BioProcess Blog

BioProcess Blog |

Subscribe to our RSS Feed

The BIO International Convention

Thursday May 14, 2015

Join BPTC at the annual BIO International Convention in historic Philadelphia, PA from June 15-18, 2015 to exchange ideas and insights on biotech’s most relevant and timely topics with the industry’s thought-leaders. We encourage you stop by booth #3230 to meet with our subject matter experts and explore how we can support the technical, strategic, and regulatory aspects of your biopharmaceutical development programs.  Can’t wait until June? Email us  (jadamatbptcdotcom)   to discuss your immediate needs now!

Share

World Biosimilar Congress USA 2015

Monday Apr 27, 2015

Join BPTC at Terrapinn’s World Biosimilar Congress from May 27-28 in sunny San Diego, CA to discuss how to tackle common barriers to accessing the US biosimilars market such as high development costs, time-consuming R&D, lengthy clinical trials. This conference brings together 4 complementary events, including the World Biosimilar Congress, Americas Antibody Congress, Cell Culture World Congress, and Downstream Processing World Congress. Stay ahead of the innovation in this evolving industry by visiting us at booth #12 to learn more about our technical, strategic, and regulatory consulting services!

 

Share

Can You Afford Not to Embrace Innovation?

Thursday Apr 23, 2015

By: Patti Seymour  (pseymouratbptcdotcom)  

IBC’s Biopharmaceutical Development and Production Week, usually held somewhere in southern California in late March to attract the winter weary from the east coast and mid-west, was, as usual, a very informative event. There were several presentations/sessions that focused on innovation in bioprocessing. My colleague, Tom Ransohoff, discusses the innovations for continuous processing in an earlier blog. I found a few sessions on innovation particularly interesting. Dana Anderson of Genentech and Uwe Gottscwack of Lonza set the conference on the right track with their keynote presentations on Monday. Dr. Gottscwack discussed the dominant trends in biomanufacturing for the past few years, which include best practices in mammalian cell culture based manufacturing facility fit trends. He highlighted the trend that new facilities are smaller, modular, standardized and decentralized, and are employing lean manufacturing principles, and disposable and continuous processing technologies wherever possible.

Dr. Anderson discussed the challenges in developing Breakthrough Therapy Products. Once a product is granted Breakthrough designation by the FDA, Chemistry, Manufacturing and Control (CMC) activities often become critical path to filing the Biologics License Application (BLA). Dr. Anderson recommended focusing only on those process optimizations needed to launch, including launching with provisional specifications with an expectation to revise those specifications post-launch as part of the post-approval life-cycle management (PALM) plan. This may allow pivotal clinical studies to be performed with material from different scales and different manufacturing sites with the appropriate bridging comparability performed. Additional suggestions to streamline development were to fix pain points early in development and apply standard, i.e., platform, approaches to all development work where possible. It is expected that shelf life will be an issue for Breakthrough products, especially for global supply chains, because of the inability to compress real-time stability studies.

Kristen Manchester, a scientist in the Manufacturing Sciences and Technology group at Bristol-Myers Squibb (BMS) gave a terrific talk on BMS’s CMC experience with Breakthrough Therapy Designation. She stressed the importance of getting the Quality Target Product Profile (QTPP) defined ASAP so the team is laser-focused on activities needed to support the BLA. She corroborated that the CMC timeline must be compressed, which made BMS proceed in parallel for many activities normally done in series. As a necessity, they made significant improvements in efficiency and communication, and increased project resources and level of outsourcing to achieve these compressed timelines. They maximized efficiency by creating standard flow diagrams and nomenclature, and increased communication using standardized batch tables, which improved consistency throughout documentation.

Many talks gave a thorough overview of the multiple innovations being applied throughout the industry for both early phase development and commercial manufacturing. Clearly, CMC innovation and efficiency is still vitally important for the development and commercial maintenance of biopharmaceuticals. I expect the CMC sector of the industry will continue to transform how we traditionally develop and manage processes if not to gain a competitive advantage then surely out of necessity.

Share

Continuous Progress

Tuesday Apr 14, 2015

By Tom Ransohoff  (transohoffatbptcdotcom)  

One of the questions posed to our continuous processing panel at last week’s BDP Week in Huntington Beach, California was “What will it take for continuous processing to be adopted in GMP manufacturing processes?” The panel was comprised of scientists and engineers at the forefront of evaluating and implementing continuous processing in bioprocess applications (other panelists were Veena Warikoo of Genzyme, Benoit Mothes of Sanofi, Alex Brinkmann of Biogen Idec, and Veronique Chotteau of KTH and moderator Marc Bisschops of Pall [formerly Tarpon]). The consensus opinion from the panel was that a “change in mindset” was perhaps the most important hurdle, among those that remain for broader adoption.

