Bioproduction Group completes independent Market Research Study

Bio-G recently commissioned a study by the market research firm, King Research, a firm specializing in qualitative and quantitative research for technology corporations.

Goals

The goal of the study was to learn what challenges are faced by customers and prospective customers in biotechnology manufacturing. We also wanted to understand what products and services customers would like to see to address their biomanufacturing challenges. We also wanted to learn what customers recommend with regard to marketing and other outreach efforts for Bio-G in future.

Methodology

The research methodology consisted of two key components. First, a survey was sent to subscribers to BioProcess International, resulting in 57 completed surveys. Then, in-depth interviews lasting 50 - 60 minutes each were also conducted with 23 customers responsible for engineering, manufacturing process design, operational excellence, project management, supply chain development and management. This total of 80 substantial inputs from customers gave us a comprehensive view of customer perceptions and needs.

Results

Nearly 70% of survey respondents are not using biotechnology manufacturing process modeling software today. The majority of interviewees told us they were familiar with simulation and process modeling software but felt it was designed for other industries and still had significant gaps in meeting their biotech-specific needs.

The most frequently mentioned manufacturing/business challenges faced today are interrelated and include, coping with the complexity of the manufacturing process, the avalanche of supply chain and production data, the consolidation of facilities resulting in more products being manufactured in a single facility, the cost of inefficiencies and bottlenecks, and ramping production to the maximum level possible in a single facility (debottlenecking)

Aside from customers who are using Bio-G products and services, most of the interviewees rely heavily on their experienced staff and a mix of basic tools, e.g. Excel, plus techniques that don’t really get close to addressing the supply chain and production challenges they face and which are described above.

Our interviewees described severe limitations of the tools and techniques they use today. They described a long list of features of their “ideal” solution, most of which tightly matches what Bio-G provides today. Interviewees described a long list of expected positive outcomes as a result of implementing their “ideal”.

Actions Resulting from This Research

Based on what customers recommended in this research study, Bio-G now has a significant to-do list with regard to outreach efforts. We’ve participated in conferences for quite a while and that will continue. In addition, we’re significantly updating our website, starting a newsletter and writing white papers on topics that customers described as significant challenges.

We received very helpful feedback on what customers want in their “ideal” solution, and this will be used to drive product development. We’ll also start a Customer Advisory Board (CAB) to help drive product development priorities in future.

While this survey and interview project has given the company excellent guidance on customer perceptions and needs, we plan to continue listening to customers via future surveys, interviews, CABs and onsite customer meetings.

Bioproduction Group announces results of National Science Foundation Research

Bioproduction Group has announced significant technical results in their research collaboration with the National Science Foundation (NSF). The goal of the project was to establish a new technology for high-speed simulation that could be used to model risk across the entire biopharmaceutical manufacturing network.

Results to date indicate that Bio-G has achieved simulation speeds orders of magnitude higher than conventional simulations, at considerably greater detail. "The technology allows us to model entire biopharmaceutical supply chains to a stunning degree of accuracy", comments Bio-G Principal Rick Johnston. "This means a better assessment of risk, and significant direct savings for biopharmaceutical manufacturers". The technology has already been deployed in several multinational biotech manufacturing networks, where it has shown millions of dollars in direct cost savings.

Planning in biopharmaceutical manufacturing has long been hindered by low-resolution, average-case models that fail to model variability and risk. Such toolsets may plan well for "the average day" but cannot provide the kinds of service guarantees biotech companies need to promise to their patents. It is hoped the new technology will break such a paradigm, allowing biomanufacturers to truly understand the very real risks in the manufacturing suites.

The technology also has the ability to be used to model low probability, high impact events - such as Genzyme's contamination issues in 2010, which cost that company more than $175 million in fines due to contamination. Modeling of such rare but important events has traditionally been hindered by a lack of understanding of the effects of those events, and simplistic models which failed to understand their true impact. Bio-G's new modeling technologies for the first time allow biopharmaceutical companies to truly understand such risks, and produce comprehensive plans that address them.

Bioproduction Group featured on cover of Innovations in Pharmaceutical Technology journal

Bioproduction Group appeared in the March 2010 issue of Innovations in Pharmaceutical Technology. The issue opened with a special focus on biomanufacturing, where Bio-G's use of simulation tools in the optimization of biopharmaceutical manufacturing processes were examined.

