Name: Extractables and leachables testing using a Quality Risk Management approach
Start: 2018-10-17T14:00:00Z
End: 2018-10-17T15:18:50.000Z
Location: BrightTALK

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Leachable risk management continues to be of regulatory interest. However we continue to rely on experimental extractable studies as predictors of leachable risk. These are complex to design and implement, and do not always offer the answer to what is the leachable risk for a drug product or medical device. We hope to show that mass transport modelling provide an alternative or a complementary element to testing the leachable risk. There are relatively simple mathematical models which can be developed which might provide an estimate of maximum leaching in a system. These can estimate factors such as solubility, partitioning and diffusion if successfully constructed and in combination these can estimate leaching. There are several ways which these might be modelled and this presentation will discuss each one. The presentation will illustrate where modelling might replace or support current approaches which rely upon experimental study. Results from modelling is complementary to risk appraisal, as predictive modelling gives quick insight into effects of storage time, temperature and other kinetics of leaching. This could be used to screening different materials and predict their leaching characteristics perhaps more effectively and efficiently than current extractable test protocols leading to better leachables studies to confirm these models.

Mass Transport Modelling in support of leachable risk management.

Full title: The Importance of Accurate Chemical Characterization of Medical Devices Extractables

The Importance of Accurate Chemical Characterization of Medical Devices...

Full title: Utilizing Cell Culture Platform and High-Throughput Bioreactors to Streamline Upstream Process Development and manufacturing scale up 

Discuss how to accelerate the clone selection with using the bioreactor systems
Understand how to implement the bioreactor systems e­ffectively with a minimal resources    
Know how to scale-down model definitions suitable for design space, QbD, or other BLA-enabling activities.

Utilizing Cell Culture Platform and High-Throughput Bioreactors to Streamline...

Full Title: Commercial Cell Therapy Experience Using Mycoplasma NAT For Product Release: Five-Year Review

Commercial Cell Therapy Experience Using Mycoplasma NAT For Product Release...

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals

Safety Evaluation on Extractables and Leachable

UNICAN: Dual capability in single use bioreactors

Disposable technology is being used more each year in the biotechnology industry. Disposable bioreactors allow one to avoid expenses associated with cleaning, assembly and operations, as well as equipment validation. However, one of the biggest challenges for single use technology including single use bioreactor is single sourcing of consumables. Typically, the consumables are tied to the hardware eliminating the flexibility and interchangeability among existing systems, which ultimately forces the end user to rely on a single vendor’s supply chain. In order to address to this challenge, a 200L bottom mounted single-use bioreactor was converted into a universal can, or “Unican”, which supports the use of both bottom mounted agitator and top mounted agitator single use bioreactors. The implementation of Unican increases flexibility for cell culture operations, improves assurance of supply, allows handling of any bag film changes/issues in future and reduces the dependence on single suppliers. As part of the project, mass transfer and cell culture experiments were performed to ensure optimal performance of both bags in the Unican. Cell Culture data and mass transfer was shown to be comparable in both top and bottom mounted bags with historical data. Additionally, the modification of system was performed such that no hardware requalification was required post modification. The system has been successfully implemented in pilot plant for bioprocessing.

UNICAN: Dual capability in single use bioreactors

Downstream protein purification and product concentration is known to be the most challenging part of the process development. It is also known that the Downstream process development is critical to ensure protein drug’s quality, safety & efficacy meet regulatory expectations. When initiating the development, the Chemistry, manufacturing and controls considerations for process development and manufacturing must include molecule complexity. Raw materials, process development. Equipment and manufacturing, Quality and Regulatory affairs. The critical factors for development and manufacturing is performing stage-wise assessment on Product development, analytical and process development and not the least, the manufacturability assessment. The expected qualities of a superlative process shall include increased capacity, flexibility, cost-effectiveness, controllability, scalability, and efficiency. However, general challenges exist in downstream process development involving,

Balancing higher cost chromatography resins and solvents
Constrained purification space for molecules prone to degradation at wide range of pH and temperature
Process fit to multi-product facility,
PAT availability to accelerated processing
Adaptation of new technologies one of smarter way to address the challenges:
Non-Protein A process
use of next-generation chromatography resins
Continuous processing for capture, intermediate purification, Viral clearance

Best Practices of Downstream Protein Purification and Product Concentration

Full Title: Annex 1 and Environmental Monitoring Program - Implementation And Justification of The Best Practices In Routine

What is new? How to implement the changes?
EM program and Contamination Control Strategy
Example of Risk Analysis Methodology
EM program and Data Management
 

Presented by Benoit Ramond, Head of Microbiology & Sterile Technology at Sanofi

Benoît Ramond is a Doctor in Pharmacy at the University of Paris XI in France and obtains a PhD in Microbiology. He has more than 30 years of experiences in the Pharmaceutical Industry. Since 2016 he is Head of Microbiology and Sterile Technology Expertise in Sanofi Group including Aseptic Processing, Barrier Technologies, Environmental Monitoring Program, Cleaning and Disinfection, Visual Inspection.  In his function he has also a leading role in the Annex 1 implementation program within Sanofi.

Annex 1 and Environmental Monitoring Program - Implementation And Justification.

