BioPharma Asia

17/09/2022

BOOK YOUR FREE SEAT FOR THIS WEBINAR

CHALLENGES IN THERAPEUTIC BIOLOGICAL PRODUCTS
Single use systems and process aids play a key role in the manufacturing process of biopharmaceutical products. These components are often used in critical part of the process and consistent performance and quality level is required to meet the expectations of regulatory agencies and end-users. Change and variability in the design, manufacturing or final treatment may result in a modification of the functional and quality profile of the material and it can influence the quality attributes of the drug substance and the drug products. In this webinar, we will review the strategies to monitor and control variability in process materials and assess the impact on biopharmaceutical products.
Presented Paolo Grisostomi, Senior Engineer, Materials Science at Biogen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific and Dr. Sona Kovackova, Study Director Small Volume Parenteral applications, Nelson Labs



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Presented by Paolo Grisostomi, Senior Engineer, Materials Science at Biogen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific

17/09/2022

The Exogenously Driven Disruption of Bioprocessing

Presented by Christos Varsakelis, Team Lead Artificial Intelligence/Machine Learning at The Janssen Pharmaceutical Companies of Johnson & Johnson and Pranjul Mishra, PhD ,t eam lead of application science at Yokogawa Insilico Biotechnology GmbH

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Industry 4.0 comes with an impressive collection of assets and capabilities. However, although the degree of applicability in Bioprocessing is high, the origin of these technological innovations is exogenous. This is not without implications and in this talk we are concerned with their identificatio...

17/09/2022

Book your free seat for this webinar on The Path to Smart Manufacturing and Intelligent Development within Industry 4.0 – Building an Integrated Sensing Strategy on September 20th at 10am EST/ 3pm BST and 4pm CEST

Over the years there have been many frames of reference on the use of process analytical technology (PAT) in the commercial manufacturing space including monitoring, closed loop control, quality control/real time release, advanced process control, quality by design, Industry 4.0, etc. With each evolution of framing, the context we view process sensing and analysis of manufacturing processes is trending towards expanded scope and context from unit operation to production train, plant level, and up through manufacturing network, supply chain and value chain to customer. Similarly in the Development space, the frame of reference on the use of PAT continues to evolve as various capabilities become standard aspects of pharmaceutical and biopharmaceutical process technology stacks enabling the use of digital twins, modeling, and workflow automation which aim to drive more efficient and reliable development, technical transfer, and lifecycle management practices. In this talk we will present how we at Biogen are integrating PAT as part of our Digital Evolution strategy on a pathway towards realization of Smart Manufacturing and Intelligent Development.
Presented Dan Hill, Associate Director, Digital Development & Analytics, Product & Technology Development at Biogen and Chris McCready, Lead Data Scientist at Sartorius Stedim Biotech and Martin Gadsby Vice President at Optimal Industrial Technologies Ltd.
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Path to Smart Manufacturing and Intelligent Development within Industry 4.0 - Building an Integrated Sensing Strategy Over the years there have been many frames of reference on the use of process analytical technology (PAT) in the commercial manufacturing space including monitoring, closed loop cont...

19/08/2022

BIOPHARMACEUTICAL PROCESS DEVELOPMENT – TRENDS/ CHALLENGES/OPPORTUNITIES

Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Previously Principal Scientist, SLS – Global Regulatory and Validation Consulting group at Pall - Biotech & Sr. Manager - Pharma and Regulatory consultant, India & SEA at Pall Corporation

This webinar discusses three things:

1) Current trends and regulations affecting Biopharmaceutical Industry

2) The journey from Lab scale to Commercial –Overcoming Scalability design hurdles

3) QbD-Bringing Improvements in Biologic development and Manufacturing Space.

Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and Validation ...

05/08/2022

UST IN TIME RELEASE OF CAR T CELL THERAPIES

Presented Irving Ford Head of CAR T QC Laboratories at Celgene now VP, Head of Quality at Adaptimmune, followed by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux

The views and opinions expressed during the Webinar are those of the presenter.

Currently, CAR T products typically represent the final treatment option for patients suffering from various forms of cancer. It is critical that CAR T products are manufactured and returned to the patient in an expedited manner. As such manufacturers of CAR T products must adopt and utilize Quality Risk Management (QRM) principles during manufacture, testing, and release.

