acuity-biotech home

Stephen Berezenko
  • Acuity-biotech...

    Builds on and offers the experience gained by Stephen Berezenko PhD over 25 years in the biotech industry.  Experience that will help to address and solve problems, and offer advice covering a wide range of areas in the research, development, scale-up and production of biomolecules.

  • read more

 

Expertise covering...

Discovery DNA

 

From discovery

 

read more
 

Lab Studies
Through laboratory scale studies
 
 
 

Commercial Scale Purification

To commercial production

read more
 

Expertise

Biosimilar development

Analytical method development and validation,

Process development, validation and scale up,

Clinical trial manufacture,

CMC data preparation and section preparation,

Lean sigma 6,

cGMP manufacturing, microbial and mammalian cells,

Scale up of processes,

Technical transfer to manufacturing facilities,

Documentation, Process Description, SOPs, Batch Records,

CMO management,

Bioreactor scale down modelling,

Deviation investigation,

Root cause analysis,

Preventative Action and Corrective Actions (CAPA), SPC,

Change Control,

Technology transfer, internal and international,

Due diligence

Academic grant application assessment and approvals

 

 

Top of page

 
 

A A A