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The BioProcessing Summit

Tuesday Jul 21, 2015

BPTC Senior Consultants, Drs. Sheila G. Magil and Frank Riske, will be leading CHI’s Introduction to Bioprocessing training seminar during its annual BioProcessing Summit  held from August 3-7, 2015 in Boston, MA. The 1.5 day seminar, held on August 3-4, offers a comprehensive survey of the steps needed to product today’s complex biopharmaceuticals, from early development through commercial manufacturing. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follows. They then step through the stages of bioprocessing, beginning with the development of cell lines and ending at scaling up for commercial production. They will also explore emerging process technologies, facility design considerations, and the regulatory and quality standards that govern our industry throughout development. The important roles of analytical methods at all stages of development as well as formulation and stability assessments in developing and gaining approval for a biopharmaceutical are also examined. This class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing, or support functions who would benefit from a detailed overview of this field.

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How To Take Charge of Your COGS

Monday Jul 13, 2015

By Rick Stock  (rstockatbptcdotcom)  

In my last blog, I wrote about all the gory details describing expenses that can go into cost of goods sold (COGS) for biopharmaceuticals. However, I did not describe why COGS are so important to model in the first place. The simple answer is that a good model allows you to forecast COGS based on information from development runs at scales that are very different from the intended commercial scale. For drug substance, this may be in the form of cost per gram. For drug products, this is often in the form cost per dose, whether this be a vial, pre-filled syringe or other delivery device.

Routinely the most important COGS related calculation is the cost per dose. A good model will calculate accurate costs that are a critical factor in determining whether your product will be economically viable at the anticipated selling price. Of course, the selling price is generally determined by what the market can support. For many products, there is also a trade-off between price and sales volume; as prices are lowered, sales volume increases. Similarly, there is a relationship between production volume and COGS, which can be forecast with a good model. Having an accurate COGS model as early as possible in the development process is extremely useful to assist companies in determining appropriate investment, sales and marketing strategies that will guide future product development activities. Just take a look at these top ten disastrous launches. In many of these cases, failure to set a reasonable market price and manage COGS contributed to the unsuccessful product launches.

A current area that is hot for applying COGS modeling is biosimilars. Many of the blockbuster biologics have or will soon experience patent expirations. This will introduce competition into the market for many biopharmaceuticals, causing many big pharma companies to take a hard look at reducing price to ensure market share with potential biosimilar competition. Historical data from these well-known processes are useful in constructing a very accurate cost model, which can aid in developing strategies for innovator product firms. On the other end of this spectrum are the biosimilar companies. These companies are applying COGS modeling very early in the development stages to determine which target molecules are worth manufacturing for the biosimilars market and to establish COGS targets for these products.

Finally, COGS models can aid in determining the costly portions of the manufacturing process for all companies manufacturing biologics. Results from these models drive manufactures to remove “economic bottlenecks” by heading back to process development to increase titers and purification yields, reducing labor with new technology or outsourcing activities in order to reduce COGS. A COGS model developed early in the product life cycle will allow you to identify the key cost drivers in your manufacturing process at all stages of development. This approach will provide the insight required to inform critical manufacturing decisions that significantly impact the success of your product(s).

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Big, bigger, but will they be the biggest? The past, present and future of MAbs in the market place

Monday Jun 15, 2015

By Dawn M. Ecker  (deckeratbptcdotcom)  

The modern biotechnology era began in 1982 with the approval of Humulin in 1982[a], the first recombinant product. Throughout its 32 years of existence, the biopharma industry has grown tremendously, launching over 200 biopharmaceuticals. As indicated in Figure 1, the 182 currently marketed products have generated an unprecedented $152B in global sales[b] in 2014. When the current number of pipeline products in development are coupled with discoveries and technological advances in the biopharmaceutical sciences, product revenues for the biopharmaceutical industry can only continue to grow.

For a third consecutive year, Humira is the world’s best-selling biologic and for the last two years, sales of Humira have exceeded $10B. The first biologic to break the $10B barrier in 2013, Humira sold $12.5B in 2014, recording the highest sales for a recombinant product since the beginning of the modern biotechnology era. Table 1 displays the remaining top ten biopharmaceuticals of 2014, which include a cytokine, two insulins and seven antibody-based products. The antibody product Lucentis, which has made its initial debut in the top ten in 2014, has the distinction of being the first commercialized antibody fragment product produced using a microbial system.

Looking back a decade to 2004, when biopharma was in its twenties – total sales for the then 88 approved products didn’t quite reach $50B. The top ten selling biopharmaceuticals back then were slightly more diverse, with four hormones, three antibody products, two cytokines and an insulin. Interestingly, in both 2004 and 2014, the top ten selling products comprised nearly half of all biopharmaceutical sales and four of the top ten products in 2004 have remained on the top ten list for 2014: Enbrel, Remicade, Rituxan/Mabthera, and Neulasta/Neupogen. Gone from the 2004 top ten list are the four epoetin-based hormones, the human insulin and the cytokine, replaced with insulin analogs, and more antibody products.

