News from GMP area

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Patient free of HIV after stem-cell therapy, 20th of March 2019.

As direct effect of a continued stem-cell therapy, a British HIV patient with Hodgin lymphoma could not only be successfully medicated against lymph bland cancer, but was also verified to be free of virus for 18 months.

This was reported by Jana Zeh in ntv ( and refers to the Accelerated Article Preview of a nature article, "HIV-1 remission following CCR5Δ32/ Δ32 haematopoietic stem-cell transplantation" published on 5th of March 2019.

This case of the “Londoner Patient” resembles the patient history of the “Berliner Patient” in 2008: an HIV patient suffering from blood cancer who depends on a bone-marrow donation. Here again, besides being cured from leukemia, the patient´s blood did not reveal any HI viruses for more than three years. Therefore, this patient was considered being cured from HIV and went down in medical history. For both patients, donators with both, specially well-matched genetic features and a special mutation in their genes preventing an infection with HI viruses, were found. But still, experts don´t want to speak of having HIV cured yet. Even though repeatability is a decisive criterion, many setbacks of therapy trials are documented. Anyway, there is a common agreement that, also in future, stem-cell transplantation is not the method of choice for therapy of HIV infections as this high-risk therapy is not justified in the face of long-term well-tolerated antiviral therapy. Only for cancer patients with HIV infection, stem-cell transplantation could be an option. However, searching the matching donor is a very intense procedure, as only 1 % of the total population is carrier of the HIV-preventive mutation.


Further information

Dr Claudia Papewalis is giving a GMP for ATMP training


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".