News & all the latest

Erneuerung und Erweiterung des GMP-Zertifikates unserer Herstellungserlaubnis

Dear customers,

we are pleased to inform you that, following our successful inspection in July, we have now officially received our GMP certificate and manufacturing authorisation. These successes would not have been possible without the outstanding commitment and excellent performance of our employees, for which we would like to express our sincere thanks.

AZ Biopharm becomes FDA-inspected laboratory

The Analytische Zentrum Biopharm Berlin is pleased to announce that we passed the FDA inspection in September this year without any findings. This success reflects our unwavering commitment to the highest quality standards and our continuous work to ensure the integrity of your products and our services. We thank our customers for their continued trust and endeavour to further strengthen our partnerships. For detailed information about the audit, please do not hesitate to contact us.

AZ Biopharm will attend Bionnale 2023 conference

AZ Biopharm will attend Bionnale 2023 conference – a networking event for start-ups, pharma companies, entrepreneurs and CROs.

Renewed GLP certification

We are pleased to announce that AZB has successfully renewed its GLP certification. This achievement confirms our commitment to high quality and safety in conducting analyses in this field, and provides our customers with the assurance that they are working with a trustworthy and reliable partner.

AZ Biopharm has expanded its analytical toolbox by a recent acquired GC-MSMS from Shimadzu type TQ8060 NX.

With this we can now conduct much more sensitive and selective trace analysis of drug products, APIs, raw materials and phyto-pharmaceuticals. In particular, for the analysis of contaminants as pesticides in cannabis, CBD and dronabinol, GC-MSMS provides the needed sensitivity and selectivity to fulfil the requirements according PhEur.

AZ Biopharm published a guest article in the FAZ on the future of the cannabis business in Germany after the release by the German government

“The coalition agreement of the SPD, Green party and FDP provides for the controlled supply of cannabis to adults for recreational purposes and a permit for cultivation for commercial purposes. With this newly created availability comes the need to systematically analyze and regulate cannabis products to protect consumers from pesticides, biological contaminants and heavy metals. As a certified laboratory, the Berlin-based testing laboratory AZ Biopharm will play a central role in the testing of large batches of cannabis in the future. In this article, the managing directors Dr. Martin Reinsch and Dr. Berthold Lausecker give an overview of the current situation of legalization, the need for exact analysis and possibilities for testing cannabis products.”

Ultra-sensitive Nitroglycerin LC-MSMS assay established for support of BE studies

Nitroglycerin, a vasodilator, is used to treat people who have coronary artery disease. It works by relaxing the blood vessels by releasing nitric oxide so the heart does not need to work as hard and therefore does not need as much oxygen. Nitroglycerin is metabolized to 1,2- and 1,3- dinitro-glycerin, which have still pharmacologic activity. The metabolites have the same mass and the same fragment, and so must be chromatographically separated.

Our contribution to fight Covid-19

As we all learned from the daily communication in the TV and newsletters “boostern” is the best way to prevent infection with SARS-Cov-2.

AZ-Biopharm is present at the International Cannabis Business Conference (ICBC) B2B.

This conference will take place on August 26-27, 2021 at the Vienna House Andel’s Berlin,
Landsberger Allee 106, 10369 Berlin (https://internationalcbc.com/berlin/).

Nitroso-amine screening method established at AZ-Biopharm for 12 N-nitrosamines.

At AZ-Biopharm we established, after the development and validation of a GC-MS and an even more sensitive UHPLC-MSMS method for the determination of N-nitroso-dimethylamine (NDMA) in drugs and in APIs, a screening method for 12 nitrosamines.

AZ Biopharm has started vaccination of personnel against Covid-19

AZ-Biopharm has early on implemented measures to protect our personnel from Covid-19 infections.

AZ-Biopharm invests further in lab infrastructure.

AZ-Biopharm invested more than 50k€ and acquired an emergency power supply to secure the safe storage of our customers samples.

AZ Biopharm increases the rate of strokes

After purchasing and installing 3 new release systems last year, AZ Biopharm recently installed 6 more in-vitro release systems.

Nitrosamines in metformin medicines

Dear Mms and Sirs,

You are sure to be informed about it: Nitrosamines in medicinal products – after valsartan, ranitidine now metformin! Press release from BfArM as of 10/16/2020: The EU supervisory authorities request nitrosamine tests on medicinal products containing metformin. “The European Medicines Agency EMA and the competent national authorities in the EU will contact all marketing authorization holders of metformin-containing medicinal products and ask them to test all metformin-containing finished medicinal products for the presence of nitrosamines before they are released on the market.

AZ-Biopharm will participate and present at the 13th EBF Open Symposium in Cyberspace

AZ-Biopharm will participate on the N° 13 EBF Open Symposium – “From Cyberspace – Staying Connected”, 17-20 November 2020.

Nitrosamines in medicinal products – After valsartan, ranitidine now metformin!

Press release BfArM October 16, 2020

The EU supervisory authorities require nitrosamine tests on medicinal products containing metformin.

