Having completed process characterization for our lead ASO candidate, we have achieved a greater understanding of the process, its capabilities to ..
clear process and product related impurities and understand the mechanisms that control the chromatography. On the manufacturing side, Biogen recently completed at scale PPQ validation batches of an ASO clinical candidate. Cases studies and learnings will be presented on results from characterization studies and PPQ batches. Robert Gronke is a Senior Principal Scientist in the Antisense Oligonucleotide department at Biogen, Inc. For the past 31 years, he’s been involved in the purification process development, CMC team leadership, regulatory liaison and new technology assessments for recombinant biopharmaceuticals including Biogen’s commercial products AVONEX (Interferon Beta-1a), a serum-free version of AVONEX, PLEGRIDY (PEG IFN Beta-1a), BENEPALI (Enbrel biosimilar), SPINRAZA (SMA antisense oligonucleotide), APROLIX (Factor IX-Fc), and AMEVIVE (glycosylated fusion protein), along with more than 20 clinical products including monoclonal antibodies, fusion proteins, glycoproteins, antisense oligonucleotides, and conjugates. Rob currently manages a group of 5 associate scientists.
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