Our Formulation Development team offers services to develop customized formulations for different biologics, such as monoclonal antibodies, bi-specific antibodies, single-chain antibodies, nano antibodies, recombinant proteins, and fusion proteins . Key capabilities include filling process and formulation characterization (DoE), molecule developability and high concentration formulations.
Fast-track platform to support biologics’ developability evaluation.
Pre-formulation and formulation to support clone selection, process development and degradation pathways identification.
Rapid buffers and excipients screening by DSC, particle counting and/or spectrometry.
Container/closure selection and integrity test.
Filling process development, including freeze-thawing, dilution and mixing, holding times, filtration, filling rate and so on. Technical transfer and scale-up to support for GMP fill- & finish.
Long-term, accelerated, in-use stability and forced degradation studies will carried out base on the policy from ICH, ChP and so on.
Lyophilization process development.
Buffer:20 mM His & His-HCl buffer, pH 6.0
Condition:adjust these samples to 10 mg/ml. Added 10 ml to a concentration tube (sartorius 30KD PES), and centrifuge it for 4000×g, each 5 min (flush the membrane by peptide for each timepoint). Tested the exchange buffer weight and concentration.
Buffer:20 mM His & His-HCl buffer, pH 6.0
Condition:concentrate these samples to 20 mg/ml. The resulting solution was spiked (10 µl sample）into the well containing 20 mM His & His-HCl buffer with varying levels of PEG to the final protein concentration of 1mg/ml. Then incubated overnight and inspection of appearance and concentration.
The viscosity, aggregation, self-association may increase due to the increasing of protein concentration, and may effect the below process steps.
Step 1
Developability Study
Bioworkshops Platform method
PEG-Induced, AC-SINS(Affinity Capture Self Interaction Nanoparticle Spectroscopy), e.g.
Step 2
Formulation Development
Pre-formulation
Excipient and Surfactant Screen
Formulation confirmation (3 Months)
Generate materials for pre-clinical development
Formulation Development Report
Step 3
GMP DP Manufacturing
Fill-Finish
Inspection & Package
Storage
Fully validated aseptic processing
Media Fill for custom primary packaging if need extra line to balance the text