Digitally Transforming Pharmaceutical Process Development and Manufacturing: Enabling Technologies for a Sustainable Future

The focus on accelerated development of new modalities for advanced therapies and challenges with complex drug candidates has driven adoption of novel concepts and technologies in pharmaceutical development and manufacturing. The active substances have become more structurally complex and R&D timelines continue to be compressed, the technologies necessary to provide safe, robust and economical access to these molecules needs to keep pace. Enabling technologies such as automation and associated information management systems are increasingly being used in the development and manufacturing of therapeutics across the pharmaceutical industry to collect, analyze, and interpret an immense amount of advantageous process data that would otherwise be inaccessible. This combination provides many additional benefits, such as enabling processes, ability to safely handle highly reactive, unstable, and toxic reagents. All these aspects help to minimize the time and cost associated with development and manufacture of drugs and bring medicines to patients more effectively. The importance of such concepts has become even more evident in recent Covid-19 pandemic crisis, different organizations are actively thinking of implementing these paradigms to their benefit. In order to fully leverage and integrate the larger organization, end-to-end automation and information management strategy and vision is necessary where there is seamless workflow for automated route screening to optimization and scale-up of robust process is established. This presentation will share AbbVie’s strategy and experiences in integrating such end-to-end technologies into process development and manufacturing facilities and discuss the challenges and opportunities associated with our approaches.

Digitally Transforming Pharmaceutical Process Development and Manufacturing

Presented by Dr. Markus Zeitz, Head of Global Quality Digital Transformation at Boehringer Ingleheim

Quality Analytics –How to Leverage Quality Data for QMS 2.0

Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale for DS Manufacturing

The presentation outlines a case-study in establishing the operational space of a Grignard reaction in a series of continuous stirred tank reactors (CSTRs). The development of a laboratory scale continuous flow process for the manufacture of a key intermediate of the pharmaceutical product Ipatasertib for the treatment of metastatic castration-resistant prostate cancer and triple negative metastatic breast cancer involves flow and batch unit operations. In a head-to-head comparison between the continuous and batch processes, the former was clearly superior as it gave a higher yield (81% vs 63%) of the product and better reaction control for handling the unstable reaction intermediates. Short residence times, accurate temperature and pH control and steady concentration profiles enabled the synthesis of product in excellent and invariable purity The gathered data and experiences from this study was crucial for guiding the decision making process in order to design a suitable pilot setup for the subsequent cGMP campaign.

Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale...

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 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.

Path to Smart Manufacturing and Intelligent Development within Industry 4.0

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 identification and quantification. We commence with the onboarding of an exogenous technology problem. Industry 4.0 tools have been developed with different objectives in mind. Integrating them in Bioprocessing requires a critical a priori analysis of similarities and transferability.  We then move on to address a fundamental question: is this exogeneity positive or negative for Bioprocessing?  The answer is drawn from historical case studies, stemming from different industries. This naturally leads us to the concept of  the fallacy of division and the associated dangers of disruption. Finally, we go a step further and explore how the addition of 4.0 in Bioprocessing can alter the core business activities and what this implies for the insourcing vs outsourcing dilemma that both big and small corporations have to face.

The exogenously driven disruption of Bioprocessing

Full title: ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics.

ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables...

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

Challenges In Therapeutic Biological Products

An overview of single use manufacturing for the production of AAV gene therapy products with comparisons to traditional monoclonal antibody production.  Specific challenges of scaling up AAV production and considerations to accommodate a range of demands of differing gene therapy products will be discussed.  I will review the reasons for starting and the challenges of being the inhouse manufacturing facility for a rapidly growing company.  The challenges of making non-COVID products in the era of Warp Speed along with future commercial production comparing fully single use with a hybrid facility will be explored.

Single Use Process for Production of AAV Gene Therapy Products

Manufacturing processes for gene therapy products are generally low yielding compared to production processes for other biologics. The material requirements to support analytical, comparability, and stability activities at all stages of development could exceed the requirements for clinical dosing. This talk will highlight some of the key material requirements at different stages of development and discuss options for maximizing use of available material.

Clare Blue holds a degree and PhD in Molecular Microbiology from the University of Glasgow, Scotland, UK. She has industry experience ranging from viral / vector manufacturing, biosafety testing, analytical development, QC and process development. Clare has been involved in AAV gene therapy for over 7 years, initially at Nightstar Therapeutics where she held senior roles overseeing the manufacturing and analytical strategy of phase II/III AAV products for treating retinal diseases.  In her current role as Director of Analytical Development, Biogen, she is involved in all aspects of clinical AAV product development. Clare is also an advocate for sustainable development.

Material Requirements to Support Gene Therapy Development

The Use of Stability Modelling to Support Accelerated Vaccine Development & Supply 

Stability assessment is particularly relevant for vaccines, due to the typical need for cold storage to remain stable. When stability evaluation is exclusively based on real-time data, it may represent a bottleneck for rapid and effective vaccine access. Stability modeling for vaccines represents a key resource to predict stability based on accelerated stability studies. This Webinar session reports a cross-company perspective on stability modeling for vaccines, demonstrating  that modeling approaches can be highly valuable to predict vaccines’ shelf life and behavior during shipment or manipulation. Also, it is demonstrated that modeling methodologies need to be tailored to the nature of the vaccine, the available prior knowledge, and the monitored attributes.  

Presented by Didier Clenet, Research Scientist Formulation & Stability chez Sanofi Pasteur, Jos Weusten, Senior Statistician and Applied Mathematician at MSD (Oss, The Netherlands), Marilena Paludi, Lead Statistician presso GSK, and Cristiana Campa, Technical R&D Advisor at GSK

The Use of Stability Modelling to Support Accelerated Vaccine Development...

• Understanding extractables and leachables for better adoption of single use systems
• Ensuring safety of drug through determining the level of leachables throughout product life cycle
• Case Study of implementation of standardized testing protocol

Extractables and leachables testing using a Quality Risk Management approach

Biopharma

Extractables

Leachables

Quality Risk Management

Bioprocessing

Biologics

Biotechnology

Pfizer

Biosimilars

Biopharmaceuticals

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Extractables and leachables testing using a Quality Risk Management approach

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