Haema AG

Berlin, Germany
Berlin, Germany
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Jones C.,Max Planck Institute for Molecular Biomedicine | Jones C.,Universittsklinikum Munster | Denecke J.,University of Oxford | Strter R.,University of Oxford | And 21 more authors.
American Journal of Pathology | Year: 2011

We describe a novel type of human thrombocytopenia characterized by the appearance of giant platelets and variable neutropenia. Searching for the molecular defect, we found that neutrophils had strongly reduced sialyl-Lewis X and increased Lewis X surface expression, pointing to a deficiency in sialylation. We show that the glycosylation defect is restricted to α2,3-sialylation and can be detected in platelets, neutrophils, and monocytes. Platelets exhibited a distorted structure of the open canalicular system, indicating defective platelet generation. Importantly, patient platelets, but not normal platelets, bound to the asialoglycoprotein receptor (ASGP-R), a liver cell-surface protein that removes desialylated thrombocytes from the circulation in mice. Taken together, this is the first type of human thrombocytopenia in which a specific defect of α2,3-sialylation and an induction of platelet binding to the liver ASGP-R could be detected. © 2011 American Society for Investigative Pathology.

May M.,St Elisabeth Hospital Straubing | Brookman-May S.,St Elisabeth Hospital Straubing | Hoschke B.,Carl Thiem Hospital Cottbus | Gilfrich C.,St Elisabeth Hospital Straubing | And 6 more authors.
Cancer Immunology, Immunotherapy | Year: 2010

About 30% of renal cell carcinomas (RCC) will develop recurrence after surgery. Despite evidence for a significantly improved survival by autologous tumour cell vaccination therapy, the procedure has not become standard. Between August 1993 and December 1996, 1,267 RCC patients undergoing radical nephrectomy in 84 German hospitals were subsequently treated by autologous tumour cell vaccination therapy. The study group comprised 692 patients with complete follow-up (stages pT2-3, pNx-2, MO based on the TNM classification, 4th edition). Subsequent propensity-score matching according to 7 defined criteria with 861 control patients undergoing nephrectomy alone without adjuvant treatment at the Carl-Thiem-Hospital Cottbus, resulted in 495 matched pairs. Overall and stage-specific survival rates were analysed after a median follow-up of 131 months. The 5- and 10-year overall survival (OS) rates were 80.6 and 68.9% in the vaccine group and 79.2 and 62.1% in the control group (p = 0.066). Patients with pT3 stage RCC revealed 5- and 10-year OS rates of 71.3 and 53.6% in the study group and 65.4 and 36.2% in the control group (p = 0.022). In multivariable analysis, patients in the vaccine group showed a significantly improved survival both in the whole study group (HR = 1.28, p = 0.030) and in the subgroup presenting with pT3 stage tumours (HR = 1.67, p = 0.011). Adjuvant treatment with autologous vaccination therapy resulted in a significantly improved overall survival in pT3 stage RCC patients, suggesting benefit especially in this subgroup. However, controlled clinical trials integrating the recent TNM classification and further risk constellations are required to define additional patient groups that may derive benefit from this treatment. © 2009 Springer-Verlag.

Inspections by authorities are performed on a regular basis at pharmaceutical manufacturers to assess the GMP and regulatory compliance. Such inspections are not only performed by the local authority but also by authorities from foreign countries. Especially inspections by the US Food and Drug Administration (FDA) are of utmost importance for the companies concerned. But FDA inspections can be passed successfully provided that they are prepared thoroughly. Besides the different types of inspections and their potential consequences this article describes especially the preparation of inspections. Furthermore, the dos-and-donts during such inspections are explained and all employees should be trained in this. One chapter focuses on inspections by German authorities. The advice given for the preparation as well as for the behaviour during the inspection is not only applicable to FDA inspections but to inspections by any authority and also to customer audits. Several examples from the personal experience of the author as auditor and escort of inspections should help to understand the rules during authority inspections and customer audits. © ECV • Editio Cantor Verlag.

Until recently, the FDA had published two guidelines on equipment qualification and process validation. That was the "Guideline on General Principles of Process Validation", that was published in 1987. Furthermore, it was the Guidance for Industry "Process Validation: General Principles and Practices", published in 2008 as a draft version. This draft has just been finalized on January 24, 2011 and is valid now. This article presents both guidelines and describes the different procedures for qualification/validation. Finally, there is an assessment of both guidelines also with respect to the annex 15 of the EU GMP Guide. © ECV Editio Cantor Verlag.

