Biosimilar Formulation & Engineering Batch Programme
India (sponsor confidential) · Innovator & Biotech
Overview
Development-stage support for a monoclonal antibody programme: excipient screening against aggregation, then engineering fill-finish batches in vials under cold chain.
The challenge
The sponsor's drug substance showed aggregation above 2% after four weeks at accelerated conditions in the original buffer system, which would not have supported a 24-month shelf life claim.
What we did
Twelve buffer and surfactant combinations were screened with SEC and sub-visible particle monitoring at 2, 4 and 8 weeks. A histidine-trehalose-polysorbate system held aggregation below 0.7% at 8 weeks accelerated. Two engineering batches were filled under 2-8 °C control with the sponsor's analytical methods transferred and run in parallel.
Project data
| Formulations screened | 12 buffer/surfactant systems |
|---|---|
| Aggregation at 8 weeks accelerated | 2.1% → 0.7% |
| Engineering batches | 2, vials, aseptic, cold chain |
| Analytical transferred | SEC, CEX, CE-SDS, sub-visible particles |
| Stage | Development only — no marketing authorisation implied |
| IP position | Sponsor retained cell line, process and data |
Standards applied
- ICH Q5C
- ICH Q1A(R2)
- EU-GMP Annex 1
Scope supplied
- Biosimilar Programmes
- Formulation Development
Related
- Biosimilar Programmes
- Formulation Development