The level of core fucosylation on therapeutic antibodies have major impact on antibody dependent cell cytotoxicity. To study the core fucosylation, Suli Liu and Li Zang at Biogen have published a method using deglycosylation by GlycINATOR, reduction of the antibody and LC-MS analysis. Using this methodology the scientist could quantify the fucosylation within 1 h, including sample preparation and analysis. Liu and Zang argue that this methodology is particularly well suited for high-troughput analysis cell line development and process development of therapeutic mAbs.
Genovis has reached a settlement in its patent infringement lawsuit with Promega Corp. and agreed to a royalty bearing, worldwide license to the patents-in-suit.
The settlement ends all ongoing patent-infringement claims between the parties and Promega has agreed to a royalty bearing, worldwide license to the patents-in-suit, thereby ending the lawsuit between the parties. The specific terms of the contract are confidential.
“I am pleased we were able to reach a settlement with a favorable business solution that accommodates Genovis’ long term growth strategy,” says Fredrik Olsson, CEO of Genovis.
The FabULOUS (SpeB) enzyme digests IgG in the hinge region. The FabULOUS Fab kit is designed for digestion and purification of Fab fragments from mouse IgG antibodies. Incubation at optimized reducing conditions generates intact Fab, easily purified with spin columns.
- Digestion in the hinge with FabULOUS
- Affinity purification of Fab fragments using the light chain
- Preparation of Fab fragments from mouse IgG in less than 2 h
The Genovis team has published a review on FabRICATOR (IdeS) characterization of therapeutic antibodies
The Genovis team has together with Alain Beck, Senior Director Antibody Physico-Chemistry at Pierre Fabre, published a review article summarizing all the current publications using FabRICATOR (IdeS) for characterization of therapeutic antibodies and related products.
“The specificity and robustness of the IdeS digestion is critical for generating a homogenous pool of fragments. Combined with the limited sample preparation and ease of data interpretation, the IdeS enzyme has transformed antibody subunit analysis” Sjögren et al. 2016.
The review is published in The Analyst and demonstrates the wide use of FabRICATOR to study critical antibody qualities such as:
- Drug antibody ratio on ADCs
The FabRICATOR enzyme specifically digests antibodies into F(ab’)2 and Fc/2 fragments that can be reduced to antibody subunits (Fd, LC and Fc/2) and studied with high mass accuracy.
Researchers at the University of Geneva led by Davy Guillarme has used a novel form of HPLC column, based on wide-pore hybrid silica bonded with amide ligand, and developed an HILIC analytical workflow for characterization of biopharmaceuticals. The scientists used FabRICATOR to fragment trastuzumab to subunits and studied the fragments using the new column with HILIC separation. The results showed that the method effectively separated important glycoforms of the Fc/2 fragment. The developed method is compatible with mass spectrometry, does not need high mobile phase temperatures, and allows serial coupling of columns.
Genovis expands the protease portfolio with GingisREX – a new enzyme with unique specificity for arginine residues. The GingisREX protease can be used for peptide mapping, protein sequencing and post-translational modification analysis using mass spectrometry.
New references on IgG glycosylation, glycation and ADC characterization using IgGZERO and FabRICATOR
New references are out using Genovis enzymes to study antibody glycation, pairing of high-mannose glycans and ADC characterization using CE-MS.
The cooperation agreement will provide Genovis with access to Alphalyse’s expertise in mass spectrometry while Alphalyse will have the opportunity to offer its customers analyses based on Genovis’ unique enzymes for antibodies and other pharmaceutical proteins. Read more »
To develop an antibody based PET imaging for detection of amyloid beta in mouse models, Sehlin and colleagues at the Rudbeck Laboratory in Uppsala, Sweden, used Fabricator to generate F(ab’)2 fragments. In the study, published in Nature Communications, Sehlin et al. generated F(ab’)2 fragments using FabRICATOR of an amyloid beta specific antibody and conjugated this to a transferrin receptor antibody for delivery across the blood brain barrier. Read more »
Genovis is launching a further development of GingisKHAN® that will be marketed under the name GingisKHAN®Fab kit. The product will be presented at the conference Antibody Engineering & Therapeutics in San Diego next week. Read more »