2012 PRESENTATIONS.
In the past five years, technological advances in manufacturing processes, improvements in expression levels, widespread acceptance of single-use bioreactors, an increase in biosimilar development throughout the world, and consolidation in the pharmaceutical and biopharmaceutical industries have resulted in significant changes in the supply and demand of mammalian cell culture manufacturing capacity. Currently, the vast majority of global mammalian cell culture manufacturing capacity is controlled by just a few biopharmaceutical companies. As a result, access to capacity and utilization of manufacturing capacity varies considerably throughout the industry. This presentation will discuss current trends that will influence the growth, availability, and utilization of cell culture capacity in the coming years and provide insights into the future of global biopharmaceutical manufacturing.
The impending patent cliff for many high-value innovator biopharmaceutical products offers significant opportunities for biosimilar companies, whose market is estimated to grow from $243 million in 2010 to $3.7 billion by 2015 in the United States, Europe, and Japan1. One primary success factor for individual companies will be access to biopharmaceutical development and manufacturing capacity, and determining the overall demand and the corresponding capacity requirements for emerging biosimilars can be difficult. In order to decrease cost of goods and maximize returns on investment, biosimilar companies must determine whether to invest in their own manufacturing capacity or outsource the manufacturing to a contract manufacturing organization (CMO). This presentation will explore the effect of biosimilar development on overall manufacturing capacity and will evaluate strategic options for individual biosimilar companies.
1 Datamonitor. Pharmaceutical key trends 2011 - biosimilar market overview [Internet]. London (GB): Datamonitor; 2011 Feb [cited 2011 Jun 28]. 6 p. Available from: http://www.datamonitor.com/store/Download/Brochure/?productId=HC00062-006.
2011 PRESENTATIONS.
Recent technological advances in manufacturing processes, improvements in expression levels, widespread acceptance of single-use bioreactors, an increase in biosimilar development throughout the world, and consolidation in the pharmaceutical and biopharmaceutical industries have resulted in significant changes in the supply and demand of mammalian cell culture manufacturing capacity. Currently, the vast majority of global mammalian cell culture manufacturing capacity is controlled by just a few biopharmaceutical companies. As a result, access to capacity and utilization of manufacturing capacity varies considerably throughout the industry. This presentation will discuss current trends that will influence the growth, availability, and utilization of cell culture capacity in the coming years and provide insights into the future of global biopharmaceutical manufacturing.
While the diverse technology platforms used for the production of vaccines make it difficult to standardize facility design and equipment, recent advances in bioprocessing technology will have a definite impact on vaccine manufacturing in the future. The rapid advance of single-use and disposable technologies for rapid and efficient production of vaccines coupled with increased development of cell culture based methods for their manufacture will enable smaller, more flexible facilities. This presentation will provide an update on vaccine manufacturing world-wide and discuss the influence of new manufacturing technologies and processes on vaccine manufacturing. Based on current trends in vaccine manufacturing and the development of single-use and disposable technologies, a concept for modular vaccine manufacturing facilities allowing maximum flexibility and rapid construction will be presented.
Having a robust supply chain and accurate forecasts from patient to bulk API is critical for efficient planning of clinical trials supplies. An overview of best practices for supply chain management will highlight the areas to be most concerned with for clinical supplies. A comparison of different technologies available for clinical supply planning and forecasting will be made and recommendations will be given for how best to manage these technologies whether in-house or through a third party.
Most biopharmaceutical products are manufactured using “tried and true” batch processing methods, which are effective but inherently less capital-efficient than continuous processing methods. Adoption of continuous processing approaches presents challenges, including regulatory uncertainties and the design and complexity of conventional continuous-processing equipment. This talk will focus on approaches that may be used to address these challenges and realize implementation of continuous processing technologies for biopharmaceutical manufacturing.
At the end of the 20th Century, biomanufacturing output was limited by factory capacity and process bottlenecks, so companies launched technology and process initiatives to improve productivity. Today, such improvements, as well as mergers and globalization, have produced overcapacity, controlled by the largest firms, with supply and demand mismatches that can limit smaller companies’ access to production. This presentation reviews trends in industry-wide mammalian cell culture capacity and utilization as well as trends in biomanufacturing technologies to address evolving market requirements.
At the end of the 20th Century, biomanufacturing output was limited by factory capacity and process bottlenecks, so companies launched technology and process initiatives to improve productivity. Today, such improvements, as well as mergers and globalization, have produced overcapacity, controlled by the largest firms, with supply and demand mismatches that can limit smaller companies’ access to production. Furthermore, existing large-scale capacity is poorly suited to the low-volume, niche products that are the future of biopharmaceuticals. Hear experts discuss economies and diseconomies of scale, technology barriers and breakthroughs, shifting bottlenecks and the promise of low-volume, just-in-time distributed manufacturing.
Commercialization of hESC-derived therapies will require the development of appropriate policies, procedures, and processes to address the large-scale GMP manufacturing, quality, and regulatory challenges of successfully bringing these new products to market. This presentation will discuss the parallels between hurdles faced today in the manufacture of cell therapy products with those faced by the biotechnology industry in the early days of monoclonal antibody protein production. As with the manufacture of monoclonal antibodies, the establishment of platform processes for the manufacture of hESC products and the adoption of single-use technologies for their production will enable companies to develop reliable, robust, and economically viable manufacturing processes for these products. Using estimates for the anticipated patient populations, dosages, and market penetration of hESC-derived therapies currently under development, it is clear that the scale of production required for these products fits nicely within the realm of current manufacturing technologies.
Whether these transfers occur within a company or between different organizations such as from a company to a service provider, careful planning and management is essential to ensure the knowledge and experience gained during development and/or early clinical manufacturing is effectively transferred so that the receiving organization or party can perform the critical elements of transferred methods or process. The sending and receiving parties must be well aligned in expectations and plans. This is facilitated by early and detailed planning and communications. The better the process and product are understood in terms of CQAs and CPPs the greater the likelihood of a successful transfer and demonstration of comparability. Risks should be identified and controlled as best as possible. This presentation discusses each of these technology transfer considerations to enable a smooth and successful technology transfer process.