Sartorius Stedim India PAT Forum

Event date: 
Mon, 2017-06-19 to Fri, 2017-06-23
Location: 
India

Biopharmaceutical manufacturing is characterized by validated process steps and extensive lab testing procedures. The FDA PAT-Guidance recommends the potential use of PAT tools for improving development, manufacturing, and quality assurance through innovation in product and process development, process analysis and process control.

PAT is a risk-based strategy for designing, analyzing and controlling manufacturing processes. The Critical Process Parameters (CPPs) are identified in line with the definition of the Critical Quality Attributes (CQAs) of intermediates or final products. PAT offers a number of tools for measuring and controlling these CPPs.

Join us at any of the below listed locations and gain more insight into synchronized solutions from Sartorius based on analytical systems, process software and control tools.

Presentations:

Complete Upstream Solutions with BioPAT® tools | BioPAT® MFCS 4: The New Standard in Bioprocess Management

Presented by | Dr. Henry Weichert
Field Marketing Manager – PAT & Automation | Europe & Asia Sartorius Stedim Biotech, Germany

Quality by Design (QbD) principles and application of Process Analytical Technology (PAT) are showing significant cost and risk mitigation benefits in biopharmaceutical process development and production. However cell cultivation, currently still lacks reliable online analytics, data management and integrated automation technologies, which hamper the successful implementation of the QbD/PAT concept. Moreover, this point is clearer when considering the trend and uptake of single-use/disposable bioprocessing solutions.

For using the advantages of the QbD approach it is crucial having a centralized SCADA hub. This should working as a tool for data acquisition, data storage, automated process control via recipes and connection to the chemometric tool box. Sartorius has a well-established solution with the MFCS/win 3.0 with over 3000 installations. This system fulfills the requirement of R&D labs as well as the GMP manufacturing. The new version MFCS 4 follows in direct line this approach.

In this presentation Sartorius platform on integrated data acquisition, data management and advanced control via different PAT solutions will be demonstrated as basis for application of QbD principles.

Multivariate Data Analysis in PAT Applications

Presented by | Sabyasachi Goswami
Asia Sales Manager – Umetrics Data Analytics Sartorius Stedim Singapore

This presentation will introduce you to Design of Experiment (DOE), Multivariate Data Analysis (MVDA) and how these wonderful technologies are used by Pharma and Biopharma manufacturing companies to design, measure, understand and control the process. It will also motivate the audience to use “easy-to-use” tools to visualize vast amount of multivariate data and take appropriate decision in real or near real time. From Descriptive and Diagnostic analytics to Predictive and Prescriptive analytics!

Exhibition

We invite you to meet our subject matter experts and discuss advanced upstream and PAT solutions for efficient bioprocess development and robust manufacturing, as well as to benefit from our product display.

Networking Dinner | Hyderabad, Ahmedabad

Sartorius Stedim India will be hosting a dinner post the forum of presentations and discussions.

Networking Lunch | Pune, Bangalore

Sartorius Stedim India will be hosting a lunch post the forum of presentations and discussions.

Who should attend

 
This seminar has been designed for individuals from process development, R&D, manufacturing and quality assurance working with collection and interpretation of experimental raw data to achieve optimized processes. 
 
 
You will discover:
  • Insights into PAT solutions from Process Development to Commercial Manufacturing
  • Opportunity to network and exchange ideas with subject matter experts and industry peers

Registration

To register**, either

Reply to: news-india@sartorius-stedim.com

or

Call the below listed contact

Rupa B
Phone: +91 80 4357 3212

Please RSVP before Monday June 12, 2017 to reserve your seat.

**Kindly mention the location you wish to attend.