Prof. Dr. Hanns-Christian Mahler, Head Drug Product Services
 
Prof.Dr. Hanns-Christian Mahler     

Hanns-Christian Mahler has extensive experience in drug product development and manufacturing. For more than 15 years, he worked for Merck and Roche in leadership roles, most recently as Head of Pharmaceutical Development & Supplies Biologics EU (Roche). Hanns-Christian participated in several product IND/IMPD submissions and numerous market launches for high profile products. He has broad industry experience in parenteral formulation and process development, line extensions, primary packaging development, device development, drug product clinical and commercial manufacturing and transfers.

  

Hanns-Christian studied Pharmacy and holds a Ph.D. from the Institute of Pharmacy at the University of Mainz (DE). In addition, he has Specialist Pharmacist degrees in Pharmaceutical Technology and Toxicology & Ecology from the German Pharmacists Chamber (DE). He made his Habilitation in Pharmaceutical Technologies and is extraordinary Professor for Pharmaceutical Technology at the University of Frankfurt (DE) and adjunct faculty member and lecturer at the University of Basel (CH). Having published more than 60 scientific manuscripts and submitted more than 20 patent filings, Hanns-Christian was elected an AAPS fellow in recognition of his scientific achievements in 2013. He also serves as an expert on EDQM (Ph.Eur) committees and other industry consortia.

     

 

 

Dr. Susanne Jörg, Head Formulation Development
 
Dr. Susanne Joerg    

Susanne Jörg's extensive experience in drug product formulation development includes more than 10 years of leadership roles at Novartis Biologics. She worked on drug products from monoclonal antibodies, recombinant proteins, fusion proteins, bioconjugates, antibody fragments, nanobodies, and antibody drug conjugates for parenterals including intravitreal applications. Susanne has broad experience in liquid and lyophilized early- and late phase drug product development. In collaboration with Merck KGaA , Darmstardt (DE), Susanne developed liquid high-concentration monoclonal antibody formulations, implementation of different concentration and analytical techniques such as ELISA, DSC, FTIR, nephelometry and viscometry, and supported regulatory filings.

 

Susanne studied Pharmacy at the University of Mainz (DE), and holds a Ph.D. from the University of Munich (DE).

     

 

 

Dr. Atanas Koulov, Head Drug Product Analytical Development and Quality Control
 
Dr. Atanas Koulov    

Atanas Koulov brings eight years of industry experience in drug product analytical development and quality control release and stability testing, as well as characterization, investigations support and specification setting to Lonza. His previous roles include managing Roche’s Particle lab, activities for visible, subvisible and submicron particles, as well as responsibility for various programs in Analytical Development & QC of Drug Products. In addition to his roles at Roche, Atanas also worked as a Lab Head, Analytical Development at Novartis Biologics.

 

Atanas has published extensively in the field of protein aggregation and particles and is the immediate past chair of the AAPS Protein Aggregation & Biological Consequences Focus Group. He holds a Ph.D. in Biochemistry from the University of Notre Dame, IN (USA), earned his M.Sc. in Molecular Biology and Clinical Chemistry from Sofia University (BG) and worked as Postdoctoral Fellow at the Scripps Research Institute in San Diego, CA (USA).            

 

 

 

     
 Dr. Satish Singh, Head Drug Product Process Development
       
     

Satish Singh has more than 25 years of experience in biopharmaceutical product development. His expertise includes process development, scale-up and technology transfer and ranges from discovery support  to development, manufacture and final drug product commercialization.

Prior to joining Lonza, Satish was a Research Fellow and Group Leader in Pfizer's Biotherapeutics Pharmaceutical Sciences R&D Unit. Satish has also lead technical teams that focused on particulates, drug substance storage, antibody drug conjugate structure/property relationship, immunogenicity risk evaluation, and the development and application of computational tools in the chemistry, manufacturing and controls (CMC) aspects of biotherapeutics.

 

Satish has a strong technical background and understanding of regulatory challenges and the evolving global regulatory landscape. He has served on a number of USP Expert Panels and other industry consortia.

 

Satish holds a Ph.D. and MS in Chemical Engineering from Kansas State University and a B.Tech. in Chemical Engineering from the Indian Institute of Technology, New Delhi, India. He has published more than 70 scientific publications on various topics related to the field and is also an Adjunct Professor in the Department of Physical Pharmaceutical Chemistry, BMC, Uppsala University, Sweden.

 

 

  Dr. Franziska Riesen, Head Drug Product Manufacturing
     
   

Franziska Riesen brings to Lonza more than 14 years of experience in sterile and aseptic drug product manufacturing and Quality Assurance. Before her current role at Lonza, Franziska worked at Roche in various functions, with responsibilities that included managing the manufacturing of liquid products in vials and pre-filled syringes, and leading cross-functional contract manufacturing teams.  She also represented the company during inspections and audits, including U.S. Food and Drug Administration (FDA), Japan, and Swiss Authorities.

 

Prior to her experience in manufacturing, she was responsible for Quality Assurance activities for drug product manufacture and Quality Control, including release, stability, transfers, discrepancy management, corrective and preventive actions (CAPA), change control, and complaint management.