BPL's Services

 

Production Process development

From clone development to pilot-scale production

Clone development:

  • Optimization of DNA plasmid

  • Transfection/transformation to host

  • Selection of optimal clone

  • Preparation of research cell bank

Expression systems:

  • Mammalian cells

  • Bacterial cells

  • Yeast

  • Algae

​Production:

  • Process development in bench scale

  • Scale up to fermentor or bioreactor scale

​​Purification & formulation:

  • Bench-scale process development

  • Scale up to gram scale process

​Analyses:

  • Development and qualification of:

    • In-process testing methods

    • Release testing methods

    • Characterization methods

Advantages:​ One-stop shop, One contact, Smooth and seamless transfer to GMP production

 

Scale Up - GMP production

From a pilot scale to release for human/clinical use

  • Preparations:

    • Preparation of GMP regulatory package (reports, SOPs, Batch records)

    • Process and testing methods qualification/validation

    • Equipment and facilities qualification/validation

  • Production, purification, formulation

  • Analyses:

    • In-process

    • Release testing

    • Characterization

  • Stability

  • Supply clinical studies

Services are provided from BPL's facility or from alliances, as found appropriate according to regulatory and technological aspects

 

Commercial manufacturing

From GMP production to site registration and supply marketing sales

  • Run to run and batch to batch consistency

  • Facility validation

  • Support preparation of registration file

  • Allow regulatory inspections