Process Creation

Process creation establishes a basic lab-scale process for the manufacture of preclinical and early clinical material.

At this stage Avecia’s novel technologies such as pAVEway™, combined with the impact of our cumulative process R&D experience, really do make a difference. Our goal is to establish quickly a process to support early-phase clinical work whilst ensuring a basis for fast scale-up and long-term quality and cost-of-goods. Our intent is to build ‘validatability’ into the process from the very start.

The starting point may:

• build upon early work clients have undertaken themselves
• commence with just a gene sequence and require application of our extensive molecular biology capability

Building on our experience and a series of well established core protocols, we have the basis for identifying a base fermentation process for yeast or bacteria and understand both the future scale-up potential and the best route through to GMP fermentation at large scale.

Fermentation and Cell Science

We have substantial experience in the development of expression constructs and optimisation of expression systems in:

• Microbial Systems
  • E.coli
  • Pichia sp.
  • Saccharomyces sp.

In particular, we have access to a wide panel of microbial constructs including our award-winning pAVEway™ Advanced Protein Expression System (see Technologies).

For details of our cell banking services click here.

Process Science

Although many of the basics of separation and purification are well established, selecting, modifying and applying an optimum combination alongside other less well known approaches such as expanded bed chromatography, supported by Avecia ‘know-how’, provides a fast route to establishing a robust and scaleable downstream purification process.

Formulation

Biologics brings with them a series of unique issues when establishing formulations that are stable and underpin good product delivery and performance. Further the ground rules are not well defined and experience again comes to the fore in quickly identifying the best strategy and development programme to follow. Avecia has established this capability and by operating in parallel to process development, the impact of changes can be managed and both process development and product formulation can be done in an informed way.