Tuesday, September 17, 2013

#BPIConf 2013: A Look at Manufacturing Strategy

Conference chair Ran Zheng, Executive Director, Plant Manager, Amgen Inc. kicked off the morning with sharing that in 2012, there were 38 US FDA approvals, 50% were biologics.  We must pursue facility changes and fundamental capabilities to enable the production. She encouraged companies to embrace the culture of innovation and anticipate changes in market.

In our next presentation, Chris M. Brodeur, Associate Director, Commercial Operations, BioMarin
presented Implementing and Improving Disposable Systems in BioMarin’s Manufacturing Environment to Meet Growing Capacity.  When creating and updating their facilities, they have design for flexibility, minimize filling impact to approved products, allow for future process introductions and use disposables to enhance flexibility and efficiently. Brodeur states that they’ve added disposables wherever possible in their production plant. He encourages attendees that when they consider building a facility, they should start with the end in mind. He also cautioned that when creating a facility with disposables, much of facilities are no longer hidden in the walls, but all out in the open.

Our next presentation was Maximizing Efficiencies and Capacity Utilization in a Multi-Product Clinical and Commercial Facility from John Kenneally, Director, Drug Substance Manufacturing, Genentech, Inc.  He starts out with question: Flexibility versus Throughput: Do you really have to choose between the two? Both can be accomplished with speed but a company  has to consider their priorities.  For example: is it more important to get 3% more out of process or get there six months earlier?

Our next speaker Naveen Pathak, Associate Director, Technical Strategy, Manufacturing Science & Technology, Genzyme, a Sanofi Company presented A Case Study in Creation of a Strategic Technical Lifecycle Plan (TLCP) for Continuous Improvement of a Legacy Biological Process.  It is important to enable infrastructure to chart the TLCP Course. In this example, a governance model was created to dictate the flow of communications between teams. You need to have good technical solutions. This is the pathway to achieving a successful plan. All solutions should be strategic, sound and right sized. For every project, it was evaluated through a grid that looked at regulator/quality/compliance, Process understanding, product supply and business efficiency. After you have programs and have grouped them, you now have to create the plan. Resources and timeline knowledge are needed to create the model. It should look forward to the future state and will help you figure out the model you can use to get this TLCP completed. Both projects and programs can overlap. There should be touch points that can be checked to make sure that all programs work across processes.  Naveen also participated in a podcast we recorded for BioProcess International Magazine.  Listen to it and other presentations from this year's speakers here.

In the presentation from Jolene Ignowski, Staff Development Scientist, Bayer Healthcare,emphasized that in the right situation, perfusion must be done continuously. They must move the product from the bioreactor. Efficiencies in the process to develop this product that must be considered: process design, equipment, people. To increase process design, they eliminated unite operations and took advantage of new technologies. They use disposables for quicker turnaround time. They also use interchangeable disposables to save time that comes with disposables. Perfusion is not an efficient manufacturing method, but unstable products need them. By improving manufacturing processes and standardizing the flow and staff to make this happen difficult process happen.

In our final session of the morning, Sourav Kundu, Ph.D. Director, Biopharmaceutical Development, Teva Biopharmaceutical USA looked at the Biosimilars Development Pathway and began with a basic question - Why biosimilars? Worldwide the population is growing and aging. There are more chronic diseases along with an increase in the number of patients. The emerging markets are also expanding and looking into innovative products. Populations are demanding good quality healthcare. On the supply side – companies and governments – are mandated to control costs. For manufacturers, they’re seeing an increasing cost to manufacture these drugs. The annual growth rate for biologics has been 20% and isn’t showing signs of slowing. Almost all biologics are being worked on, looking for biosimilars or biobetters. Recent approvals have taken place. Biosimilars present a front-loaded effort. The amount of work upfront is massive – create a reference product database, reacting the molecule, in-depth characterization of assay development then follows a path of clinical studies eventually followed by a launch.

A critical decision point for any molecule is deciding if the product a biosimilar. Other considerations include: are there any product differences? Decision points are if the product is safe and effective. Maintaining biosimilarity is a challenge. It must be done and maintained through the process development, scale up and manufacturing. Change of scale can complicate biosimilarity.

Stay tuned for updates this afternoon focusing more on manufacturing strategy and highlights from our keynote speakers including James Thomas of Amgen, Sandra Poole of Genzyme and Dr. Abbie Celniker of Eleven Biotherapeutics.

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