To download the press release, please click here.

Berlin, December 17, 2015
Aptahem AB is a biotechnology company based in Sweden which develops a group of patented RNA aptamers. Aptahem´s lead compound APTA-1 is currently being characterized in their preclinical programs.

Accelero Bioanalytics is pleased of being selected as a preferred cooperation partner for Aptahem´s APTA-1 preclinical drug development towards the clinical stage. Based on its strong expertise in this field, Accelero provides bioanalytical assay development and validation capabilities. One of this sensitive methods is specific for APTA-1 in biological matrices like plasma or tissues, and will be progressively advanced according to regulatory guidelines.

About Accelero Bioanalytics

The company is a privately held contract research organization (CRO) with headquarters in Berlin, Germany. Since October 2015, Accelero´s test facility operates in compliance with the OECD principles of Good Laboratory Practice (GLP). Main focus is the marketing of bioanalytical services for research-based pharmaceutical and biotechnology companies. Accelero´s team develops and validates custom-made bioanalytical testing methods as requested for the characterization of novel drugs or therapies prior to an authorization procedure.

About Aptahem AB

Aptahem develops drug candidates for treating and preventing diseases caused by blockage of blood vessels, such as deep vein thrombosis, stroke or heart failure. Thrombosis and related diseases causes more than 30 percent of all deaths worldwide and can occur from either genetic inheritance, surgery, trauma, medication or other diseases like cancer. The company has granted patents for Europe, USA, China, Canada and a patent pending in India.

Your Contact to Aptahem AB

Mikael Lindstam, CEO
Email: ml[at]aptahem.com
Internet: www.aptahem.com

Your Contact to Accelero Bioanalytics

Christian Lange, Managing Partner
Telephone: +49 30 610 910 300 (Office) +49 30 610 910 307 (GLP Laboratories)
Email: service[at]accelero-bioanalytics.com

For the german version, please click here.

To download the press release (separate versions in german and english are available),
please click here.

 

Accelero Bioanalytics Approved as GLP Test Facility by Competent Authority

Berlin, October 12, 2015
Accelero Bioanalytics announced today that the Berlin State Office for Occupational Safety, Health and Technical Safety as the competent authority has performed an intensive GLP inspection in the company´s bioanalytical testing laboratories at the Berlin Adlershof location on 30 September 2015 and 01 October 2015. The facilities and archives as well as bioanalytical studies have been inspected.

As a result of the GLP inspection the authority recognized that the test facility Accelero Bioanalytics works in accordance with the principles of Good Laboratory Practice (GLP).

The GLP certificate according to Section 19 German Chemicals Act will include the testing categories 1 and 8. Testing category 1 comprises tests for the determination of physicochemical properties and content determination of drugs or drug-excipient mixtures. "In a so-called Impurity Test according the ICH Q3 A guideline bioengineered drugs are being tested for residues of the host organism", explains Christian Lange, the founder and test facility manager.

The testing category 8 includes analytical and clinical chemistry testing on biological material, for example, the detection of drugs in tissues, blood or urine, to allow a characterization of the active ingredient in accordance with regulatory requirements.

With the establishment of a GLP quality assurance, the Accelero team was supported by the expertise of Dr Knoell Consult GmbH in Mannheim. Mr Lange goes on: "We are very pleased that with Mr. Joachim Hajok we could inspire an GLP expert with decades of experience for our small but nice team". Mr. Hajok formerly was the head of the GLP quality assurance unit at the BASF experimental toxicology and ecology site in Ludwigshafen, Germany.

"Four years after the company was founded our motivated Accelero team has reached a new level of quality, which has not been seen before in this form. In retrospect it was not easy to assign positions of the classical GLP organization chart to the Accelero collective members, "Mr. Lange notes with a grin. "But we already register an increased attention in terms of our expertise and our services. Together with our clients we look forward to innovative and exciting projects ".

About Accelero Bioanalytics
The company is a privately held contract research organization (CRO) with headquarters in Berlin. Main focus is the marketing of bioanalytical services for research-based pharmaceutical and biotechnology companies. The service team develops and validates custom-made bioanalytical testing methods as requested for the characterization of novel drugs or therapies prior to an authorization procedure.

After its foundation in 2011, followed by an intermediate phase of establishment, the company opened new laboratory facilities in February 2015 in Berlin Adlershof. The laboratories are approved for projects of the genetic engineering safety level S2. For processing human pathogen projects the company was granted a permission according to Section 49 German Infection Protection Act. Since 01 October 2015, all projects can also be covered by a quality assurance program which fully complies with the principles of Good Laboratory Practice (GLP).

