440 subsidiaries and regional companies in some 60 countries. Including sales and service partners, Bosch’s global manufacturing and sales network covers nearly every country in the world. The basis for the company’s future growth is its innovative strength. At 120 locations across the globe, Bosch employs some 59,000 associates in research and development.
Additional information is available online at www.bosch.com