Ten years ago, monoclonal antibodies were beginning to make their presence known, and now, MAbs are a formidable portion of today’s biopharma landscape. Surveying the overall recombinant biopharmaceutical pipeline, it is clear from our bioTRAK® database, that antibody products dominate the development pipeline. Of the nearly 400 products in late stage development (Phase 2 through BLA/MAA/NDA application), over 80% are antibody related products. Looking closer at the antibody products and fragments in development, nearly 10% of these antibody products are produced in microbial systems. With several companies developing single chain, domain fragments and some full-length antibodies in non-mammalian systems, potential exists in the next decade for the additional commercialization of these microbial-based antibody products.

Slide1

 

 

Slide2As the development and commercialization of antibody products continue to forge ahead with no slowdown in sight, we can be assured antibodies will remain the cornerstone of the biopharmaceutical market for the foreseeable future. When looking forward to 2025, does the past decade suggest that Enbrel, Remicade, Rituxan/Mabthera, and Neulasta/Neupogen will continue to be amongst the top 10? Will microbial manufactured antibodies and fragments be “the next big thing”? Only time will tell, but we can’t wait to see.


[a]http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm081964.htm#ftn10back

[b] http://www.bptc.com/pipeline-databases.php

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Contracting – how to make it a win-win

Friday Jun 12, 2015

By Al Doig  (adoigatbptcdotcom)   and Patti Seymour  (pseymouratbptcdotcom)  

Global prescription spending exceeded $1 trillion in 2014 and revenues from biopharmaceuticals accounted for nearly 15% of this spending. Almost a third of all drug products in development are biopharmaceuticals that will contribute to the total pharmaceutical spend going forward. This anticipated biopharmaceutical sector growth will have a significant impact on future pharmaceutical company revenue. An increase in biopharmaceutical development will also drive growth for contract manufacturing services. On June 17 at BIO 2015 in Philadelphia, Patti Seymour, Senior Consultant at BioProcess Technology Consultants, will lead a panel discussion in the BioProcess Theater on “Managing the Contract Relationship”. Joining Ms. Seymour in this discussion will be Stephen Taylor, SVP, Commercial at FujiFilm Biotechnologies; Justin Skoble, Senior Director, Technical Operations at Aduro Biotech, Inc.; Tom Douville, Director, Biopharmaceutical Development at Kolltan Pharmaceuticals, Inc.; and Lily Vakili, Senior Counsel at Faber Daeufer & Itrato PC.

This panel will explore the selection and contracting process for developing and manufacturing biopharmaceuticals beginning with a detailed request for proposal (RFP). Preparing an RFP helps the client think through its needs and allows the CMO to provide an appropriate proposal, which can then form a basis for CMO evaluation and negotiation. A step-by-step negotiation process might begin with a letter of intent leading to a master services agreement that represents the appropriate interests of both parties. Contracts for biopharmaceutical develop and manufacturing services require both sides to consider a number of critical issues including risk management, intellectual property ownership, dispute resolution, cost control, access to data and information and timely performance.

The panel, representing the client and contractor perspectives, will use results from BPTC’s most recent bioPULSE® survey, Key Considerations for Selecting an Outsourcing Partner, and contract negotiation case studies to illustrate approaches and outcomes to achieve mutual agreement regarding risk, failed batches, timelines, costs and data/information access, etc. This shift toward collaborative working relationships is good business for the CMOs. Clients benefit by in getting their biopharmaceutical into the clinic. Next week’s panel is sure to provide insight into the issues facing clients and CMOs. Visit us at booth #3230 after the panel to continue the conversation.

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Can we have it all? The quest for quality, cost and speed in Biopharma

Wednesday Jun 10, 2015

By Al Doig  (adoigatbptcdotcom)   and Tom Ransohoff  (transohoffatbptcdotcom)  

At BIO next week in Philadelphia a panel of experienced biotech executives will tackle this question. There are important drivers in our industry for improving cost, quality, and speed. Until now, conventional wisdom said you could choose two of the three. Today, we are asked to deliver on all three areas simultaneously with no likely trump card in the deck. The need for speed is the upshot of breakthrough therapies, the boom in biosimilar interest and new discovery opportunities. The focus on Quality by Design (QbD) requires a deeper understanding of our processes then ever before. Finally, competition from biosimilars and healthcare cost controls are forcing us to focus on reducing our cost of goods sold (COGS) and development costs.

The panel at BIO will explore the options and opportunities likely to assist in meeting the challenges. Operational excellence initiatives and related efforts, such as advancements in platform processes, can help improve performance, but truly novel approaches and the introduction of new technologies will be critical to meaningful progress. The implementation of new technologies, such as continuous processing, process analytical technologies, and novel facilities concepts will be a focus for the discussion. Novel approaches to critical operational areas such as supply-chain management will also be party of the discussion.

The panel chaired by Tom Ransohoff, BPTC and four other biopharma veterans: Joanne Beck, Shire; Parish Galliher, GE Healthcare; Lynne Frick, Pall and Mark Brower, Merck, will convene in the BPI Theater at BIO (Booth #3207 in the BioProcess Zone) at 12:00PM on Tuesday, June 16, 2015 (not Thursday, June 18 as previously indicated and published in the May issue of BPI). This discussion, of course, takes place within an industrial context in which innovation or even incremental change is a high-risk game. Sign up for our RSS feed to follow this discussion in a follow-on blog from BPTC summarizing the panel’s thoughts and suggestions and if you’ll be in Philly don’t forget to visit BPTC at booth #3230 to share your experiences. We look forward to lots of comments and discussion.

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