News from Valicare

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Valicare offers consulting on GMP-compliant development of cancer therapies, 13th September 2017.

Extended consulting for biotech companies

  • Valicare customer polybiocept develops new forms of cell therapy
  • International quality requirements call for high standardization
  • Expert support for the reliable transition from laboratory to production scale

Frankfurt/Main, Germany ‒ 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. Since 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.

About Valicare

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.

 

Further information


 
 
Dr Claudia Papewalis is giving a GMP for ATMP training

GMP for ATMPs

If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

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GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

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„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".