In the United States, up to 40% of businesses affected by a natural or human-caused disaster never reopen (1). The biopharmaceutical industry is not immune from disasters of a dizzying variety. But biotechnology companies often put all their supply needs in one proverbial basket. Companies need to understand fully the ramifications of contingency planning for single product lines. Imagine having to set up distribution and shipping plans for multiple products with different environmental needs, for shipping to different markets, and…
Manufacturing
Sponsors Look to Asia for Potential Contract Partners
As the biopharmaceutical market continues its global expansion, biomanufacturers are becoming increasingly comfortable with the idea of outsourcing activities to international destinations. This year, China expanded its lead as the primary potential destination. This measure of interest shows how the country’s international outsourcing potential and global perception have changed over the past five years. It also suggests a greater international awareness of opportunities opening up in China for local production. Figure 1: () More than a quarter (26.2%) of the…
Analysis of Bacterial Biomass Growth and Metabolite Accumulation
Mathematical modeling has been widely used in microbiology and biotechnology for several decades. The main objective of modeling is to find optimal conditions for microbial growth and biosynthesis of useful metabolites. We modified the well-known equation of Perth–Marr (1) — proposed to calculate the energy consumption of a substrate— to analyze the energy consumption by cells for growth and viability maintenance. Our study includes that theory along with our own development. Our initial modeling work was carried out with Yersinia,…
Process Optimization of Biosimilars Production Using NMR Profiling
With a compound annual growth rate potential of ∼52% during 2010–2015 (1), the global biosimilars market represents a significant driver in biologics development and manufacture. Increased competition, quality-by-design (QbD) directives, and rising costs are compelling biosimilars manufacturers to search for advanced technologies they can use in optimizing production processes to remain competitive and maximize new opportunities. Here, we discuss biomanufacturers’ needs for robust, standardized cell-culturing procedures that comply with QbD directives. We also describe an effective new NMR-based bioanalysis technology.…
Rapid Detection of Pandemics
A Coronavirus — like severe acute respiratory syndrome (SARS) — is back in the headlines. On returning from a trip to Saudi Arabia in summer 2012, a Qatari national was struck down by a mystery respiratory illness. Because of inadequate diagnostic capabilities, the patient was transferred from Qatar to London for intensive-care treatment and diagnosis. The UK Health Protection Agency (HPA) confirmed infection with the same Coronavirus strain discovered by a Dutch team following the death of a Saudi national…
Multiproduct Facility Design and Control for Biologics
Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans. A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a…
A Framework for Process Knowledge Management
Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects between groups within an organization can be aggravated by a lack of common terminology and poor data-management practices. Implementing a simple data model based on the ISA-88 standard for batch control can help companies capture process and facility data throughout their product life cycle (1). The first half of this two-part article illustrates how translating a process description to a structured electronic format could transform the bioprocessing…
Safety, Flexibility, and Efficiency
International pharmaceutical and biotech companies are demanding solutions for current and future challenges of their industries — solutions that will stand the test of time while offering significant advances over current manufacturing techniques. Modern and highly proficient production lines for commercial manufacturing of parenteral drugs can represent a crucial criterion in the success of these companies. New and innovative high-speed filling lines for prefilled syringes present an excellent opportunity to meet current production demands. Following is an example…
Efficient, Flexible Facilities for the 21st Century
A number of recent improvements in the engineering of high-titer expression vectors, in biopharmaceutical process development, and in facility construction have converged to present new opportunities for cost-effective, flexible, biomanufacturing facility construction. The evolution of requirements for biopharmaceutical facilities is driven by globalization of the biopharmaceutical industry, patent expirations of several blockbuster biopharmaceutical products, and the increasing shift in new product development away from blockbuster drugs and toward more personalized, niche products. An increase in product approvals (primarily…
Developing an Integrated Continuous Bioprocessing Platform
Continuous upstream processing (perfusion) is not a new concept in the bioprocessing industry. Genzyme, Bayer, Centocor, and other companies have been implementing perfusion processes for many years. However, interest is now growing for extending this concept to downstream operations to create fully integrated continuous processing. During the past year, Genzyme has presented on and published about its advancement toward the development of an integrated continuous system (1). The company has completed proof-of-principle development at laboratory scale with different…