Saturday, September 1, 2012 Daily Archives

Recovery and Purification

    Modern separation and purification engineers are hard tasked with handling concentrated feed streams, recalcitrant proteins, and new contaminant profiles coming from the use of serum-free culture media. With regulatory, public, and industry attention increasingly focused on the subject of viral safety, for example, a risk-based approach following an FDA quality systems initiative continues to build momentum. That regulatory perspective affects how recovery and purification unit operations are designed and conducted. Process modeling software is becoming increasingly sophisticated, so…

QbD for Biologics: Learning from the Product Development and Realization (A-MAb) Case Study and the FDA OBP Pilot Program

    Cosponsored by CASSS (an international separation society) and the FDA, the 23rd CMC Strategy Forum was held in Bethesda, MD, on 19–20 July 2010. For the third time, this forum explored the topic of quality by design (QbD) for biologics. The first such forum was held in July 2007 and focused on establishing a general understanding of QbD terminology and concepts. In July 2008, the second discussed approaches for submission of QbD data and associated regulatory implications. Building…

Cell Culture and Upstream Processing

    Cell culture processes are a vital part of manufacturing, yet the bioprocessing industry still needs optimized process development approaches. Increasing interest in chemically defined media, perfusion cell processes, and high-throughput approaches are driving the need for better understanding of cell culture characterization and process development for current and next-generation protein therapeutics.     Process Development   Optimizing the business process of cell line development involves creating competitive advantages with increased efficiency and reduced risk. “Intelligent business practices that…

Creating a Corporate Compliance Program

    Regulatory compliance is an evolving concept that must be flexible enough to adapt to both a company’s unique business climate and to changing regulatory circumstances. Although standard operating procedures (SOPs) are a compliance tool and can and should be strongly recommended, they cannot become the end of a process. Compliance is not a set of standards or procedures that sit on a shelf until something goes wrong. Instead, compliance requires thought in creating a code of conduct and…

Scale-Up of Single-Use Depth Filtration Systems

Process development engineers are responsible for developing scale-up strategies for efficient and cost-effective manufacture of biological and bioprocess-derived products at bench-scale, pilot scale and at manufacturing scale. A central unit operation in the production of these various therapeutic proteins is cell clarification using depth filtration. Recently, single-use depth filtration technologies have been developed, at scales ranging from the lab, to R&D, process development and on to manufacturing.

In this educational webcast, Laura Brown, Scientific Application Support Specialist II with 3M Purification, will provide guidelines for scaling-up of single-use depth filtration systems, and will review the commonly used single-use depth filtration products used for biopharmaceutical manufacturing.

ROUNDTABLE – Single-Use Technologies: Industrialization, Standardization, Regulation – Common Goals and Differing Expectations

As the adoption and maturation of single-use technologies continues to evolve, many end-users are looking for single-use suppliers to standardize products, materials, and equipment in order to improve efficiency and lower costs. An expert group of industry suppliers discusses the pros/cons and differing expectation surrounding this trend.