Diekamp U.,Haema AG | Gneissl J.,E.B.P.S. Logistics G.m.b.H. | Rabe A.,Haema AG | Kiessig S.T.,Ruhr Plasma Zentrum Bochum
Transfusion Medicine and Hemotherapy | Year: 2015

Background: Reports on unexpected events (UEs) during blood donation (BD) inadequately consider the role of technical UEs. Methods: Defined local and systemic UEs were graded by severity; technical UEs were not graded. On January 1, 2008, E.B.P.S.-Logistics (EBPS) installed the UE module for plasma management software (PMS). Donor room physicians entered UEs daily into PMS. Medical directors reviewed entries quarterly. EBPS compiled data on donors, donations, and UEs from January 1, 2008 to June 30, 2011. Results: 6,605 UEs were observed during 166,650 BDs from 57,622 donors for a corrected incidence of 4.30% (0.66% local, 1.59% systemic, 2.04% technical UEs). 2.96% of BDs were accompanied by one UE and 0.45% by >1 UE (2-4). 6.3% of donors donating blood for their first time, 3.5% of those giving blood for their second time, and 1.9% of donors giving their third or more BD experienced UEs. Most common UEs were: discontinued collections due to venous access problems, repeated venipuncture, and small hematomas. Severe circulatory UEs occurred at a rate of 16 per 100,000 BDs. Conclusions: Technical UEs were common during BD. UEs accompanied first and second donations significantly more often than subsequent donations. © 2015 S. Karger GmbH, Freiburg.

Diekamp U.,Haema AG | Gneissl J.,E.B.P.S. Logistics GmbH | Rabe A.,Haema AG | Kiessig S.T.,Haema AG
Transfusion Medicine and Hemotherapy | Year: 2014

Background: Reports on unexpected donor events (UEs) during preparatory plasmapheresis (PPP) are scarce, and rarely consider technical UEs. Methods: Defined local and systemic UEs were graded by severity; technical UEs were not graded. On January 1, 2008, E.B.P.S.-Logistics (EBPS) installed the UE module for plasma management software (PMS). Donor room physicians entered UEs daily into the PMS. Medical directors reviewed entries quarterly. EBPS compiled data on donors, donations and UEs from January 1, 2008 to June 30, 2011. Results: 66,822 UEs were observed during 1,107,846 PPPs for a corrected incidence of 6.55% (1.4% local, 0.55% systemic, 4.6% technical UEs). 3.36% of PPPs were accompanied by 1 UE and 1.18% by >1 UE (2-5). 13.7% of donors undergoing PPP for the first time, 9.7% of those having a second PPP and 4.0% of those having a third or more PPPs were associated with UEs. Most common UEs were repeated venipuncture, and broken-off collection due to venous access problems and small hematomas. Severe systemic UEs occurred at a rate of 36 per 100,000 PPPs. Conclusions: Technical UEs were common with PPP. UEs accompanied first and second donations significantly more frequently than for subsequent donations. © 2014 S. Karger GmbH, Freiburg.

Ziegler V.G.,University of Salzburg | Knaup J.,University of Salzburg | Stahl D.,Paracelsus Medical University | Stahl D.,Haema AG | And 2 more authors.
Lasers in Surgery and Medicine | Year: 2011

Objectives A major obstacle for permanent cancer eradication is the persistence of circulating tumor cells (CTCs) in blood, which often escape radio- or chemotherapy. Currently no efficient strategy to remove CTCs from peripheral blood in order to lower the risk of metastases or tumor recurrence exists. Photodynamic treatment (PDT) using aminolevulinic acid (ALA) induced protoporphyrin IX (PPIX) as photosensitizer offers an innovative approach to overcome this problem. This study aims at providing basic evidence towards fluorescence detection and photodynamic depletion of scattered cancer cells from blood preparations. Methods The breast cancer cell line T47D, endothelial GP8 cells, red blood cells (RBCs) and peripheral blood mononuclear cells (MNCs) have been tested for ALA-induced formation kinetics of PPIX by flow cytometry and microplate fluorescence analysis. The influence of the presence of RBCs on the PPIX-accumulation in cancer cells was evaluated by flow cytometry; the efficacy of PDT on cancer cells and MNCs has been tested by resazurin assay. Mixtures of T47D and GP8 cells and MNCs spiked with cancer cells were tested to determine the limit of fluorescence detection by flow cytometry and antibody co-staining. Results T47D cells accumulated significantly higher PPIX-amounts after ALA-incubation than any other cell type tested. The presence of RBCs had no impact on PPIX-formation in T47D cells. Experiments towards the fluorescence detection of cancer cells in blood revealed that the sensitivity of this method is yet limited. Viability testing after PDT showed that cancer cells where almost completely eradicated after illumination whereas MNCs were almost spared. Conclusion We clearly demonstrate in vitro tumor cell selectivity of PPIX-accumulation over endothelial cells, MNCs and RBCs. Breast cancer cells are efficiently killed by PDT with minor depletion of MNCs. Our findings provide a basis for the PDT of blood samples for a future depletion of CTCs. Copyright © 2011 Wiley-Liss, Inc.

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