Process Development
-
We make it work -
for every molecule -
Our development experts with extensive experience in molecule development are dedicated to ensuring your smooth transition from discovery to clinical.
Based on the comprehensive understanding of each molecules’ unique characteristics, our team identifies highly effective end-to-end process and manages a seamless transition while completing the Cell Line Development (CLD) at the same time.
Standard Timeline
Cell Line Development
- Process Development (3.5 months)
-
- Upstream Process : Analytical Tech Transfer, cGMP DS Lot Release
- Downstream Process : cGM P DP Lot R elease
- Formulation : Non-GMP DS/DP, cGMP DS, cGMP DP
- Analytical Method
Documentation for IND Filing
Process Development
-
-
Upstream Process
-
We take pride in our USP team's track record of successfully cultivating a diverse range of molecules in our state-of-the art high-throughput lab. Our team of experts is committed to delivering high-quality results at speed and has extensive experience in optimizing upstream process development to meet the unique needs of our clients.
Upstream Process
- Molecule information / cell bank transfer
- Basal Media Screening in shake flask
- Feed Media Screening in shake flask
- Process optimization in Ambr 15TM
- Process verification run in 2L STR
-
-
-
Downstream Process
-
Our DSP team is equipped with pioneering lab capabilities and up-to-date techniques. In addition to our expertise in DSP, we have also developed a streamlined scheme for non-GMP toxicology manufacturing, help steering your development journey.
Downstream Process
- Preparation for DSP Development
- Column Process Development
- Virus Inactivation Process Development
- Filter Process Development
- Process verification run in AKTA
-
-
-
Formulation
-
Our formulation team is filled with high-quality subject matter experts (SMEs) who are leading the latest techniques and industry trends. Our commitment to exceeding our customers’ expectations is at the forefront of everything we do.
Formulation
- Liquid Formulation
- Lyophilization Development
- Non-GMP Manual Filling
-
Analytical Method
-
With a well-developed strategy for method development and a high performance, our analytical method development team is dedicated to delivering reliable results possible. We use state-of-the-art instrumentation and the latest techniques to ensure the quality of our analytical data.
Analytical Method
- A nalytical Method Development
- Extended characterization & comparability studies
- Analytical Support
-
Process Development
- Upstream Process
-
We take pride in our USP team's track record of successfully cultivating a diverse range of molecules in our state-of-the art high-throughput lab. Our team of experts is committed to delivering high-quality results at speed and has extensive experience in optimizing upstream process development to meet the unique needs of our clients.
Upstream Process
- Molecule information / cell bank transfer
- Basal Media Screening in shake flask
- Feed Media Screening in shake flask
- Process optimization in Ambr 15TM
- Process verification run in 2L STR
- Downstream Process
-
Our DSP team is equipped with pioneering lab capabilities and up-to-date techniques. In addition to our expertise in DSP, we have also developed a streamlined scheme for non-GMP toxicology manufacturing, help steering your development journey.
Downstream Process
- Preparation for DSP Development
- Column Process Development
- Virus Inactivation Process Development
- Filter Process Development
- Process verification run in AKTA
- Formulation
-
Our formulation team comprises plenty of high-quality subject matter experts (SMEs) who are well-versed in the latest tech-niques and industry trends. Our commitment to exceeding our customers’ expectations is at the forefront of everything we do.
Formulation
- Liquid Formulation
- Lyophilization Development
- Non-GMP Manual Filling
- Analytical Method
-
With a well-developed strategy for method development and a high performance, our analytical method development team is dedicated to delivering reliable results possible. We use state-of-the-art instrumentation and the latest techniques to ensure the quality of our analytical data.
Analytical Method
- A nalytical Method Development
- Extended characterization & comparability studies
- Analytical Support