BioCast™ Webinars

Please select a BioCast below to download. (Free, Registration Required.)

→ Facility Fit for Biopharmaceutical Production

In this webinar, we will examine our Bio-Fit application, a comprehensive toolset designed to allow these two groups to collaborate together to fit a process to a target facility. Bio-Fit is a simple-to-use Excel template with no ongoing license fees and an 'open access' model that allows you to add your own calculations and VBA code. It can be used on its own, or integrated with a server system to store and collaborate on models and connect to manufacturing and other databases. The toolset has been developed over the past decade in close partnership with biomanufacturers and is designed to be flexible in meeting the needs of most types of mAb / E-Coli / Viral as well as fed-batch and perfusion-based platforms.

→ Risk Mitigation Strategies to prevent Drug Shortages

In this webinar, we examine a data driven approach to risk mitigation that integrates both supply based capacity assessments, and demand-based assessments of risk. Manufacturers are increasingly realizing that effective risk mitigation strategies cannot be done 'on the back of an envelope'. We'll see how Bio-G's suite of toolsets is instrumental in helping manufacturers build quantitative understanding of risk, and providing actionable data to build different kinds of buffers in their manufacturing and supply chain systems.

→ Portfolio Forecasting in the Life Sciences Industry

In this joint IMS Consulting Group and Bio-G webinar we'll look at how to address these issues with CrossLink, a comprehensive forecasting platform designed specifically for the Life Sciences industry. The system integrates horizontally across a portfolio and vertically between managers and forecast developers. We'll explain how CrossLink's Excel-based modeling workspace can be custom-configured to fit the needs of a diverse portfolio while maintaining rigorous forecasting standards and the ability for apples-to-apples comparisons across brands. We'll also show how CrossLink's enterprise-class software empowers management to access forecast information in real-time, compare programs, and conduct what-if analyses.

→ Increasing the Flexibility of Biomanufacturing Facilities

In this webinar we'll describe how Bio-G's Real-Time Modeling System allows manufacturers a practical toolset to maximize the flexibility and run-rate of their facilities while avoiding miscalculations and costly retrofits. We'll demonstrate an end-to-end approach for Facility Fit, commercial scale up and run-rate optimization in a multi-product environment. Bio-G has more than a decade of experience in managing new product introduction at some of the largest facilities in the world. Join us to see some of the critical considerations in this area.

→ Real-Time Scheduling of Clinical Biomanufacturing Facilities

Clinical / Pilot biomanufacturing facilities are difficult to effectively schedule for two reasons. First, each campaign is different and may involve different resources or fermentors - unlike a commercial facility, where each batch is identical. Second, clinical facilities are required to respond to frequent changes to the schedule to accommodate research and development needs. These two issues result in scheduling that is often highly manual and sub-optimal facility utilization. In this webinar we'll describe how Bio-G's Real-Time Scheduling software allows clinical biomanufacturing facilities to respond in seconds to changes in requests, or based on conditions on the floor. Such an approach avoids 'locking down' the schedule weeks in advance and maximizes the flexibility and responsiveness of these critically important biomanufacturing facilities. We'll also demonstrate how the completed schedules can be communicated to manufacturing staff in real-time, on their smart phones and calendars.

→ The Impact of Variability in Biopharmaceutical Manufacturing

In this webinar, we examine the impact of variability in biopharmaceutical manufacturing. Using real data, we suggest that variability is the single biggest issue facing biopharmaceutical manufacturers today, affecting not only unit operations but the entire supply chain design and management. The presence of significant variability requires systems that can 'sense and respond' in real-time, so that issues can be resolved quickly and before they impact product quality.

→ Capacity and Productivity in Biopharmaceutical Production

This webinar focuses on key results from the 9th annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. The report surveys 302 individuals at biotherapeutic developers and CMOs in 29 countries worldwide, plus 186 industry vendors to determine key industry trends. The report is unquestionably the most comprehensive in the industry and shows year-by-year snapshots of changing perspectives around capacity in the last decade at the world's leading biomanufacturers. The report is available at: http://www.bioplanassociates.com/publications/bmcp.htm

→ Joint Emerson and Bio-G Webinar

In this joint Emerson / Bio-G webinar, we examine the mining of electronic data from Emerson's Syncade™ Suite Operations Management software, visualizing and analyzing it in real-time. We'll show how the Bio-G Crosswalk™ software allows this validated data source to display real-time batch data and associated parameters. The close integration of these toolsets allows biomanufacturers to increase the value of automation systems, and reduce the maintenance burden associated with extracting and manipulating raw data.

→ Managing High Titers in Biopharmaceutical Manufacturing

In this webinar we'll outline a number of approaches to understanding and managing increased titers in commercial biopharmaceutical production. We'll explore the impact of titer on downstream chromatography steps, buffer preparation and hold steps and practical techniques that can be used to alleviate bottlenecks. We'll also show how companies can understand the impact of titer on their facility in terms of run rate and long-term planning.

→ Identifying and Mitigating Risk in Biopharmaceutical Supply Chains

In this 60 minute webinar and Q & A session, our two panelists, Professor Phil Kaminsky from the University of California at Berkeley and Rick Johnston, Ph.D. from Bio-G will present their perspectives on supply chain risks and supply chain risk mitigation in our industry.