 

Accelero Bioanalytics GmbH als GLP Prüfeinrichtung für Bioanalytik anerkannt

Berlin, den 06. Oktober 2015
Die Accelero Bioanalytics GmbH gibt heute bekannt, dass das Berliner Landesamt für Arbeitsschutz, Gesundheitsschutz und technische Sicherheit (LAGetSi) als zuständige GLP Überwachungsbehörde in den bioanalytischen Prüflaboren des Unternehmens am Technologie-Standort Berlin Adlershof eine intensive GLP Inspektion am 30.09.2015 und 01.10.2015 durchgeführt hat. Es wurden sowohl die Einrichtungen und Archive, als auch bioanalytische Prüfungen inspiziert.

Als Ergebnis der GLP Inspektion wurde anerkannt, dass die Prüfeinrichtung Accelero Bioanalytics GmbH in Übereinstimmung mit den Grundsätzen der Guten Laborpraxis (GLP) arbeitet.

Die GLP Bescheinigung nach §19 Chemikaliengesetz wird die Prüfkategorien 1 und 8 beinhalten. Zur Kategorie 1 gehören Prüfungen zur Bestimmung von physikalisch-chemischen Eigenschaften und Gehaltsbestimmungen von Arzneimitteln oder Wirkstoff-Trägerstoff-Gemischen. „In einem sogenannten Impurity-Test nach der ICH Q3 A Richtlinie wird bei biotechnologisch hergestellten Arzneimitteln auf Rückstände des Wirtsorganismus getestet", erläutert Christian Lange, der Gründer und Leiter der Prüfeinrichtung.
Die Prüfkategorie 8 umfasst analytische Prüfungen an biologischen Materialien, beispielsweise der Nachweis von Wirkstoffen in Geweben, Blut oder Urin, um gemäß den regulatorischen Anforderungen eine Charakterisierung des Wirkstoffes zu ermöglichen.

Bei der Etablierung einer GLP Qualitätssicherung wurde das Accelero Team durch die Expertise der Dr Knoell Consult GmbH aus Mannheim unterstützt. Herr Lange führt weiter aus: „Wir sind sehr glücklich, dass wir mit Herrn Joachim Hajok einen Experten mit jahrzehntelanger Erfahrung im GLP Bereich für unser kleines aber feines Team begeistern konnten." Herr Hajok war langjähriger Leiter der GLP Qualitätssicherungseinheit der experimentellen Toxikologie und Ökologie der BASF SE am Standort Ludwigshafen.

„Vier Jahre nach der Unternehmensgründung ist unser motiviertes Accelero Team auf einem neuen Qualitätslevel angelangt, welches es in dieser Form so noch nicht gegeben hat. Es war rückblickend nicht einfach, aus dem Accelero Kollektiv ohne Hierarchien heraus die Positionen des klassischen GLP Organigramms zu besetzen", stellt Herr Lange schmunzelnd fest. „Aber bereits jetzt registrieren wir eine erhöhte Aufmerksamkeit im Hinblick auf unser Spezialwissen und unsere Dienstleistungen. Gemeinsam mit unseren Auftraggebern freuen wir uns auf innovative und spannende Projekte".

Über die Accelero Bioanalytics GmbH
Das Unternehmen ist ein privat finanziertes Auftragsforschungsunternehmen mit Sitz in Berlin. Schwerpunkt ist die Vermarktung von bioanalytischen Dienstleistungen für forschende Biotechnologie- und Pharmaunternehmen. Das Serviceteam entwickelt und validiert im Kundenauftrag bioanalytische Prüfverfahren, wie sie im Rahmen einer Charakterisierung neuartiger Wirkstoffe oder Therapien im Vorfeld eines Zulassungsverfahrens zur Anwendung kommen.

Nach der Gründung in 2011 und einer sich anschließenden Etablierungsphase wurden im Februar 2015 am Standort Berlin Adlershof neue Laboreinrichtungen bezogen. Die Prüflabore sind für gentechnische Arbeiten der Schutzstufe S2 zugelassen. Für die Bearbeitung von Projekten mit humanpathogenen Erregern liegt eine Erlaubnis nach §49 Infektionsschutzgesetz vor. Seit dem 01. Oktober 2015 können diese Arbeiten zusätzlich durch ein Qualitätssicherungsprogramm abgedeckt werden, dass den Grundsätzen der Guten Laborpraxis (GLP) entspricht.
Die Accelero Bioanalytics GmbH ist Mitglied im Bundesverband Deutsche Startups eV und im Branchenverband BIO Deutschland eV.

