New Drug Product Development Using Continuous Manufacturing


28th May 2019 | 9:00 GMT, 10:00 CET and 13:30 IST | Giustino Di Pretoro, Associate Director Drug Product Development an Johnson and Johnson And Dr. Robin Meier, Manager Scientific Operations at L.B. Bohle Maschinen |BOOK FREE SEAT

– What is Drug Product Continuous Manufacturing?
– Is Continuous Manufacturing really worth the effort? “without data, you are just another person with an opinion”
– What are the challenges implementing CM?
– Development and tech transfer considerations for CM.

Learning Objectives:

  • Demonstrate finacial and operational benefits of Continuous Manufacturing
  • Explain the key challenges in the implementation of CM in R&D
  • Explore key strategies in drug product development of CM

 

Presented by Giustino Di Pretoro, Associate Director Drug Product Development an Johnson and Johnson

Giustino Di Pretoro is an Associate Director at Janssen Pharmaceutica, a Johnson & Johnson Company. Dr. Di Pretoro is a subject matter expert and drug product development lead for continuous manufacturing, and coordinator for a series of academic collaborations within the field. Before joining Johnson & Johnson, Giustino was Team Leader and Principal Scientist at Novo Nordisk AS (DK), where he was heading a formulation team focusing on oral delivery of biomolecules, and prior as R&D and Business Development Manager for a Swiss CMO, focussing on novel technologies for particle size reduction and solubility improvement of class II BCS drugs. Giustino holds a Ph.D. in Pharmaceutical Technology and Msc. in Industrial Pharmacy, from the University of Milan (I). Within his Ph.D. he worked as Research Scientist at the University of Cambridge (UK) in the Chemical Engineering and Biotechnology department, and later as visiting postdoc in Pharmaceutical Technology at the University of Düsseldorf (DE).

Sponsored by L.B. Bohle Maschinen+ Verfahren GmbH

L.B. Bohle Maschinen + Verfahren GmbH is a global acting manufacturer for the pharmaceutical industry. The range of products includes process and handling equipment for the pharmaceutical solids production.

The company was founded in 1981. A large number of well-known multi nationals belong to the group of satisfied Bohle customers.

Bohle has got an export rate of about 80 %. Nearly 30 % of the total turnover is generated in the US.

Besides the batch processing technology L.B. Bohle focusses on continuous processing with the continuous production unit QbCon®.

The headquarters are in Ennigerloh, Germany, with an operating area of 40,000 m2. About 250 specialists build a highly qualified team.

Furthermore, the company is represented worlwide in about 40 countries by independent sales agencies.

The Technology Center at the headquarters was inaugurated in 2015. Bohle created the continuous production unit QbCon® together with a consortium from industry and academia. The unique feature of QbCon® is that the tablet production can be implemented either without granulation, with dry or wet granulation, in one system.

The modular concept of continuous production offers substantial time savings since it does not require any time-consuming analyses of the product samples between the process steps.

And Dr. Robin Meier, Manager Scientific Operations at L.B. Bohle Maschinen + Verfahren GmbH

Dr. Robin Meier is Manager Scientific Operations at L.B. Bohle Maschinen + Verfahren GmbH and in his function responsible for the Technology Center, the QbCon®-line at L.B. Bohle and all scientific collaborations with universities and within scientific consortia. Robin is a pharmacist by education and received his doctorate in pharmaceutical technology and biopharmacy with his work on the continuous production of tablets based on twin-screw granulation. He is leading an experienced team of process- and automation engineers, who are focusing on the continuous improvement and development of the existing batch machines and the continuous manufacturing equipment.


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