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Valicare offers GMP for ATMPs training

If you like to find out more about the development of novel therapies, you have the opportunity to attend a training course at our company side at Frankfurt/ Main.

Developing new cancer therapies

Dr Ernest Dodoo, neurosurgeon and chief development officer at polybiocept, is catching up on the exact condition before the surgery of a tumor. Valicare supports the Swedish company in establishing new cancer treatments.

GMP-compliant manufacturing process

Valicare supports the start-up polybiocept in transferring the cell-culturing processes developed at the laboratory into a GMP-compliant manufacturing process. Prof Maeurer, physician and chief scientific officer at polybiocept, is looking at visualized cell cultures on the screen.

Content

New action plan to foster development of advanced therapies, 30th of October 2017

The European Commission's Directorate-General for Health and Food Safety (DG Sante) and the European Medicines Agency (EMA) in collaboration with the Member States competent authorities published a joint action plan to foster the development and authorization of advanced therapy medicinal products (ATMPs). The main aim is to streamline procedures and better address the specific requirements of ATMP developers. The plan published contains 19 actions in different areas, some already in place and others new.

Examples of upcoming actions include:

  • European Commission guideline on good manufacturing practice for ATMPs, to reduce the administrative burden and adapt the manufacturing requirements to the specific characteristics of ATMPs
  • new EMA scientific guidelines on ATMPs, including investigational ATMPs, to clarify regulatory expectations

For more information about the new action plan for ATMPs look at the publication of the EMA.

New guideline (EU) 2017/1572 postulates urgent need of a GMP-ATMP guideline, 15th of September 2017

A new Directive 2017/1572 was published on September 15th 2017 by the European Commission which paves the way for handling Advanced Therapy Medicinal Products (ATMPs) independently of other medicinal products for human use.

What is the background?

ATMPs are Advanced Therapy Medicinal Products and, as defined by Directive 2001/83/EC, investigational medicines for human use based on gene therapy, somatic cell therapy, tissue engineering, or combinations of these products which offer groundbreaking new opportunities for the treatment of disease and injury.

The directive 2003/94/EU explicitly defined for the first time that "investigational medicinal products intended for use in human" have to be regulated together with all other medicinal products with regard to Good Manufacturing Practice (GMP), a pharmaceutical quality management system and Good Clinical Practice (GCP) based on Directive 2001/83/EU. Subsequent Regulation (EC) 1394/2007 brought greater precision and legal binding. Thereby, ATMP requirements have been defined along with finished medicinal products although it can barely reflect the specific features of ATMPs.

ATMPs are often used in individualized approaches so that requirement for other medicinal products interfere its development due to the heterogeneity of the starting material, small batches and low shelf life. Complex and fixed requirements and the obligation to use constant manufacturing processes are therefore a hindrance for further development and launching these innovative products.

The 1394/2007 Regulation already stated that "the novelty, complexity and technical specificity of advanced therapy medicinal products require specially tailored and harmonized rules” which should be adopted and recommended to establish guidelines for ATMP under GMP (EC 1394/2007 Article 5). The new Directive 2017/1572/EU now refers to Article 5 of this Regulation, calls for a thorough examination and a delegated act establishing GMP principles for ATMPs by repealing the Directive 2003/94/EC (2017/1572 Article 15).

Now the way should be clear to complete the long-term examination and to give developers and manufacturers of ATMP more legal certainty through a separate GMP-ATMP guideline! We are looking forward to it!

 

Press Release, 13th of September 2017

Bosch subsidiary Valicare offers consulting in GMP-compliant development of cancer therapies

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.

Press photo: #1161814; # 1161815

Contact:

Dr. Hans-Georg Eckert

phone: +49 69 7909-343

Contact person for press inquiries:

Nicole König

phone: +49 7951 402-648

Cell-based gene therapy for the treatment of acute lymphatic leukemia (ALL) receives FDA approval

In the United States, the U. S. Food and Drug Administration (FDA) has approved a gene therapy for the first time at 30th of August. Henceforth, the treatment of ALL in young patients up to 25 years is allowed, who couldn’t be cured with actual methods so far.

Even the FDA describes this as a historic step towards treating cancer and other life-threatening diseases with completely new approaches.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb, M.D.

Kymriah is based on the chimeric antigen receptor therapy known as CAR-T cell therapy. Patient's own T cells are genetically modified in vitro using viral vectors in such a way, that they detect specific antigens (CD19) on the surface of the tumor cells, when given back to the patient.

This method of genetically modified autologous T-cell immunotherapy does not only attack the tumor directly, but activates the patient's own immune system to take targeted action against the cancer.

The safety and efficiency of the Kymriah method has been tested in a study with 63 ALL patients (children and young adults). The remission rate was 83% within the first three months. Despite severe side effects, which can arise and a lack of long-term prognoses, treatment with Kymriah is a great opportunity for young patients with ALL who hasn’t had hope any longer.