→ Capacity Planning in Biomanufacturing: Effectively Managing Uncertainty

In this webinar we'll outline a number of approaches to understanding and managing the uncertainty associated with capacity planning. We'll explore how to evaluate the capacity of existing and new biomanufacturing facilities at a range of titers and volume ranges. We'll also show how to plan for a portfolio of new indications, identifying potential outliers ('black swans') that must be specially accounted for.

→ SAP and the Bio-G Real-Time Modeling System

SAP is used extensively in the biomanufacturing industry, and now this important, real-time data can be integrated with other data sources, visualized and analyzed using the Bio-G real-time modeling system. Because the Bio-G real-time modeling system is "aware" of all the steps in the manufacturing process, variability, resources and their complex interdependencies, this SAP data can now become a key part of optimizing the biomanufacturing system.

→ Quality by Design -- An Industry Perspective

In this webinar and Q & A session, our two panelists, Jim Lambert from Genentech and Rick Johnston, Ph.D. from Bio-G present their perspectives on Quality by Design (QbD), and then answer questions about the implementation of QbD in biopharmaceutical manufacturing. We discuss the linkage between QbD, Quality Risk Management, and Risk Effectiveness Monitoring. We outline the importance and value of implementing QbD and continuous verification-style methodologies, and describe how to successfully implement such methodologies.

→ Optimizing Biomanufacturing using Design of Experiments

Today's biomanufacturing facilities are complex and exhibit high variability in unit operation times. This makes debottlenecking and other process optimizations extremely difficult and time consuming. In this webinar we show how today's leading biomanufacturing facilities use large scale Design of Experiments, or DOE, to optimize their facilities. We describe why such an approach is necessary, how DOE can help solve the problems facing today's manufacturing facilities, and the practical effect of running DOEs.

→ An Introduction to Bio-G

Bio-G builds software that allows the world's leading biotechs to consolidate, visualize and analyze real-time data, resulting in the optimization of biomanufacturing processes. In this short webinar (30 minutes), we introduce our company and describe the spectrum of what we do, why it is important to our customers around the world, and how our unified solution is becoming the biomanufacturing industry standard.

→ Biomanufacturing Operational Excellence

Operational Excellence is focused on delivering higher quality product at a lower cost. Such groups have been very successful in other industries but are being challenged in biotech where regulation discourages process change. Managers also want to know: how can Operational Excellence deliver improvements when we've already focused our best people and tools at achieving such goals? Is there really room for additional optimization, when we're "doing the best we can" today? In this webinar we will describe an approach which has allowed Operational Excellence groups to deliver millions of dollars in savings by changing the way their organizations understand and analyze processes.

→ QbD and Me: How to implement ICH Q10 in biotech

How do Quality by Design principles actually get implemented on the manufacturing floor? In this webinar, we show how to take QbD off the 'drawing board' and actually implement these ideas that make a measurable difference to biomanufacturing quality. We focus on specific tools, including: - Statistical process and quality control measurements (SPC and SQC) - 'Golden batches' for continuous time measurements like pH in a bioreactor - Correlating process parameters with quality outcomes and how this can drill down on 'critical' vs non-critical measurements - Multi-unit operation correlation to show how a process variation impacts processes and quality downstream

→ Modeling and Simulation in Biopharmaceutical Production

In this inaugural 60 minute webinar and round-table discussion, Professor Lee Schruben will answer questions about the use of modeling and simulation in biopharmaceutical manufacturing, and supply chains. This webinar will focus on how companies can successfully implement modeling technologies to deliver real value in their organizations, as well as an overview of how design-of-experiment, scheduling and the role of data affect modeling approaches.

→ Real-Time optimization of biomanufacturing facilities and networks

Debottlenecking and process optimization are currently time consuming, difficult processes costing thousands of dollars and often falling short of delivering the improvements they promise. In this webinar we explore the three main causes for these challenges in biotech: old data, process variability and complex resource interdependencies.

→ Real-time Scheduling of Biomanufacturing Operations

In this webinar, we show how Bio-G's toolsets enable biomanufacturers to see data and publish schedules, in real time. This allows users to see schedules for themselves, their functional group, or the facility as a whole in Outlook, Google, and a host of other email applications.

→ Real-Time Scheduling of Biomanufacturing Supply Chains

Biomanufacturing Supply Chains are unique in their need to account for variability and risk in bulk, fill and packaging production and inventory positioning. We'll describe a different approach to biomanufacturing supply chain planning that optimizes inventory levels and risk strategies in real time.

→ Achieving Quality by Design through Statistical Process Control

Quality by Design (QbD) is a catch-phrase in the biotech industry but few facilities implement true QbD in their day-to-day operations. In this webinar, we will look at how Crosswalk allows enterprises to use Statistical Process Control (SPC) - common in other industries - to achieve continuous QbD. We look at specific examples from data sources in the enterprise and how these can help achieve higher service levels and lower failure rates.

→ Biomanufacturing Capacity: A Complete Systems Approach to Optimizing Production

Biomanufacturing facilities are complex and the current imperative is to do more, with less. A glut of capacity, new products, and substantially higher titers are forcing a re-evaluation of how to understand and optimize productive capacity. In this webinar, we will show how modeling toolsets can be used to drive a deeper understanding and optimization of the biomanufacturing process.