Catalog #3000 - Developability Package 3
Title:
Developability Package 3
Description:
Developability Assessment – Package 3
Scope:
Formulation and Stability Testing Package Workflow
- Buffer formulations
- Stress Conditions
- Assays
Task 1. Buffer Formulations
A total of six (6) buffer formulations will be chosen. Curia has a standard panel of formulations ranging from pH 5 – 7
that were chosen based on common formulations used for commercial antibodies. Client may opt to choose their own
buffers for testing. Special/custom reagents and buffers may be charged to client as material costs.
Task 2. Stress Conditions
The protein will be subjected to a total of three (3) conditions. The protein will also be characterized immediately after
buffer exchange.
- After buffer exchange (T0)
- No-stress: storage at 4°C for 28 days.
- Thermal stress: incubation at 40°C for 28 days
- Freeze/thaw stability: 5 cycles of freeze/thaw
In addition, an aliquot from each stress condition will be sent to the client for binding and/or functional testing.
Task 3. Assays
The protein will be characterized by the following assays immediately after each specified condition:
- Thermostability analysis by DSF/DLS using UNcle
- Only 2 conditions: before buffer exchange, after buffer exchange
- Post-translation modification by mass spectrometry
- All 5 conditions: before buffer exchange, after buffer exchange, no-stress, thermal, freeze/thaw
- Aggregation analysis by SE-UPLC
- All 5 conditions: before buffer exchange, after buffer exchange, no-stress, thermal, freeze/thaw
- Purity analysis by CE-SDS (R/NR)
- All 5 conditions: before buffer exchange, after buffer exchange, no-stress, thermal, freeze/thaw
- Charge variant analysis by cIEF
- All 5 conditions: before buffer exchange, after buffer exchange, no-stress, thermal, freeze/thaw
Deliverable:
Study Report including data deck
Material Required:
- Antibody heavy and light chain sequences
- 10 – 20 mg of purified antibody at ≥ 1 mg/mL
- Project Initiation Fee
Timeline:
6 weeks
Price:
Request