„The European Medicines Agency (EMA) and the responsible national authorities in the EU will contact all marketing authorization holders of metformin-containing medicinal products and ask them to test all metformin-containing finished medicinal products for the presence of nitrosamines before they are released to the market.

Covid-19 outbreak – AZ-Biopharm can support you in drug manufacturing, QC and drug development

Meanwhile almost all countries are affected by the virus spread putting many especially elderly people on high risk to die. And although in a few countries one observes that the infection rates are slowing down and scientists around the world are doing a great job to discover a vaccine, there is no mid-term solution for an effective vaccine on the horizon.

COVID-19 VIRUS OUTBREAK

With the outbreak of the Covid 19 virus, we are now facing a pandemic in Europe. At AZ-Biopharm we have taken strict measures in accordance with our social and business responsibility. In the first place, of course, is the general public health of our employees, partners and visitors. As an active and system-critical actor in public health care, AZ-BIOPHARM has taken the following measures to contain the spread of viruses and the safety of everyone:

AZB renews GLP certificate

We would like to inform our customers that AZ Biopharm GmbH has successfully renewed their GLP status. You can continue to have your GLP-required analysis analyzed by AZ Biopharm.

Download GLP certificate

Successful FDA registration

We would like to inform our customers that AZ Biopharm GmbH is now FDA registered. You can have your products analyzed for the US market from now on at AZ Biopharm.

AZB implements new highly sensitive UHPLC-MSMS system

AZ-Biopharm has strengthens its ability to quantify drugs and metabolites to a much lower LLOQ with less efforts for sample preparation by acquiring a brand new SCIEX QTrap 6500+ mass spectrometer. The instrument will allow to support highly potent drug candidates with bioanalytical data from early phases through the entire life cycle process. In combination with UPLC it will allow not only to make drug assay much more sensitive but also to increase speed and selectivity of sample analysis. AZ-Biopharm is looking forward to support our current and future customers with this new era technology.

AZ-Biopharm successfully registered in Scientist

Dear customers,
we would like to announce that AZ-Biopharm has been successfully registered in Scientist (www.scientist.com) and can be charged by our clients without putting in advance separate confidentiality agreements and work orders in place. Using Scientist.com will allow our customers to place work more quickly and with less paper work at AZ-Biopharm GmbH in order to achieve shorter response times.

Management change at the Analytisches Zentrum Biopharm GmbH

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New talents wanted

AZB GmbH is looking for a chemical laboratory technician, CTA / biology lab technician, BTA for our pharmaceutical quality control. More information can be found here.

Implemented new methods and devices for water determination (Karl Fischer Titration) and particle counting

AZ Biopharm GmbH is able to carry out the particle counting according to Pharm. Eur. 2.9.19 by laser light blockade as well as the coulometric titration according to Pharm. Eur. 2.5.32. If you are interested, we look forward to your inquiry to info@az-biopharm.de.

Meet us at the EBF 2018 in Barcelona

The colleagues of the AZB GmbH are again numerous represented at the EBF this year. If you would like to meet us, please contact us in advance via info@az-biopharm.de to make an appointment. We are happy to personally present you with suggestions for solutions to your bioanalytical problems or to exchange valuable information.

New assay for menthol determination in hard candies

AZ Biopharm has developed a robust GC-MS assay for the determination of menthol, validated and tested in routine analysis. If you have questions about the assay, contact us at info@az-biopharm.de.

Internship Pharmaceutical Quality Control / Bioanalytics / Quality Management

AZ Biopharm GmbH is looking for new talents in the fields of chemistry, pharmacy, bioanalytics or any other scientific field of study. We integrate trainees in the areas mentioned and give you the opportunity to gain comprehensive insights into a service laboratory in the pharmaceutical industry. By actively participating in a project, you will become aware of whether you can be enthusiastic about our work after completing the internship. We expect committed participation and genuine interest from our interns. If you are interested, send us your application to info@az-biopharm.de.

New assay for the simultaneous determination of 10 vitamin B compounds

AZ Biopharm has developed and partially validated a highly sensitive LC-MS / MS assay for the simultaneous determination of biotin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin, nicotinic acid, pantothenic acid, cyanocobalamin, p-aminobenzoic acid, lipoic acid.

High sensitive assay for the simultaneous determination of ethinyl estradiol and levonorgestrel

AZ Biopharm has developed and validated a high sensitive LC-MS/MS assay for the simultaneous determination of ethinyl estradiol and levonorgestrel and applied successfully to a bioequivalence study.

New website online

We are pleased to announce that the new AZ Biopharm website has now been launched and we hope you enjoy visiting it!

AZ-Biopharm receives GMP certification from the Berlin Regional Office for Health and Social Affairs

We are pleased to inform you that the GMP certificate for Analytischen Zentrum Biopharm GmbH Berlin has been extended for a further 3 years.
On 21 August 2015, for the second time running, the responsible regional authority (Berlin Regional Office for Health and Social Affairs) extended the GMP certificate for Analytischen Zentrum Biopharm GmbH Berlin for another 3 years.

Since 2002 we have been providing our pharmaceutical services with the highest quality standards and work under the supervision of the authorities in accordance with the GLP and GMP specifications.