New Method to Directly Sequence Small Genomes Without Library Preparation
For the first time, researchers sequenced DNA molecules without the need for the standard pre-sequencing workflow known as library preparation. Read more here.
FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL® PCR Mycoplasma Detection Kit)
On November 1st, 2012, the MycoTOOL® PCR Mycoplasma Detection Kit-based test from Roche Applied Science was approved by the U.S. Food and Drug Administration (FDA) for release testing of a Roche biopharmaceutical product. More details here.
New guideline for DNA Sequences could prevent erroneous Data
A international team of researchers, with it’s core at the University of Gothenburg, Sweden, has prepared a guide to assist the scientific community in the quality control process. Find out more.
The Vice-Chair of the USP General Chapters – Microbiology Expert Committee, Tony Cundell, recently provided an update to the chapter’s revision process and what we should see when the draft is published in a future issue of the Pharmacopeial Forum. Read more.
Rapid Micro Biosystems announces Availability of Growth Direct System
New applications should improve the efficiency of microbial quality control processes while significantly reducing the time-to-result. More details can be found here.
EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines
The EMA/CHMP published an assessment report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines. More details can be found here.
The Rapid Microbiological Methods database in the member area of our working group was updated with 4 new systems, e.g. for sterility testing and Endotoxin detection. More details can be found here.
EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations
The European Medicines Agency has today agreed on a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis. Read more.
Dr. Claudius Micha Nübling becomes Member of the RMM Group Advisory Board
Dr Claudius Micha Nübling from the Paul-Ehrlich-Institut became member of the RMM Group Advisory Board. He will follow our longstanding Member Dr Thomas Montag. Read more here.
Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research
The FDA's CBER published their strategic plan for regulatory science and research 2012 -2016. A possible further step for implementation of modern microbiological methods? Read more.
More Flexibility in Sterility Testing of biologic Products – FDA Amendments
Within FDA's scope - to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science, the US authority published amendments to the sterility testing rule. Read more about the background and contents.
FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing
In June, the FDA has published a new Question and Answer Guidance for Endotoxin and Pyrogen Testing. It should reflect the current thinking of the agency on that topic. Read more here.