The article, entitled 'Simulation Tools in the Optimization of Biopharmaceutical Manufacturing Processes' was a review of the use of simulation technology in the manufacturing industry and its increasing usage across all sectors of biomanufacturing. The article specifically reviewed the use of simulation for scheduling and planning, process optimization and debottlenecking, and late-stage process development work.

The full contents of the article are available online at: http://www.iptonline.com/.
(Click the 'IPT e-book' option on the right, to see the article.)

Bio-G presents Flexible Facilities analysis at the 2009 Biomanufacturing Development Summit

Bioproduction Group presented analysis at the Biomanufacturing Development (BMD) Summit this year in San Francisco, CA. The research aimed to quantify how to value 'flexibility' in a biopharmaceutical manufacturing facility.

Bio-G's research was based on the wild fluctuations in demand and excess capacity over the last 10 years, from an extreme capacity shortage in the early 2000's to the current glut of capacity in large biotechs in 2009.

Bio-G presented data showing that the clinical trials create a vast range of possible final demands, where success or failure in each phase of trials either creates a blockbuster or a relative flop. This coupled with the long lead times to build new facilities mean that biotech manufacturers must build significant excess capacity to deal with the very highest demand scenario - no matter how unlikely that might be.

Bio-G built on Kaminsky's and Johnson's findings in 2007 (Click here to view) that a flexible facility in this environment is actually one that can be quickly built and licensed - in as short as 2 years rather than the current 5-7 year timeline. Such a flexible facility, if built, is 22% less likely to be significantly over-sized, and 14% less likely to be significantly smaller than the capacity needed. These risks translate into tens of millions of dollars in potential savings for the average biotech manufacturer, and hundreds of millions of dollars for large manufacturers.

Bioproduction Group works to link Process Development and Operations models at 2010 Biomanufacturing Summit

Bioproduction Group (Bio-G) presented a case study with a major biopharmaceutical manufacturer linking together models from both late stage Process Development and Operations Groups. A new hybrid "Simulation Facility Fit" model was developed and tested that aimed to speed technology transfer and increase model accuracy by 95%. This model was designed to accurately show the run rate of a new product or process of significantly different titer, placed in an existing (retrofitted) facility.

The project arose out of Bio-G data indicating existing process models account for only 60% of the actual activity times in the facility. Bio-G worked with a major manufacturer who had an existing chemical and mass-balance model that performed filter and column sizing, flow-through rates and other key process parameters. Using operational data from this facility and a Bio-G simulation model, the Bio-G team overlayed the facility simulation on the existing process model. The result was a 'one click' solution where Process Development staff could change titers or other settings and see the results in terms of runs per week, utilization of key equipment, and kilograms of product produced.

"The critical element of this model is the ability to accurately estimate plant throughput for a process never before seen in the plant", comments Principal David Zhang. The analysis showed that traditional facility fit models produce results that are far more optimistic than the facility's capability (130-160%) while the simulation model produced results within 5% of the actual run rate.

Bio-G presents Flexible Facilities analysis at the 2009 Biomanufacturing Development Summit

Bioproduction Group presented analysis at the Biomanufacturing Development (BMD) Summit this year in San Francisco, CA. The research aimed to quantify how to value 'flexibility' in a biopharmaceutical manufacturing facility.

Bio-G's research was based on the wild fluctuations in demand and excess capacity over the last 10 years, from an extreme capacity shortage in the early 2000's to the current glut of capacity in large biotechs in 2009.

Bio-G presented data showing that the clinical trials create a vast range of possible final demands, where success or failure in each phase of trials either creates a blockbuster or a relative flop. This coupled with the long lead times to build new facilities mean that biotech manufacturers must build significant excess capacity to deal with the very highest demand scenario - no matter how unlikely that might be.

Bio-G built on Kaminsky's and Johnson's findings in 2007 (Click here to view) that a flexible facility in this environment is actually one that can be quickly built and licensed - in as short as 2 years rather than the current 5-7 year timeline. Such a flexible facility, if built, is 22% less likely to be significantly over-sized, and 14% less likely to be significantly smaller than the capacity needed. These risks translate into tens of millions of dollars in potential savings for the average biotech manufacturer, and hundreds of millions of dollars for large manufacturers.

Bio-G presents Facility Fit model at Bioprocess International Conference

Bioproduction Group's new Facility Fit technology was presented by Rick Johnston at an invited address for this year's Bioprocess International (BPI) Conference in Raleigh, Durham. BPI is the largest conference for biopharmaceutical operations in the industry. His presentation showed how Bio-G's advanced simulation platform can be used to provide highly accurate performance estimates of new products and process platforms in existing plants.

