How are biopharmaceutical manufacturers managing the variability within their supplier base?

This week, we turn our sights to look at raw materials and supply chain management at Biopharmaceutical Development and Production Week.  Speaker David Kolwyk, M.S., MBA, Principle Scientist, Material Science, Amgen Inc. recently sat down to join us for an interview and previewed many of the topics he plans on look at during his presentation Strategies for Managing Impurities in Upstream Raw Materials.

Today, he shares what he sees as some of the major trends in raw material management strategy from a technical perspective?

I think that there is a variety of ways that they’re doing that. I think what suppliers are doing right now, one of the things suppliers and manufacturers are collaborating on to work together on this is both exchange of data. In the past maybe you just received a certificate of analysis for your final product. Now some suppliers and some customers are exchanging more data. Maybe a certificate of manufacture with a list of the raw materials, maybe it’s a C of A for all the raw materials that were used in the cell culture media. So, they need more visibility to the components – the suppliers of those components – into the manufacturing process.

I think another thing, as well, I think end users and biopharmaceutical manufacturers are doing more work upon incoming receipts. So, they are applying new technologies, such as raman spectroscopy to create a spectral reading, which creates a richer data set on those individual raw materials that are brought in. And then what they can do is employ tools, such as multivarient analysis to be able to detect weak signals from those richer data sets. And that starts to be able to point directionally as to whether or not there are differences lot-to-lot that are impacting the manufacturing process.

I think by combining both some of these analytical tools, such as Ramen and some of the statistical analysis tools, such as multi-varient analysis and then also the increased collaboration with our suppliers and being able to get data set and more visibility to specific places. We are starting now to be able to map out and better understand exactly how components within a complex raw material, such as cell culture media, can impact the process performance in our manufacturing environment.

David will be presenting Strategies for Managing Impurities in Upstream Raw Materials on Wednesday, March 26 in San Diego.  For more information on her session and the rest or the program, download the agenda.  If you'd like to join us for Biopharmaceutical Development and Production Week, as a reader of this blog, when you register to join us and mention code BDP14BLOG, you can save 20% off the standard rate.

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Biopharmaceutical Development and Production Event: Spotlight on Methods & Molecules

In 2013, the Biopharmaceutical Development and Production Event will continue the tradition of bring you more programming and networking opportunities while helping you address new methods for the development, production and regulatory challenges you face. This year we are pleased to announce, BDP Week programming to whole new level, focusing on two brand new areas: methods and molecules. Today, we highlight the new focus areas of our event: Methods and Molecules.

The first two days of the event will look specifically at methods. We will share strategies and technologies which can be applied to specific processes and product quality operations to overcome challenges to help you:

• • Implement Process Validation and Continuous Verification in the New Paradigm
• • Leverage Contract Manufacturing and Technology Transfer for Improved Bioproduction
• • Prepare to Meet Future Demands for Analytical Technologies
• • Control Raw Material Variability and Improve Supply Chain Transparency
• • Mitigate Contamination Risk with Viral Safety Strategies to Meet Regulatory Standards

The final three days, we’ll switch gears and look at molecules. Technical innovations, process improvements and designing new processes (upstream and downstream), manufacturing strategies and novel approaches for developing many different types of molecules throughout the product lifecycle. Including these focus areas:

• • Improve Existing and Design New Upstream Processes for Today and Tomorrow
• • Enter the New Age of Biopharma with Next Generation Downstream Processes
• • Develop Biosimilars that Meet Speed, Cost-Efficiency and Similarity Challenges
• • Implement Facility of the Future with Manufacturing Strategies and Lifecycle Management
• • Streamline the Path from Development to Commercial Success for Antibody Drug Conjugates
• • Transform Bispecific Antibody Design, Development and Production

For more information on the Methods portion of the program, download the agenda.

Biopharmaceutical Development & Production Week will take place February 25-March 1, 2013 in Huntington Beach, California. If you’d like to join us, register today with priority code BDPW13BLOG and save $200 off the standard rate.

If you have any questions about the program, feel free to contact Jennifer Pereira.

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Biosimilars: The complex process to determine safety and efficacy

To bring a biomilar to market is difficult.  One of the most challenging parts of the process is copying the original innovator product.  Dove Press published a paper that takes an in-depth looking to this process.

Here's an excerpt on the looking at that topic:

Various complexities associated with approval of a biosimilar include: i) evidence of integrity and consistency of the manufacturing process, ii) conformance of manufacturing standards to applicable regulations, iii) demonstration of product consistency with appropriate innovator product or comparators using assays that should be relevant and most of all standardized, so that several biosimilars of the same biologic can be comparable, including comparative pharmacokinetic and pharmacodynamic data and the extent of clinical data, and iv) experience with the approved product. ⁽¹²⁾   Further, issues like post-translation modification and immunogenicity are the key concern related to approval of biosimilar products.13 Scientists are of the opinion that the use of biosimilars is an opportunity for us to use cutting-edge technology to solve health problems and guide clinical processes.

12. Covic A, Cannata-Andia J, Cancarini G, et al. Biosimilars and biopharmaceuticals: what the nephrologists need to know – a position paper by the ERA-EDTA Council. Nephrol Dial Transplant. 2008;23: 3731–3737.


Read the full white paper here.

This year,the Biopharmaceutical Production and Development Week will address Biosimilar Development and Production in detail focusing on the develop biosimilars for the global market through critical understanding of market dynamics and regulatory challenges, precise analytical characterization and innovative production.  For more information on this portion of the program, download the agenda.  If you'd like to join us in register by December 14 and mention BDPW13BLOG to save $300 off the standard price! 

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