May 2008

Integration of Disposable Technology

The use of single-use components in the biopharmaceutical industry is not new. For more than a decade, a range of disposables have been available and commonly used — plastic film bioprocessing containers, microbial sampling bags, encapsulated filters, sterile connection devices, tubing, flasks, roller bottles and hollow-fiber membrane systems, to name a few. What began as a handful of individual components is now evolving into a category of preassembled, sterilized, and validated integrated disposable systems. The latest innovations to hit the…

Emerging Analytical Technologies for Biotherapeutics Development

A major goal of pharmaceutical development is to characterize pathways of chemical and physical instability and then to develop strategies to minimize them. Deamidation and oxidation are examples of the former, aggregation a result of the latter. The potential for the presence of multiple variants in protein-based pharmaceuticals highlights a need for analytical methods capable of reliably and accurately identifying and measuring those variants. The ideal analytical method would be sensitive, accurate, linear over a broad range, resistant to sample-matrix…

Recommendations for Extractables and Leachables Testing

Figure 1: SARTORIUS STEDIM BIOTECH (WWW.SARTORIUS-STEDIM.COM) Determination of extractables and leachables for disposable manufacturing systems must be addressed as part of process validation when single-use technology is used. The idea that compounds leach into pharmaceutical formulations or process fluids (e.g., buffer solutions and bulk storage) from processing and storage materials is not new or even unique to plastics. All materials have extractables and potential leachables. When properly evaluated, these are easily addressed and rarely lead to disqualification of a disposable…

Opening the Door to the Chinese Pharmaceutical Market

Virtually all aspects of the Chinese economy are booming, not the least of which is its pharmaceutical sector. Growing at 20% over the past five years, the $15 billion Chinese pharmaceutical market is predicted to become the world’s fifth largest by 2010 (1), making China an attractive place to do business for multinational pharmaceutical companies (MPCs). Rising living standards and improvements in China’s regulatory and technology infrastructure are the key drivers for this continued growth. Although all segments of the…

Guide to Disposal of Single-Use Bioprocess Systems

Single-use bioprocess systems can provide a range of environmental benefits beyond those of stainless steel systems. Although single-use systems may generate additional solid waste, benefits include reduction in the amount of water, chemicals, and energy required for cleaning and sanitizing as well as avoiding the labor-intensive cleaning processes required with stainless steel systems (1, 2). One of BPSA’s core activities is to educate users and develop guides on issues pertaining to single-use systems. The organization’s disposals subcommittee was chartered to…

Process Excellence

Life-science companies that adopt “quality by design” (QbD) into their overall operations are expected to achieve the “desired state” of manufacturing. So concludes the Q10 document from the EMEA, US FDA, and the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (1). The ability to achieve an appropriate quality outcome must be designed into each manufacturing process rather than companies relying on final product testing. An increased focus on QbD ultimately requires manufacturers…

Guide to Irradiation and Sterilization Validation of Single-Use Bioprocess Systems

Single-use bioprocess manufacturing systems increasingly are being implemented by the biopharmaceutical industry based on safety, time, and cost-reduction benefits. These disposable systems are used to process or contain fluids ranging from culture media, additives, and buffers, to bulk intermediates and final formulations. In many cases microbial control or sterility is required to ensure product purity and safety. Radiation sterilization is a common means of microbial control and sterilization applied to single-use systems. The standard methods for validating radiation sterilization are…

Secrets to a Successful Validation Project

Three major elements comprise validation projects in the biopharmaceutical industry: cost, schedule, and quality. If you can work within a budget, complete activities on time, and maintain regulatory-compliant documentation, then you significantly increase your chances for a successful validation project. Here we suggest ways you can improve these essential measurements with the help of a third-party validation team to achieve favorable outcomes. Team Selection The first key is building a validation team. Cohesion is critical for successful project management. All…

It’s Not Whether but Rather What and How to Implement

When considering integration of single-use technologies (SUTs or disposables) into a manufacturing process and facility, a number of criteria should be satisfied. These criteria govern both selection and implementation. Each criterion should be established by due diligence in which end-user requirements and the operation setting are considered carefully. Depending on a facility’s infrastructure and even a company’s business model, end users will define their criteria differently. Companies are driven to single-use technologies because of the simplicity and flexibility they impart…

Reconsidering the Supply Chain

An emerging challenge for biotech companies is understanding the bigger picture: How should manufacturing facilities be configured to link together process technologies? Should plants be highly flexible or focus on process standardization? How would a disruptive new technology affect current supply chains, and how could it be implemented? Meeting the challenge requires a complete and detailed understanding of supply chains. Much current focus in process development is on improving operations, with limited consideration to how improvements affect “big picture” variables.…