Berlin Metropolitan Area
Subject Matter Expert on Oligonucleotide Manufacturing and Analytics. I offer 40 years of technical expertise and practical experience in oligonucleotide manufacturing, quality control and downstream purification and isolation, facility design and setup (non-GMP small-scale facilities + GMP large-scale facilities), collaboration with contract manufacturers, development of CMC control strategies, and much more... In detail: Manufacturing (Synthesis, Analytics, Downstream) of DNA, RNA, 2'-o-Modifiers, Aptamers, Antisense 1st, 2nd, 3rd xth generation, Gapmers, long and complex oligonucleotides, siRNA, miRNA, mRNA, Ribozymes, Immune-stimulatory oligos (CpG), Transcription Factor Decay (TFD), you name it; Development and project management for oligonucleotide-based therapeutics; Process Development, Process Design, Process Optimisation, Scale-Up from bench to multi kilogram scale, Troubleshooting, Technology Transfer, DoE, CMO selection, CMO & proposal discussions, Supervision of Manufacturing campaigns and Batch Record reading; Customised and tailored programming of GE Healthcare Unicorn control software for oligonucleotide synthesis instrumentation (AKTA oligopilot 10/100, OP400, Oligo Process, Asahi Kasei Technikrom synthesiser), purification, analytical and desalting systems; Instrumentation Selection, Facility Design for Oligonucleotide Manufacturing at any scale, Facility Audits, CMO Audits, Instrument and Process Validation and Qualification (IQ/OQ, PQ, DQ); Theoretical and practical workshops on all above mentioned fields;
Technical Managing Director for planning and commissioning of the new LGC/Axolabs site in Berlin
CMC-Consultant for Oligonucleotide Therapeutics w/40yrs experience. Subject Matter Expert (SME) in the field offering on-site hands-on workshops on Oligonucleotide Synthesis, Analytics, Purification and Downstream; Development, Optimisation, and Stream-lining of manufacturing processes for oligonucleotides from bench to kilogram scale; Process assessment & troubleshooting; Impurity assessment and profiling; CMO-Assessment; Quality Audits; GMP facility design for synthesis scales between 1µmol HTS - 4M GMP; Training of operators and lab personnel in oligosynthesis chemistry and instrument handling; Programming of Unicorn controlled instrumentation; Technology transfer & assessment in the oligonucleotide world; Instrument installations, DQ/IQ/OQ/PQ; High-level trainings; Dossier writing (Module 3), etc. ... you name it.
The DNA-TRAP project is designed to facilitate the exchange of knowledge and technology between 2 leading European research organisations and 2 SMEs (Small and Medium Enterprises) each with an interest in researching the fundamental properties of nanostructured drug delivery systems. For more info see: http://dnatrap-iapp.eu/overview/