Continuing the theme of this occasional series, we examine the role of manufacturing in the supply chain in terms of what is required to deliver affordable medicines to patients. The industry has debated the relevance of manufacturing costs in the overall big picture (1). Rising manufacturing costs as a proportion of the overall selling price coupled with increased competitive pressures creates a strong drive to reduce manufacturing costs. However, cost of goods (CoG) is not the only strategic…
2011
Limited Analytical Technologies Are Inhibiting Industry Growth
Progress in the development of bioprocessing-related assays and analytical instrumentation has not kept up with industry demands. The industry wants analytical technologies (especially for single use) to help improve productivity, optimize and monitor processes, provide real-time product quality control, and characterize biosimilars. These trends are reflected in our recent survey data. Over 30% of biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) have expressed demands for improved assays and analytical equipment (1). BioPlan Associates’ eighth annual survey of biopharmaceutical…
A Brief History of Perfusion Biomanufacturing
Today’s renewed interest in perfusion culture is due to an increased awareness of its advantages, some general improvement in equipment reliability, and a broadening of operational skills in the biomanufacturing industry. Some misperceptions persist, however, according to a 2011 review by Eric Langer (1). Our view here of the history of perfusion and fed-batch processes includes some discussion of technological process improvements and challenges that the bioprocess industry faces. A team of authors at Serono in Switzerland wrote…
Biosimilars in Development
The 2009 Biologics Price Competition and Innovation Act (BPCIA) provided the bioprocessing industry with the legislative pathway toward approval of biosimilars. US Food and Drug Administration information regarding how it will translate that legislation, however, had been limited until an August 2011 article finally provided some insight on how those guidances might actually play out (1). As expected, the agency appears to be implementing a science-driven approach, with sponsor companies needing to apply complementary orthogonal analytical methods to…
Use of Blast Freezers in Vaccine Manufacture
Vaccines are powerful and cost effective prophylactic tools for protecting public health. The Global Alliance for Vaccines and Immunizations (GAVI) estimates that ~5.4 million lives are saved each year by the administration of vaccines for hepatitis B, measles, haemophilus influenza type B (hib), pertussis (whooping cough), yellow fever, and polio (1). According to the World Health Organization, seasonal influenza alone claims 250,000–500,000 lives every year globally, many of which could be prevented by more widespread vaccination with the…
Evaluating Disposable Depth Filtration Platforms for MAb Harvest Clarification
At small to medium scales, single-use technology offers significant advantages over traditional reusable (e.g., stainless steel) manufacturing technology with regard to flexibility, cost of goods, implementation timelines, and maintenance. However, process design based on disposables does create new challenges. With traditional fed-batch processes, harvest clarification is usually achieved by centrifugation followed by depth filtration. For processes based entirely on disposables, the disc-stack centrifuge needs to be replaced by filtration alone. To extend its manufacturing capabilities and capacities, Rentschler decided to…
Scaling Up Normal-Flow Microfiltration Processes
Scaling up biological processes from laboratory bench to process scale is complex and requires considering a number of factors to ensure process robustness. Due to variability among raw materials and processes, most process developers use generous safety factors to ensure that their systems are not undersized. Although that method can be reduce process risk, it is inefficient. To improve process efficiency and reduce risk, we conducted a study to identify and quantify key factors that contribute to variability…
Optimization, Robustness, and Scale-Up of MAb Purification
The biopharmaceutical industry needs faster and more efficient development of new drugs and their market introduction as well as shorter process development times for both upstream and downstream operations. It has become more commonplace to use high-throughput development techniques to save time (1). Development is also sped up by applying platform technologies based on the unsurpassed selectivity of protein A resins (2,3,4,5,6), which is the foundation for downstream processing of monoclonal antibodies (MAbs). This is the second of two articles…
GLOBAL MARKETPLACE
Antimicrobial Incubator Product: Multitron incubator shaker Applications: Cell line screening and seed cultures for larger validated processes Features: ATR has added an optional antimicrobial coating to the interior of its Multitron incubator shaker cabinet. This exclusively formulated coating inhibits the growth of bacteria, molds, and fungi over 100,000-fold. The coating is safe, effective, long-lasting, and approved for use in medical and food industries by independent certification. It is applied in production and can be ordered with any Multitron unit. All…
Exchanging Real-World Solutions to Improve Speed, Cost, and Predictability BioProcess International Conference & Exhibition
The BioProcess International Conference is where challenges are explored, solutions are uncovered, and opportunities are developed, making it the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing. Save time and reduce cost of goods with tips on streamlining processes and implementing novel technologies. Find new collaborators and partners with superior networking opportunities at the industry’s largest event devoted solely to biopharmaceutical production. Consult with >150 providers of novel and practical services and products in the exhibit hall.…