3P Biopharmaceuticals develops biologics in mammalian, yeast, and bacterial systems (GMP conditions when required).

The R&D Department gains specific expertise in the technological fields of cloning, expression, fermentation, protein folding, purification, and analytical testing.

Generation of expression systems

3P Biopharmaceuticals provides transient and stable cell line generation services for recombinant proteins in mammalian, yeast or bacterial organisms.

 

generation

MICROBIAL: E.Coli, S. Cerevisiae, H.Polymorpha, P. Pastoris

MAMMALIAN: CHO, BHK, HEK, Hybridomas

Protein expression services are developed using either IP-free strategies or proprietary technology based on Semliki Virus Vector system.

 

How we generate protein expression systems

 

Biosynthesis development

3P Biopharmaceuticals´R&D Department supports development and optimization of processes offering batch, high cell density fed-batch fermentation, and perfusion, including medium and feeding strategy.

By evaluating critical parameters of the process, such as related impurities control from the early beginning, the Process Validation team ensures successful scale-up and tech transfer.

 

        

Purification development

3P Biopharmaceuticals supports the development of different biologics (innovative, bio-superiors and biosimilars) defining a robust, scalable, time and cost effective process in compliance with regulatory requirements.

R&D Department supports the development of purification, covering different steps of process, such as effective and well-controlled refolding, tangential flow filtration, chromatography media selection and optimization, virus inactivation, and filtration.

By evaluating critical parameters of the process, such as related impurities control from the early beginning, the Process Validation team ensures successful scale-up and tech transfer.

 

Purification Development

Analytical development

3P Biopharmaceuticals provides characterization through the combination of well-known traditional and new proteomic techniques to obtain scientifically reliable biologics.

Effective development and qualification of analytical and bioanalytical methods for end product testing (API and final drug product) is developed in compliance with regulatory requirements.

In-process control, which consists of ensuring effective monitoring and control for process, product related impurities, and excipients is performed as well as stability-indicating methods.

Analytical Development

Formulation development

3P Biopharmaceuticals provides formulation development services consisting of:

  • Screening different additives for API or final drug product.
  • Proposing appropriate devices or delivery systems.
  • Adjusting or developing new stability-indicating methods.
  • Performing stability studies of selected formulations under accelerated and stress conditions.