I agree with this answer, but I couldn’t help but reflect on the slow but steady progress the industry is making in moving towards adoption of continuous processing methods. Much of the panel discussion at this year’s conference was devoted to practical aspects of implementation. Six or seven years ago, I participated in a similar panel where the focus was on whether continuous processing was economically viable or feasible at all in our industry. These are now more or less accepted – at least for some applications – and the questions have turned to how and where should we apply the technology. (Click here to reach our related blog from last summer).

Other signs of progress abound. During the conference, Pall announced its acquisition of Tarpon Biosystems and the related addition of the bioSMB platform to its product line. GE Healthcare recently announced an off the shelf version of its PCC system to enable semi-continuous chromatography with a standard system. Until recently, users were customizing Aktas to be able to operate in this mode. Finally, one speaker reported on implementation of a semi-continuous downstream process in a GMP manufacturing facility.

The reality is that adoption of new technologies is something that our industry can do – it just takes time. While most of the industry now accepts that single-use bioreactors can be used to manufacture not only clinical products but also some commercial ones, this was considered a dicey proposition only a decade ago. Risk-takers and early adopters needed to blaze the trail before the rest of us were convinced. We needed to see the overlaid cell growth plots between single-use and stainless steel bioreactors and many other data from case studies before getting comfortable with the approach. Product companies and vendors needed to collaborate to sort out problems that arose in early implementations, ranging from leachable/extractable issues to equipment design flaws. Now that many of these have been overcome, the industry is applying this technology far more broadly and reaping the rewards of adoption, including reduced capital investment and increased speed and flexibility in manufacturing operations.

I was encouraged by the constructive dialog around implementation issues for continuous processing at the BDP week. Although the specifics and the attendant benefits will most certainly differ from the industry’s adoption of single-use bioreactors, I expect a similar process to ensue as we learn how and when to use these powerful new approaches in our ever-expanding manufacturing technology arsenal. Continuous progress.

Share

Little-Known Factors That Affect COGS

Monday Apr 6, 2015

By Rick Stock  (rstockatbptcdotcom)  

As competition, product price sensitivity, and insurance drug coverage concerns for biopharmaceuticals increase, understanding cost of goods sold (COGS) has never been more critical. If you don’t have a keen understanding of your COGS, it could be detrimental not only to your product’s success, but to the success of your business as a whole, especially if you are a small, single-product company. Rather than crossing your fingers and hoping for the best, it pays to invest the time (and/or money) to develop a robust COGS model as early as possible in your product’s life cycle to fully grasp your product’s unique COGS.

There are many reasons to have at least a basic understanding of the COGS for your product. The single most important use of a COGS model is to determine a manufacturing price that will allow enough of a margin for a profitable market price. However, COGS models also inform ‘make vs. buy’ decisions to determine if you should build a facility or outsource the manufacturing of your product, and illustrate the impact (positive or negative) of new technologies or process changes on your overall manufacturing costs. COGS are also important in understanding costs and risks associated with unbalanced inventory of bulk drug substance or drug product.

Unfortunately, the methods for determining the COGS for biopharmaceuticals are not always clear and straightforward. So it is not surprising that many of us are not exactly sure which expenses should be included when performing this calculation. COGS categories are typically defined as materials, resources and hardware used to create the final product. If you’re struggling to calculate the COGS for your product, Table 1 outlines the six major cost categories and factors we routinely include in our COGS calculations.

Table 1. Major Cost Categories for COGS Calculations

Category

Can Include:

Materials (used per batch)

Media, Buffers, Water, Vials, Packing Materials, Single-use Components

Consumables (used across multiple batches)

Column resins, TFF Membranes

Labor

Operators, Supervisors, QA/QC, Admin, Facilities, Warehousing

Capital (depreciated over life of equipment and buildings)

Equipment and Facility

Overhead

Maintenance, Insurance, Taxes, IT, Training, Security

Utilities and Waste

Electricity, Fuel, Solid Waste, Treatment of Liquid Waste

As every product and cost accounting framework is unique, other hidden or forgotten cost categories worth considering might include: licensing expenses such as royalties and/or milestone payments, commercialization costs (advertising, sales labor, distribution chain) and research and development costs (amortized appropriately). All of these cost categories can significantly affect your COGS.

Now that you know the factors that go into COGS calculations, get started today. For more modeling tips and tricks, be sure to check our blog for future updates.

Share