Fitting new processes or products into existing plants has traditionally been evaluated using chemical mass-balance models. However these process models are often poor estimators of actual process performance, since they fail to account for operational issues in the plant. Bio-G's research has shown that only around 50% of the overall processing time and 20% of the variability in the process are explained by these models.

Bio-G's Facility Fit model for the first time integrates operational plant data into late-stage process design. This allows a much more accurate view of process fit, speeding technology transfer as well as accurately estimating key parameters like run rate. The technology is currently being deployed in a number of large biopharmaceutical manufacturers.

For more information, check out our case study: Building a Next Generation Facility Fit Tool

Bio-G's High-Speed Network Engine awarded National Science Foundation SBIR grant

Bioproduction Group has been awarded a grant from the National Science Foundation (NSF) to further develop their cutting edge technology for simulating biotech supply chain networks. Bio-G's research in this area has already demonstrated millions of dollars in savings for biopharmaceutical companies, through inventory and risk reduction.

In the proposal review, NSF Reviewers applauded Bio-G's innovative toolset and highlighted its benefit to biotech manufacturers. In their response, they commented:

"Large scale simulation modeling as presented in this proposal would be a tremendous strategic tool for a manufacturing firm.
If this could be effectively implemented it would create competitive advantage for any firm that utilized it."

Bio-G's Network Simulator is a next-generation tool for modeling complex biotech processes that enables both very accurate simulation models, and a broad network view of facilities and inventory flows. It does this by utilizing Bio-G's next generation simulation toolset that runs hundreds or thousands of times faster than existing simulation toolsets.

NSF Reviewers also recognized the broader impact of such a network tool for the wider manufacturing industry:

"Application of this innovative facility and linked network simulation technology could have an enormous impact on inventory costs for the global industry."

Bio-G research presented in Biopharm International's August 2009 edition

Bio-G research was presented in the prestigious Biopharm International Journal. The August 2009 article, entitled 'Garbage In, Garbage Out: The Case for More Accurate Process Modeling in Manufacturing Economics' was a case study revealing the importance of accurate process modeling in Biopharmaceutical Operations.
Click here to read the paper.

Bio-G presents Operational Excellence analysis at Europe's Bioinnovation Leaders Summit

Bio-G's advanced decision-making toolset was presented at the Bioinnovation Leaders Summit in London, England. Bio-G's advanced toolsets for Operational Excellence, were presented showing case studies identifying key areas for performance improvement. Bio-G's toolset drew considerable interest from the crowd, especially in the ability to give quantitative analysis of bottlenecks and target-set areas of improvement.

Cutting edge Bio-G research presented at Winter Simulation conference in Miami

Bio-G's advanced research was presented at the simulation industry's most prestigious conference in Miami. The paper examined methods for establishing the credibility of sophisticated simulation models, focusing on empirical methods for experimental design. Case studies were presented based on work done with biopharmaceutical manufacturing industry partners.
Click here to read the paper.

Bio-G's tools showcased at Biopharmaceutical Manufacturing and Development Summit in Raleigh, Durham

Bioproduction Group software and solutions were showcased this year at the Biopharmaceutical Manufacturing and Development summit in Raleigh, Durham. The approach generated considerable excitement, as a growing number of Biopharmaceutical firms explore the importance of detailed modeling approaches such as simulation for maximizing their capacity and understanding of key process parameters.

Bio-G research presented at prestigious Bioprocess International Conference

Bioproduction Group simulation data was presented by Bio-G in two tracks at the leading industry conference on Biopharmaceutical Operations, the BPI conference in Anaheim, Los Angeles, CA. The talks focused on empirical evidence of variability and risk in the biotech supply chain, and simulation models to mitigate that risk.

The first talk focused on Process Economics models under the presence of variability. Bio-G discussed firstly how this task is becoming increasingly difficult with more complex processes and high levels of variability in Operations. Simulation modeling was proposed as an approach to provide more accurate costing estimates, with several case studies presented.

The second talk by Bio-G looked at a maturing industry facing cost pressures with an increased need for analysis of manufacturing and logistics, an approach that has greatly benefited other high-technology industries. Bio-G showed how advanced simulation models could provide detailed results with a high degree of process accuracy.