October 2011

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.…

Toward Defined Culture Conditions for Pluripotent Stem Cells, Part 1

    On 31 March 2011, ~50 delegates attended a workshop organized by STEMCELL Technologies on implications of standard defined culture conditions for embryonic and induced-pluripotent human stem cells as part of the annual meeting of the UK National Stem Cell Network in York, UK. Researchers from both academia and industry need to develop a better understanding of those implications. Our company wanted to give them a better appreciation of key challenges facing ancillary material suppliers who manufacture standard defined…

From The Editor

      Not long ago I assembled a few current and former coworkers to meet with a young woman who is contemplating a career in journalism. Part of that visit involved comparing experiences of those who had been in the field for many years with those who had finished their formal education only a few years ago. We wondered whether the field still welcomes newcomers with degrees other than in journalism; or whether publishers now insist on that specific…

Product Life-Cycle Management

    Even before the advent of biosimilar products, biopharmaceutical products faced life-cycle concerns. The discovery–development–licensure process is just the beginning. Drug sponsors hope each new product will enjoy decades of relevance and generate millions of dollars in sales. But “me-too” products will come along, process technologies will change, and patents will expire. Even product innovators have to think about comparablity. Out-of specification results can signal problems that have their roots in raw material choices and sources, equipment deviations, analytical…

A Best-Practices Exchange with Solutions to Common Problems and Techniques for Next-Generation Products Formulation Strategies for Protein Therapeutics

Now in its 11th year, IBC’s Formulation Strategies for Protein Therapeutics is a must-attend annual conference for formulation, delivery, and analytical development scientists from biotherapeutic development organizations around the world. The 28 case studies to be presented at this year’s conference were chosen to offer solutions to the most pressing day-to-day challenges in formulation development for therapeutic proteins. Additional presentations address cutting-edge protein science from leading academics and include briefings on strategic issues of importance to this important field: Solutions…

Monoclonal Antibody Manufacturing

    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…