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 standardised 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 standardisation 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% within the first year following diagnosis. Glioblastoma represents approximately 15% of all primary, and the majority of all malignant brain tumours. 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 specialised centres. “For this reason, we recommended that polybiocept use a decentralised 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 standardisation. 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 tumour, 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.