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Independent Biotech Consultant | Biotherapeutics Manufacturing | acuity-biotech | home

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. Through laboratory scale studies. Process development, validation and scale up,. Clinical trial manufacture,. CMC data preparation and section preparation,. Lean sigma 6,. CGMP manufacturing, microbial and mammalian cells,.

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Stephen Berezenko

43 Bel●●●●●●d Road

Walton-on●●●●●●●●●adlincote , DBY, DE12 8NF

UNITED KINGDOM

4412●●●●3239
st●●●●●●●●@hotmail.co.uk

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Independent Biotech Consultant | Biotherapeutics Manufacturing | acuity-biotech | home | acuity-biotech.com Reviews
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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. Through laboratory scale studies. Process development, validation and scale up,. Clinical trial manufacture,. CMC data preparation and section preparation,. Lean sigma 6,. CGMP manufacturing, microbial and mammalian cells,.
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1 acuity biotech
2 expertise covering
3 from discovery
4 to commercial production
5 expertise
6 biosimilar development
7 analytical method development
8 and validation
9 cmo management
10 deviation investigation
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Independent Biotech Consultant | Biotherapeutics Manufacturing | acuity-biotech | home | acuity-biotech.com Reviews

https://acuity-biotech.com

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. Through laboratory scale studies. Process development, validation and scale up,. Clinical trial manufacture,. CMC data preparation and section preparation,. Lean sigma 6,. CGMP manufacturing, microbial and mammalian cells,.

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acuity-biotech.com acuity-biotech.com
1

Biotech Consultant | S Berezenko | Expertise

http://www.acuity-biotech.com/index-2.html

Lean Sigma 6 Green Belt. Team leader resulting in successful technology transfer to Japan resulted in the Japanese company investing in and building a recombinant protein production plant. Experienced in the input required to support the successful regulatory submission of recombinant proteins. Management of international groups of staff from Germany, Japan and USA to complete the development and manufacture of recombinant proteins for animal toxicology and efficacy studies. Bioprocess Validation UCL, MBI.

2

S Berezenko | Biography | acuity-biotech

http://www.acuity-biotech.com/index-3.html

Independent Consultant 2010 - To date. Independent consultancy for various organisations on process development and recombinant protein manufacture. Cerenis Therapeutics, VP Operations, Toulouse, France 2008 - 2010. Novozymes Biopharma Ltd, Nottingham, UK 1988 - 2007. Novozymes AS, Denmark, acquired Delta Biotechnology in July 2006 from Sanofi Aventis. Research and Development Director 2001 - 2007. Technology Transfer Manager 1999 - 2001. Management of technology transfer to Europe, Japan and USA.

3

S Berezenko | Publications | acuity-biotech

http://www.acuity-biotech.com/index-4.html

Berezenko, S.,. WO 1996037515A1 - Process of high purity albumin production. Berezenko, S and Ballance, D.J. (1997) 8th European Congress of Biotechnology, Budapest. Purification of Recombinant Human Albumin: an integrated bioprocess. Berezenko, S.,. United States Patent 6,034,221; High purity albumin. EP 201960, High purity albumin production by a multi step process. Ballance, D.J.,. WO 200044772, Purifying recombinant albumin for use in the treatment of burns, shock and blood loss. Berezenko, S.,.

4

S Berezenko | Selected Presentations | acuity-biotech

http://www.acuity-biotech.com/index-5.html

Biologics Manufacturing Summit, London, 2004, A case study in strain and process development. BIO, Philadelphia, 2005, Novel Solutions to Yeast Recombinant protein Expression. Technology Transfer for Biopharmaceuticals, Amsterdam, 2006, Designing an Effective Formulation for the Manufacture of Recombinant Albumin. Bioprocess International, Prague, 2006, Novel Solutions to Recombinant Protein Expression in Yeast. The end result of technology transfer,. Lean Sigma 6 Training, Firebrand.

5

Independent Biotech Consultant | Biotherapeutics Manufacturing | acuity-biotech | home

http://www.acuity-biotech.com/index.html

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. Through laboratory scale studies. Process development, validation and scale up,. Clinical trial manufacture,. CMC data preparation and section preparation,. Lean sigma 6,. CGMP manufacturing, microbial and mammalian cells,.

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