Download Antibody Humanization Workflow And Price List

Humanization workflow:
1) Fv modeling
- 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
2) Humanization design
- Up to 5 humanized VH and 5 humanized VL versions will be designed
respectively following INN new rule
- Coden optimization (optional)
3.1) First round of leads selection and production:
- 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 (1mg
each)
3.2) Production of all humanized versions plus chimeric Ab as the control
- 2mg protein for each sample
4) Second round of final humanization lead selection
a) Affinity: Biacore or cell based assay (such as FACS, if Biacore is not
applicable)
b) Aggregation potential: DLS
c) Thermostability: DSC
d) Purity: SEC or CE
e) Non-specific binding (ELISA on Baculovirus) with in-house controls
Price list, payment method and time line:
Package A: Golden Design ($20,000)
1) + 2)
Upfront payment: $12000
Design fee payment: $8000
Design starts after receiving the upfront payment, 2 weeks after receiving the
payment, an antibody humanization report include:
- Fv models
- Schordinger aggregation surface prediction
- Schordinger PTM analysis,
- 3D based PI prediction
- Human template information
- Humanization percentage of each VH and VL version
- Optimization interpretation (if any)
will be sent to the client. If the client is satisfied with the report, please pay the
remaining service fee ($8000) in two weeks. After receiving the final payment,
sequences of all humanized VH and VL versions will be sent to the client via
email in 2 days. If needed, the designer will provide clients free email
consultation service within 2 months after the sequences are received by the
client.
Package B: Gold design + Preliminary screening ($40,000)
1) + 2) + 3.1)
Upfront payment: $12,000
Preliminary screening payment: $15,000
Design fee payment: $8000 to $10,000
Golden design service starts after receiving $12,000 upfront payment. Design
report (without sequence information) will be sent to customer in 2 weeks.
Preliminary screening will be performed after clients approve the design and pay
$15,000 service fee. Preliminary screening data will be sent to clients in 6 weeks.
One week after the data is received by the client, $8000 remaining design fee and
$5000 protein production fee need to be sent to Ab Studio. After receiving the
final payment, Ab Studio will send to client humanized sequences information and
1mg/sample of purified chimeric antibody as well as that of 2-3 leads selected by
the client in 6 weeks.
Package C: Gold design + Protein production ($40,000)
1) + 2) + 3.2)
Gold design service payment: $20,000
Protein production payment: $20,000
After Golden design service is done, if clients want to get purified proteins for
characterization, $20,000 will be charged for producing 9 humanized versions and
1 chimeric antibody control at 2mg per sample in 8 weeks. Both designed
humanized sequences and purified proteins will be delivered to the client after
the full payment is received.
Package D: Diamond full humanization service ($70,000)
1) + 2) + 3.1) + 4)
Upfront payment: $12,000
Preliminary screening payment: $15,000
Design fee payment: $8000
Protein production payment: $15,000
Secondary screening payment: $20,000
Humanization design starts after receiving $12,000 upfront payment, design
report without sequence information will be sent to client for approval in 2
weeks. After clients approve the report and pay $15,000 preliminary screening
fee, preliminary screening will start and complete in 6 weeks. Screening data will
be sent to clients for review and approval. One week after clients review and
approve the report and select the leads for second round screening, $8000 design
fee as well as $15,000 protein production fee (for producing 2 humanization leads
and chimeric antibody control at 5mg/sample) need to be paid to Ab Studio.
Protein production will complete in 6 weeks. After that, Ab Studio will start the
secondary round screen service after receiving $20,000 service fee from clients.
The secondary round screen service includes Biacore for affinity, DLS for
aggregation, DSC for thermostability, SEC/CE for heterogenecity and Bac ELISA for
non-specific tissue binding. All these data are required for analyzing the
developability of a humanized antibody in CMC processing. These work will be
done in 6 weeks. Both the remaining purified protein and the full humanization
report containing all data as well as humanized sequence information will be sent
to the client after full service fee is completed.