From bench to bedside: Stacy Springs and the BioMAN program connect theoretical concepts to real world application

In 1978, there were just 30 patents granted for biopharmaceuticals. Now biologic drugs make up more than 28% of all pharmaceutical sales - $41.7 billion in 2013. MIT CBI’s BioMAN program is focused on translating all of the research into successful manufacturing, so theoretical concepts can be turned into real world applications. They do this by bringing together thought leaders from across the biopharmaceutical industry including manufacturers, vendors, the FDA and academia. They also leverage the MIT research they have access to in order to advance new technologies as well as assess the global landscape.

This year MIT put out a report called “Convergence: The Future of Health” which states: “Convergence comes as a result of the sharing of methods and ideas by chemists, physicists, computer scientists, engineers, mathematicians, and life scientists across multiple fields and industries…it needs to be applied to help solve many of the world’s grand challenges.” To that we can add - as scientific discoveries progress collaboration between the academic world, the government and manufacturers is key to solving these challenges. That is what BioMAN was set up to do.

We at Biotech Week Boston have asked writer Nick Paul Taylor (Nature, Fierce Biotech, Regulatory Focus) to report on several innovators who are contributing to this convergence of disciplines and institutional boundaries here in Boston, and Nick reports on the work Stacy Springs  is doing at BioMAN Institute. At BioMAN Stacy is the Director of the Biomanufacturing Program and Executive Director of the Consortium on Adventitious Agent Contamination in Biomanufacturing. We’re proud to feature her in our report “Convergence in Boston: How multidisciplinary R&D is driving bench-to-bedside breakthroughs”. BioMAN “fosters a collaborative research environment that brings together thought leaders from industry, the government/FDA and academia.” Click to download and read about Stacy Springs and MIT’s CBI BioMAN program (no email address or registration is required).

We hope you enjoy Nick’s in-depth report. You can catch up with Stacy Spring’s newest research at Biotech Week Boston's Bioprocess International Conference and Exhibition event this October. Stacy will be on a panel entitled "Industry-Academia Collaboration in Translational Research and Biomanufacturing of Next Generation Biologics".

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Design of Experiments for Fed-Batch Process Development in Shaken Cultures

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Design of Experiments for Fed-Batch Process Development in Shaken Cultures.

Design of Experiments for Fed-Batch Process Development in Shaken Cultures

When designing a recombinant protein production process, a high number of parallel cultivations must be carried out. That task is typically performed using batch cultures in shake flasks or microwell plates, in which fermentation conditions are not monitored. To overcome that limitation, we combined the SensorDish Reader and Shake Flask Reader systems (from PreSens) with an enzymatic glucose delivery system (EnBase technology from BioSilta Oy) for Escherichia coli cultivations. Our objective was to determine whether SensorDish reader cultures would yield reproducible process data that were directly comparable to those at shake flask scale (left).

 Especially in the biopharmaceutical industry, a consistent process development from microliter to industrial scale requires consideration of many different perspectives to completely understand a transition process. We created a design of experiments (DoE) to determine optimal parameters at two different cultivation scales. Such batch-type cultivation principles in orbitally shaken systems (mostly shake flasks, but also microwell plates and bench-scale fermentors) are used to obtain acceptable results with as little effort as possible. Unfortunately, they are mostly carried out without considering the important influence of conditions in large-scale production on product quality and process yield. To learn more, read the article here.


You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.

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Accounting for the Donnan Effect in Diafiltration Optimization for High-Concentration UFDF Applications

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies.

Accounting for the Donnan Effect in Diafiltration Optimization for High-Concentration UFDF Applications

The biopharmaceutical industry is targeting high-concentration protein formulations to enable subcutaneous administrations. Such administration can provide better patient convenience than intravenous administration. One challenge associated with high-concentration formulations is increased electrostatic interaction between proteins and excipients. That is a result of increased protein-charge density at high protein concentrations. Such interactions can create an offset between excipient levels in final products and diafiltration buffers in ultrafiltration processes. The effect of such electrostatic interactions in a membrane process is known as the
Donnan effect.

The Donnan effect on excipient levels has received significant attention in recent years. Theoretical modeling has been developed to predict excipient and pH changes as a result of the Donnan effect in monoclonal antibody (MAb) processes. One model based on the Poisson–Boltzmann equation provided good prediction of excipient levels in the final retentate pool. A second model developed by Bolton et al. demonstrated to be predictive for basic MAb and acidic Fc-fusion proteins. The latter study also included several mitigation strategies to achieve target levels of excipients at the end of an ultrafiltration–diafiltration (UFDF) process. Both publications provide tools for understanding the influence of the Donnan effect on target formulation excipients. By contrast, our study focuses on the influence of the Donnan effect on removal of starting buffer excipients during diafiltration.

Read the full article here.


You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.

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Process Improvements Increase Production Capacity of a Legacy Product

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Process Improvements Increase Production Capacity of a Legacy Product.

Process Improvements Increase Production Capacity of a Legacy Product

Implementation of postlicensure process improvements in the biopharmaceutical industry can benefit patients and drug manufacturers alike. Here we demonstrate through a case study how a change to the cell culture medium and process can be taken from proof of concept through scale-up to demonstration of feasibility. We further illustrate the scope and complexity of implementing a change in commercial manufacturing to realize significant benefits such as increased production capacity over an existing legacy process.

The Importance of Postapproval Improvements
Drug development is a complex process, and related business drivers typically shift through a drug’s life cycle. Before market licensure, the emphasis is on ensuring product safety and efficacy during clinical trials in addition to speed to market (left). The need to lock a process in as soon as possible limits opportunities for optimization. As a consequence, process optimization and capacity improvements are often postlaunch activities performed when the scope of market demand and the competitive business environment are both better understood. After a product is launched, related business drivers shift toward cost of goods (CoGs) and ensuring supply to patients while maintaining product quality. After launch and throughout a commercial production life cycle, process optimization is performed within the strict regulatory and quality frameworks of biopharmaceutical products, of course.

Read the full article here.



You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.

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