BioProcess Blog |

By Patricia Seymour

The results from BPTC’s bioPULSE survey on vaccine manufacturing highlight industry predictions for new technologies and risks involved in vaccine manufacturing.

The two most prevalent technological advances expected to have the greatest impact on vaccine manufacturing in the next 5 years are flexible manufacturing and novel delivery systems. Respondents indicated that microbial fermentation, followed closely by mammalian cell culture, are the two technologies best suited to develop new or pandemic vaccines. Compared with mammalian cell culture, microbial fermentation has the advantage of relatively short production cycles and low cost. However, several new, highly effective vaccines are being developed using mammalian cell culture to overcome limitations of traditional egg-based production systems. Application of Quality by Design (QbD) and Process Analytical Technologies (PAT) are also rapidly gaining acceptance in all aspects of biomanufacturing, according to a majority (73%) of respondents. Formulation development (44%) and downstream purification (44%) would benefit far greater than upstream processes (12%) from application of QbD according to respondents. (Share your thoughts on QbD in our current bioPULSE survey!)

Nearly half think access to manufacturing capacity is the greatest risk factor in meeting global demand for vaccines. As the patients in emerging markets are able to access these lifesaving medicines more routinely, vaccine use is expected to increase significantly in the coming years. Recognizing the growing need for new vaccines, two-thirds of the survey respondents indicated that they are either currently developing or plan to develop vaccines. The overall vaccine market has seen growth rates of up to 10% in the past few years fueled by wider use of current vaccines and introduction of new vaccine therapies. Compared to the 5% growth for the overall pharmaceutical industry, the vaccine market should continue to be a bright spot.

One third of respondents are planning to increase the use of disposable technologies in order to allow manufacturing facilities to be rapidly and cost effectively established locally in emerging markets. Only small percentages (4%) of companies are out-licensing vaccine products to companies in emerging markets. This low percentage is most likely due to concerns about protection of intellectual property and manufacturing know-how.

To ensure that new vaccines can reach the patients who need them, it is important for global regulatory agencies not to set divergent requirements for the approval of vaccines in their territories, which ultimately could increase the cost and time to commercialize vaccines, or worse, disincentivize manufacturers from marketing their vaccines in certain territories. It is not surprising that the majority, 64%, of survey respondents indicated that governments should fund the research and development of pandemic vaccines. This may be controversial in some circles, but without government support, most not-for-profits could not provide the funding needed to bring a vaccine completely through its development cycle, and for-profit companies have little or no incentive to develop pandemic vaccines if there is not a guaranteed market (i.e., governments).

The objective of all bioPULSE^TM surveys is to obtain relevant and focused feedback on topics of interest to the biologics manufacturing community. The web-based surveys are quick, short, and rewarding (everyone who participates will be emailed a summary and analysis of the aggregate results), so we hope you will join the growing bioPULSE community and contribute your insight.

Join Patti Seymour, Senior Consultant, at the10th Biosimilars Americas conference, to be held March 13-15, 2012 in Boston, MA to learn more about manufacturing strategies for biologics, biosimilars and novel therapies.​ To pre-arrange a meeting with Ms. Seymour at the conference, please click here  (pseymourbptccom)  .

by Howard Levine  (hlevinebptccom)  

With the continued growth in sales and number of products, the biopharmaceutical industry is rapidly becoming the driver for the overall pharmaceutical industry. In this fully documented and referenced report we draw from our proprietary Biopharmaceutical Product database to analyze the continued growth of biopharmaceutical sales. We review the production methods used for these products and analyze the impact of those produced in mammalian cell culture on global manufacturing capacity. Despite the continued growth in sales of biopharmaceutical products and the associated requirement for increasing mammalian cell culture capacity to meet this market demand, we find that overall capacity utilization rates have remained low and forecast that average industry-wide capacity utilization will increase approximately 50% from 2011 to 2016 as construction of new capacity slows and more products reach the market.

The impact of this increasing utilization rate on biomanufacturing capacity and the current concentration of this capacity in a small number of companies may limit some companies’ ability to access capacity in a timely manner. While the five product companies controlling the majority of cell culture manufacturing capacity have more than enough capacity to accommodate their anticipated future needs and keep their own utilization rates low, many of the remaining companies, which either have smaller-scale manufacturing capacity or are relying on CMOs, may find a need for additional capacity by 2016 suggesting that CMOs and smaller biopharmaceutical companies may announce the installation of new capacity in the coming years.

The 150-page State of Mammalian Cell Culture Biomanufacturing report provides a comprehensive analysis of the current and future supply and demand for mammalian cell culture capacity, including the geographic distribution of manufacturing capacity, the impact of facility utilization rates on overall capacity requirements, and the influence of emerging technologies on manufacturing facility design and utilization. With detailed figures, graphs, and tables highlighting including a comprehensive list of sales data and bulk product requirements for all biopharmaceutical products produced in mammalian cell culture currently on the market, Unlike other qualitative surveys or unreferenced articles on biomanufacturing, The State of Mammalian Cell Culture Biomanufacturing provides detailed, data-driven insight into the mammalian cell culture manufacturing market to inform senior executives and program managers with the essential and timely information needed to fully understand the mammalian cell culture manufacturing landscape and to stay competitive.

​The Annual bioProcessUK Conference is one of the leading technical meetings for bioprocessing professionals in the UK. BPTC is pleased to be participating  in this year’s event to be held Nov 30 – Dec 1 at the Glasgow Science Centre.  Dr. Howard Levine  (hlevinebptccom)  , President and Principal Consultant, will be delivering a keynote lecture on the changing landscape of mammalian cell culture manufacturing capacity and Dr. Susan Dana Jones  (sjonesbptccom)  , Vice President and Senior Consultant, leading a workshop on Quality by Design. Please join Drs. Levine and Jones at this year’s event; to schedule time with either of them at the conference, please click here  (hlevinebptccom)  .