Ihr Kontakt zur Accelero Bioanalytics GmbH:
Herr Christian Lange
Telefon: +49 30 610 910 300 (Office) +49 30 610 910 307 (GLP Prüflabore)
E-Mail: service[at]accelero-bioanalytics.com

The Accelero Team is now pleased to announce the official approval for it´s test facility branch to handle and analyze human infectious pathogens. The written permission to grow and handle microbes like Staphylococcus aureus has been received on 11-MAY-2015, and allows Accelero´s lab team to work on projects in compliance with the German Law on the Prevention and Control of Infectious Diseases (IfSG, Infektionsschutzgesetz).

The permission was granted by the Gesundheitsamt Treptow-Köpenick according to § 49 IfSG, and is valid for safety level S2 projects.

The Accelero Team is now proud to provide a 128-bit encryption of all electronic correspondence like emails, and its attachments.

The open source PGP (pretty good privacy) data encryption algorithm is selected to protect all electronical data exchanged with our clients in the course of confidential projects. File attachments like study plans, study reports, intermediate bioanalysis results, etc can also be encrypted, and therefore are only open to recipients who have the personal key of the sender.

If you are interested to learn more on how we respect our customer´s confidentiality needs, please do not hesitate to contact us at any time.

Private investor meets entrepeneur - see the video at Zencap´s blog (in german), or directly on Youtube (in german).

 

In 2015 Accelero Bioanalytics team members will attend to events which will complete our expert knowledge. Get in touch with us to arrange a handshake appointment.

 

6th Berlin LC/MS/MS Symposium

AB Sciex Deutschland GmbH
14 April 2015, Estrel Convention Center, Berlin, Germany
Attendee: Dr Stefanie Heinrich, Study Director Microbiology - Prüfleiterin Mikrobiologie
Link to the event: sciex.com/events/6berliner

 

Opening of Max Planck Research Network for Synthetic Biology "MaxSynBio"

Max-Planck Society - Max-Planck-Gesellschaft
16 April 2015, Harnack-Haus, Berlin, Germany
Attendee: Saskia Schellmann, Study Director - Prüfleiterin
Link to german website: mpg.de/7424658/MaxSynBio
Download flyer: German Program of the Ceremonial

 

Competence Center Germany - Kompetenzzentrum Deutschland 2015

The Economic Council of the Christian Democratic Union - Wirtschaftsrat der CDU
22 April 2015, Berlin Congress Center, Berlin, Germany
Attendee: Christian Lange
Founder & Managing Partner - Gründer & Geschäftsführender Gesellschafter
Link to german website: wirtschaftsrat.de/wirtschaftsrat.nsf/id/kompetenzzentrum-deutschland-2015
Download flyer: German Program Agenda

 

20th Annual DGGF Meeting

German Society for Good Research Practice - Deutsche Gesellschaft für Gute Forschungspraxis (DGGF)
24-25 September 2015, Maritim Hotel, Ulm, Germany
Attendee: Christian Lange (DGGF member), Test Facility Management - Leitung der Prüfeinrichtung
Link to society: dggf.de/en/home/
Download flyer: English Program Flyer

 

EBF 8th Open Meeting - Into New Territories - Explore, Learn and Apply

European Bioanalysis Forum
18-20 November 2015, Hesperia Tower Conference Center, Barcelona, Spain
Attendee: still to be defined ...
Link to society: www.europeanbioanalysisforum.eu
Download flyer: avaliable soon ...

 

Accelero Bioanalytics GmbH, a small biotechnology platform focussing on custom-made ligand binding assay development and validation, is now proud to initiate the certification process according to the German Chemikaliengesetz (ChemG). Main topic is to receive an official GLP certificate granted by the German authority.

Accelero´s innovative business model fills the gap between young Biotech´s need for ligand binding assay development capabilities, and the experience to bring these assays in line with regulatory requirements for IND filing. Our small team does not only provide extensive hands-on expert knowledge, but also a strong background in the field of preclinical drug development in compliance with Good Laboratory Practice (GLP).

The main GLP inspection is expected to be completed by end of June 2015. Accelero Bioanalytics will then maintain a Quality Assurance Unit which fully comply to the OECD guideline No.1.

For Accelero´s customers, this construct will create the pleasant situation to receive PCR and ELISA based services from the assay design to the final pharmacokinetic reporting to EU authorities, all provided from one hand. Accelero is on the best way to become the bioanalytical and quality assurance consultant of choice.

Accelero Bioanalytics team is exclusively formed by academic staff with a strong background in biotechnology, toxicology, and molecular biology. Our team will maintain a genetic engineering safety level S2 area joined to GLP in summer 2015, an ideal combination for ATMP drug development or biopharmaceutical manufacturing in-process quality control.