PHASE APPROPRIATE PROCESS AND ANALYTICAL DEVELOPMENT
We develop scalable and robust processes supported by development of analytical methods
- USP and DSP using DOE and scale-down model.
Development is adapted to the requirements of each vector and is phase appropriate
- To meet your overall projects timelines, we define with you an early phase process that can be scaled up to phase 3 and commercial with minor modifications.
- Our aim is to overcome your CMC challenges by helping you to select the appropriate technologies to develop/perform right the first time, thus meeting your Target Product Profile (TPP).
Seamless transfer from Process Development to GMP manufacturing
- At ABL we have put in place an organization in which the same experts are involved in both process development and the support of the GMP manufacturing. We are convinced that it allows us to reduce the overall project timelines and risks related to technology transfer.
At ABL we consider analytical development and transfer as key to ensure the success of your projects
- Analytical testing is often on the critical path of the CMC; ABL has set up a highly skilled and experienced QC Department equipped to develop and perform in-house all the required product specific testing, release and stability assay.
TECH TRANSFER AND DEVELOPMENT
Seamless technology transfer and development
- Dedicated Project Management after commitment
- Technology Transfer Team
- Process Development
- Upstream (adherent, suspension, microcarriers)
- Downstream
- DOE and Scale-Down Model
- Analytical Development
- Cell Line adaptation (adherent to suspension or microcarriers, serum free)
- WCB, WVS, MCB, MVS
- Media and Buffer Optimization
- Analytical Qualification and Validation
- Process Characterization and Validation
- DS and DP Stability Testing