Antibody Humanization And Optimization Service

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Detailed sequence analysis and 3D structure modeling

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Identification of the best human germline sequence templates, grafting the rodent or rabbit antibody CDR regions into the human antibody frameworks

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Identifying back-mutations and remove “hot spots” with developability issues

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High throughput lead selection and evaluation

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Efficient lead preparation for research purpose in house (up to 20mg), CMC level protein preparation at the facility of our CMC partner (http://www.mabventure.com/en/about.php)

Antibody humanization and optimization workflow
Fv Modeling
Humanization and optimization design
First round of leads selection and production
Second round of final humanization lead selection
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Application of Schordinger to build up one Fv homology model and one Fv hetero model

Generate aggregation surface report

Generate PTM analysis report (including N-glycosylation, deamidation, oxidation and protease site analysis based on the displaying status of the amino acid on 3D structure surface)

Generate 3D PI prediction

DNA synthesis, cloning and transient transfection


    Affinity (ELISA) assay with expression media


    Aggregation potential and thermos-stability raw screening (ELISAs after heating) with expression media


    Production of top 3 humanization leads and chimeric antibody (2mg each)


    Non-specific binding assay (ELISA on Baculovirus) with in-house controls
 

Up to 5 humanized VH and 5 humanized VL versions will be designed respectively


    PTMs will be removed if antibody’s affinity and/or developability won’t be significantly affected


    Change of 3D PI and aggregation potential will be marked during the design process, if developability issue is observed on bench, these Information will be applied to fix the developability problem of the humanization lead


    Predicted high risk T-cell epitope, B cell epitope, MHC-II epitope and antigenicity epitope will be recorded.

 

Clients will be informed about the potential complications to remove these epitopes
 

Affinity: Probelife (similar to Octect for detecting kd) or cell based assay (such as FACS, if other methods are not applicable)


    Aggregation potential: DLS


    Thermostability: DSF


    Purity: CE
 

Price list, payment method and time line

Not only success based charge, but also service guarantee based charge!

Humanization and optimization design starts after receiving $20,000 upfront payment, design report without sequence information will be sent to client for approval in 2 weeks. Preliminary screening will start after clients approve the design and pay the $15,000 service fee. Preliminary screening data will be sent to clients in 6 weeks without second round of sequence optimization for affinity (~ 90% frequency) or 10 weeks with second round of sequence optimization for affinity (~ 10% frequency). After the data is received and approved by the client, $35,000 protein production, purification and second round screening fee needs to be sent to Ab Studio. After receiving the payment, Ab Studio will start the secondary round screening service which will take 8 weeks without further sequence optimization for developability (~80% frequency) or 12 weeks with further sequence optimization for developability (~20% frequency). The data from the second round of screening will be sent to client for selecting the final lead sequence. Once the client informs Ab Studio the final lead and sends us $10,000 lead production fee as well as $10,000 remaining design fee, Ab Studio will purify 10mg of the final lead antibody protein and send it to client along with the remaining purified antibodies from first round screening as well as the full antibody humanization/ optimization report (containing all designed sequences)

Significant discounts will be applied for start-ups and/or multiple projects!

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