Pharmaceuticals

abstract scientific background

Benefit from more than 20 years of experience in GMP analysis!

4base lab maintains GMP compliant laboratories for molecular analysis for more than 20 years. As a reliable partner of mRNA/DNA vaccine manufacturers, 4base lab offers safety at every stage of the manufacturing process. Individual advice and flexible adaptation of our test systems are our strengths. (GMP confirmation is available)

DNA sequencing (Sanger): The confirmation of sequence identity is an essential part of the production of therapeutic nucleic acids. 4base lab offers an extremely reliable GMP sequencing service covering all steps necessary for the determination of complete sequences.  Even samples with low DNA concentrations can be sequenced under GMP using validated rolling circle amplification methods.

RNA sequencing: The confirmation of sequence identity is an essential part of the production of mRNA vaccines. 4base lab offers a highly reliable GMP sequencing service that covers all the necessary steps for determining complete sequences, starting with RNA.

Determination of minimum p(A) length: Determination of minimum poly(A) length in mRNA vaccine molecules using in-house GMP procedures.

Biodistribution analysis: Using specially developed real-time qPCR procedures, the persistence and distribution of therapeutic nucleic acids in different tissues is analyzed. Our team has many years of experience in the planning, development, validation of suitable assays and in the execution and analysis of distribution studies under GMP conditions.

Contamination analysis: Detection of residual DNA contamination. Safety at every step of your manufacturing process of mRNA vaccines. Various qPCR protocols are already established for E. coli and plasmid residual DNA 

Development and Validation: New detection systems can be developed and validated at any time according to customer requirements.