Continuous Manufacturing Processes for Biotechnological Products - US edition

31 May-1 June, 2023

The environment for recombinant proteins used as biotherapeutics is changing.

Continuous Manufacturing Processes for Biotechnological Products - US edition

In the context of developing new biological entities, the bioindustry should further improve speed to clinic, gain in manufacturing flexibility while reducing costs of good sales (COGS).

 

31 May-1 June, 2023, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

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Pharma Online Masterclass

Overview

 

The environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities, the bioindustry should further improve speed to clinic, gain in manufacturing flexibility while reducing costs of good sales (COGS).

Despite at start of the recombinant era in the 80s/90s, continuous upstream processes have been applied especially for sensitive molecules such as hormones, cytokines and blood factors, the development of monoclonal antibodies as drugs was mainly based on large-scale fed-batch upstream connected to chromatography-based purification operated in batch. However, since the last ten years, it seems that the productivity of manufacturing processes of recombinant proteins based on large-scale fed-batch and classical chromatography processes has reached a plateau. As new technologies in cell separation and automatization of chromatography-based processes emerged, continuous manufacturing becomes a valid option for improving manufacturing productivity, flexibility and COGS.

Whereas continuous manufacturing is now well considered for small molecules, it is not yet the case for biologics. Despite, some challenges still exist in applying continuous manufacturing processing for biologics, that approach could address some of the current limitations of large-scale fed-batch processes.

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Who should attend?


Big, media and small size pharma companies, medical device companies, biopharma companies from all around the United States.

 

• Process development scientists and managers

• CMC development program managers

• Manufacturing managers

• QC and stability control managers

• Heads of Quality Assurance

• Drug Regulatory Affairs managers

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Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany