Visionary Pharma Consulting LLC
Consulting with Vision
Biologics/Pharmaceuticals
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Publications

  1. A. G. Lolas, B. Chi, P. F. Hughes, and K. Suvarna. CMC Microbiology Review of Biologics License Applications and Pre-License/Pre-Approval Inspections: Therapeutic Biological Proteins. 2010. American Pharmaceutical Review 2:56-60. 
  2. A. G. Lolas and J. W. Metcalfe. Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design. 2011. PDA Journal of Science & Technology 65(1): 63-70. 
  3. K. Suvarna, A. Lolas, P. Hughes, and R. L. Friedman. Studies of Microbial Contamination in Biologic Product Manufacturing. 2011. American Pharmaceutical Review 1: 50-56. 
  4. A. Lolas. PDA/FDA Serves as Platform for Agency to Announce Initiatives, Industry to Comment. 2011. PDA Letter 47(10): 36-38, 44. 
  5. A. Lolas. cGMP Standards for Quality Assurance and Inspection Management. Part 2: Chapters 1-6 in Comparison of the Compliance Method (PIC/S, FDA, Japan, EU), and Inspection (Japanese title: [日本・欧州(PIC/S)・アメリカ] 各国GMP要求の徹底比較・適合方法と査察対応). 2012. Science & Technology. 
  6. A.G. Lolas and A. S. Rathore. Regulatory Challenges in the QbD Paradigm. 2012. BioPharma International 25(9): 44-53. 
  7. A.G. Lolas. Application of Rapid Microbiological Methods in BioProcessing and Regulatory Considerations edited by Dr. Michael Miller. January 2013. PDA & Davis Healthcare International Publishing. 
  8. A.G. Lolas. Microbial Control Strategies in Bioprocessing Falling Short of Assuring Product Quality and Satisfying Regulatory Expectations. 2013. American Pharmaceutical Review 16(2): 20-31. 
  9. A.G. Lolas and I. Uydess. State of Quality and Compliance in the Biopharmaceutical Industry. 2013. BioPharm International 26(4): 16-19. 
  10. A.G. Lolas. The Role of Microbiology in the Design and Development of Pharmaceutical Manufacturing Processes. 2014. Pharmaceutical Bioprocessing 2(2): 125-128.
Anastasia Lolas has presented at several conferences: 2014 BioProcess International Conference & Exhibition (Boston, MA, USA), 2013 PDA Europe Pharmaceutical Microbiology Conference (Berlin, Germany), 2012 PMF Conference on Alternate and Rapid Microbiological Methods (Las Vegas, NV, USA), 2011 Lean for Biotechnology Symposium (Columbia, MD, USA), 2008 and 2009 PDA Global Microbiology Conference (Chicago, IL & Bethesda, MD, USA), 2008 International Meeting on Radiation Processing & Drug/Device Workshop (London, UK).