Process Development

Our vendors have significant experience and expertise in process development, which can boost the batch yield in a shorter timeline. They identify the CPPs and CQAs through an effective Design of Experiment methodology to achieve robust processes and optimized throughput.

• Process development for mammalian recombinant proteins

• Bioprocessing capability

• Fed-batch and perfusion cell culture processes

• Reliable cGMP biologics manufacturing 

• Accurate solutions for FIH trials

• Tested technology transfer experience

• Scalability to commercial manufacturing

 

Analytical Capabilities

Strong analytical capabilities are critical in identifying and characterizing your recombinant protein or antibody, and it’s also essential in the cGMP methodology implementation and data gathering for regulatory purposes. Our vendors have a wealth of knowledge on formulation development and bioprocessing, which will prepare your molecule for formulation at whatever stage. 

 

Analytical services:

• Glycan profiling 

• ELISA assays 

• Residual DNA detection 

• Cell-based bioassays 

• Immunologic and colorimetric assays 

• Chromatography 

• Mass spectrometry

 

Technology Transfer

Together with our preferred vendors, DEP is committed to delivering on time. Therefore, our vendors can execute technology transfers quickly. You may also benefit from a complete validation package in line with cGMP guidelines.

• BLA/PPQ enabling process characterization and validation

• Analytical methods validation

• ICH stability studies

• Container shipment studies

• CMC documentation in CTD format

 

Manufacturing Solutions

Our collaborative network of vendors consists of quality, technical, and customer engagement personnel who work together to meet your project’s goals through efficient logistics. Manufacturing facilities and technologies are ready and maintained while solutions are customized to your needs.

• Clinical labeling services

• Clinical supply optimization

• Clinical trial packaging and storage

• Cold chain storage and logistics

• Distribution and logistics

• Clinical ancillary management

 

DEP assembles only the top vendors with the right people, infrastructure, technology, and processes to handle your large molecules at different stages.