 

Response to ATMP GMP Guideline, 1th of September

If you like to know what others think about the ATMP GMP guideline proposed by the European Commission (EC) and the European Medicines Agency (EMA), please read the summary of the EC:

"SUMMARY OF THE REPSONSES TO THE TARGETED STAKEHOLDER CONSULTATION ON THE DEVELOPMENT OF GOOD MANUFACTURING PRACTICE FOR ADVANCED THERAPY MEDICINAL".

All 53 comments received during the stakeholder consultation process from June to September 2016 were recorded, analyzed and summarized.

Most of the commentators welcomed the guideline. Requests remained on the relation between the actual draft guidelines on GMP specific to Advanced Therapy Medicinal Products to the GMP guidelines. They have to beclarified due to the specific characteristics of ATMPs. Therefore, some additional adaptations are required in terms of manufacturing conditions, validation of the aseptic manufacturing process, and ongoing stability testing. Just as important is a greater flexibility regarding the tasks of the qualified person.

Read the summary of the EC or have a look at the list of all comments submitted to the EC in detail.

GMP Training Course at Biopark Regensburg, 19th of July

Dr. Hans-Georg Eckert, GMP Senior Consultant at Valicare GmbH, executed a GMP Training Course at the lecture hall of Biopark in cooperation with the Biopark Regensburg. The numerous participants coming from university and university hospital demonstrates that GMP is a subject in the academic fields too. Beyond that representatives of biotech companies of the Biopark or BioRegio Regensburg followed the invitation to fresh up their GMP knowledge and to get answers on special questions. All participants finished the training successfully and took a GMP training certificate home. An ongoing cooperation with the Biopark Regensburg is scheduled.

 

GMP-Compliance audit, 5-6th of July 2017

The ATMP GMP Audit Team of the Valicare GmbH executed a GMP compliance audit from 5-6th of July at a potential contractual partner of an internationally working pharmaceutical company. The manufacturing of an Advanced Therapy Medicinal Product (ATMP) was proved on GMP compliance to formulate the frame conditions for the quality agreement and the requirements for the product. Initial application of the ATMP is planned under hospital exemption regarding §4b of the German Drug Law and shall be followed by a central European marketing authorization in the near future.

Forum Science & Health, Fürstenfeldbruck, 5th to 6th of July 2017

Forum Science & Health, an event of the “Cluster Biotechnology Bavaria”, takes place at Fürstenfeldbruck near Munich. Personalized medicine of the future is the focus of the meeting. An interdisciplinary viewing and discussions with the aim of developing a medicine bypassing all the different medical fields.

Meet Valicare GmbH at our booth at “Altes Foyer” and find out which GMP services we can provide you in this specific field of technology.

 

APV Focus Group Meeting at Robert Bosch GmbH, 19./20.06.2017

APV Focus Group PharmaBiotechnology will come together at the Robert Bosch Packaging Technology GmbH side in Crailsheim, following an invitation of Dr. Hans-Georg Eckert, Senior Project Manager & GMP Consultant at Valicare GmbH, Frankfurt.

The APV Focus Group representing the area of pharmaceutical biotechnology is engaged with the production and application of drugs or medical devices under application of whole organisms or parts of them. On the regular occurring meetings scientific and methodical information are exchanged. This time lectures like “Newest status of GMP for ATMP“ und “Manufacturing of investigational drug products and starting material for cell and gene therapy” are planned before a sightseeing at the Bosch Packaging Technology side in Crailsheim, competence center for construction and manufacturing of aseptic filling lines, will start.

“Annual Report 2016” of EMA indicates a positive trend for ATMP, 19.06.2017

In the actual “Annual Report 2016” the EMA published, that the number of adopted recommendations for Advanced-therapy medicinal products (ATMP) increased continuously over the last 4 years and reached a peak in 2016.

ATMP are defined as “advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering.” They have a big potential for treatment of diseases where conventional approaches are inadequate. ATMP developers have the opportunity to apply their draft opinion on ATMP application. Before the appropriate authority CHMP (Committee for Medicinal products for Human Use) adopts a final decision, the brains trust of CAT (Committee for Advanced Therapies) is responsible to review the certification of quality and non-clinical data and provides scientific recommendations on the classification of ATMPs for assessing the quality, safety and efficacy of ATMPs.

In 2016, the number of ATMP argued for recommendation increased from 31 to 87 in comparison to 2015. Thereby, the small and medium-sized enterprises (SME) represented a significant higher proportion than academia. All this leads to a situation that ATMP will have higher impact in medical treatment in the future.

 

Valicare establish “audit and inspections” as a new business segment, 21.03.2017

Under the management of Mr. Mohsen Masoumi, Senior Consultant, Valicare’s audit services support are extended. If you need support for GAP-Analysis, Mock-inspections, “3rd Party Audits” or other audit services, contact us, please.