Risk-based contamination control strategies must be employed from apheresis collection through final product release. A risk assessment, encompassing each step of the manufacturing process, should be performed to highlight potential areas of microbial ingress. Where possible, mitigating actions must be implemented to eliminate the risk or to reduce the risk to an acceptable risk level.

Based on a well-defined and documented microbial contamination control strategy, it should be possible for manufacturers to implement a just-in-time microbiological release strategy. This Webinar will highlight microbial contamination control and testing strategies that can be employed throughout each stage of the manufacturing process that will allow for the potential just-in-time release of CAR T products.

JUST IN TIME RELEASE OF CAR T CELL THERAPIESPresented Irving Ford Head of CAR T QC Laboratories at Celgene now VP, Head of Quality at Adaptimmune, followed...

05/08/2022

BIOPHARMACEUTICAL PROCESS MODEL EVOLUTION – ENABLING PROCESS KNOWLEDGE & ADVANCED PROCESS CONTROL

Presented by Saly Romero-Torres, Ph.D. Romero-Torres, PhD, previously Senior Manager, Advanced Data Analytics, Biogen now Quality Maturity Strategy Lead at Thermo Fisher Scientific, followed by David Lovett, Managing Director at Perceptive Engineering & John Mack, Engineering Director at Perceptive Engineering now Head of Product Unit at Applied Materials

Biogen is adopting modelling maturity models similar to the ones used by high-tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial, particularly when implementing data-driven models that rely on process experience. A well-planned modelling continuum should allow the pharmaceutical industry to realize the benefits of modelling activities early on while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).





https://youtu.be/kT03RcvQxvk

23/07/2022

Presented by Dr. Dr. Bernard McGarvey, PhD Chemical Engineering

Within the pharmaceutical industry, creating a robust Operational Control Strategy (OCS) is a key step to accomplishing the goals of Quality by Design (QbD). Along the way to developing this robust Operational Control Strategy, many problems will be encountered that need to be solved. The use of a First Principles-based approach provides value because it improves the effectiveness and efficiency of our problem solving, thereby leading to solutions that are more likely to work without unintended consequences and were created in a faster and more cost-effective manner. Based on the author’s experience, a clear definition of what First Principles are will be given (and what they are not!). Areas of opportunity where the application of First Principles is likely to be successful will be described. An outline of a high-level process for implementing a First Principles-based approach will be presented. Finally, an example of the application of the First Principles in the pharmaceutical industry will be briefly
described.

Presented by Bernard McGarvey, PhD Chemical EngineeringWithin the pharmaceutical industry, creating a robust Operational Control Strategy (OCS) is a key step...

15/07/2022

CASE STUDY & EXPERIENCE ON SANOFI’S & SGS’S IMPLEMENTATION OF BPOG’S LEACHABLE RISK ASSESSMENT MODEL

Presented by Ken Wong, Critical Material Management Lead at Sanofi Pasteur

A brief review of the BPOG’s Leachable Risk Ranking model. A case study of the leachable risk model implementation in Sanofi will be presented. All changes to specific risk factors and weight changes will be discussed. Finally, the lesson learns and experiences of the risk model performances on several projects will be shared.

Dujuan Lu, Manager/Global Lead of &L at SGS

Extractables and leachables (E&L) from the plastic process materials used during pharmaceutical and biopharmaceutical manufacturing can potentially pose risks to the safety, efficacy, and stability of pharmaceutical and biopharmaceutical products. The USP risk assessment model will be briefly reviewed. Challenges regarding the design of extractions and analytical evaluation threshold (AET) calculation for process materials will be discussed. A few case studies regarding the E&L studies of process materials will be shared.

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Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGSBrief review of the BPOG’s Leachable Risk Ranking mo...

08/07/2022

THE JOURNEY TO LEAN IMPLEMENTATION FOR EFFICIENCY INCREASE

Presented by Uwe Voelker, Previously Site Head, Sterile Drug Product Manufacturing at Roche & now Senior Executive in Quality and Technical Operations, a.o. Roche.

This webinar discusses:

1) Adoption of strategic and systematic use of lean principles to improve
2) operational efficiencies and cost competitiveness
3) Systematic reduction of waste, complexity and variability,
4) Reduction of order lead time,
5) Higher employee satisfaction and engagement in tackling the cultural challenges
6) Achieving speed and reliability in the manufacturing value chain.

Presented by Uwe Voelker, Previously Site Head, Sterile Drug Product Manufacturing at Roche & now Senior Executive in Quality and Technical Operations, a.o. ...