The BioProcess International September Issue - Now Available in Print, Digital and Mobile App Editions

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BioProcess International is dedicated to the application of biotechnology to industry, particularly to the development and manufacture of biopharmaceutical products including proteins, peptides, hormones, vaccines, gene therapies, cell and tissue therapies, and biodiagnostics.

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BioProcess International (BPI) announces the publication of the BioProcess International September 2013 issue featuring the following articles and special reports:

Focus on Regenerative Medicine

The components used to make a cell- and tissue-based product can vary greatly in source, complexity, and manufacturing. Ancillary materials can have a profound effect on the expansion, differentiation, or activity of a cell or tissue product and thus significantly affect its quality attributes. Ensuring the quality of a cell- or tissue-based therapeutic requires rigorous evaluation of the components used in its manufacture. As the authors report in this article, USP test specifications and physical reference standards can help.

Special Report: Protein A

Because of the inherent and engineered variations in therapeutic antibody structures, there is no “one-size-fits-all” when it comes to techniques for MAb purification. The closest anything has come to this is evidenced by the success of protein A affinity chromatography, which has become the workhorse for antibody production. But it is not the perfect solution. Some experts refer to new alternatives as “disruptive,” while predicting that protein A will continue to be used for commercial-scale MAb purification throughout the foreseeable future. In this article, Blanca Lain looks at the history of protein A in MAb purification (also drawing on responses from a BPI survey) and explores various perspectives on its continued role in bioprocessing as well as potential alternatives.

BPI Lab: Spectroscopy

Well known for its utility in raw-materials testing, spectroscopy has extended itself throughout bioprocess development in various forms (e.g., NMR , Raman, and FTIR). In this article, senior technical editor Cheryl Scott explores the history, commonly used methods, and many applications of spectroscopy in biopharmaceutical development. She identifies a number of examples of its use in previous BPI articles and points to some meetingplaces for learning and sharing more about it.

Evaluating Anti-HCP Activity

Biologics require accurate monitoring and effective removal of process-derived impurities. Among those, host-cell proteins (HCPs) may be the most challenging because an expression system’s proteome involves thousands of different proteins, some of which can copurify with the drug. Multianalyte assays need to detect most protein impurities that could be present. In this article, authors from Bio-Rad and a Chinese research institute present enhancements to the standard two-dimensional electrophoresis and Western blotting workflow. They apply these enhancements as a model example to evaluate a commercially available anti-HCP antibody reagent.

Process Monitoring and Control

Commercial inline sensor systems can monitor process parameters such as pH or dissolved oxygen concentration in real time. For other parameters — e.g., glucose concentration, total cell count, and viability — no robust online prediction is yet possible for many applications. The gap could be closed using NIR spectroscopy, which provides quantitative prediction of single analytes in real time. In this article, academic and supplier authors describe evaluation of a new free-beam NIR spectrometer for monitoring and control of a mammalian cell cultivation processes.

Comparability Step by Step

With upstream chemistry analysis (UCA), the chemistry profile of cells screened in a process development environment can be identified early on using very small (microliter-scale) samples. In this article, Daniel Allen describes UCA technology adapted from hospital diagnostic laboratories using instruments already in most pharmaceutical laboratories. This could offer new parameters with which to select promising candidate cell lines.

Also Available Online-only in the BPI Extra section of

Ask the Expert: Culture Media: Sourcing Animal-Free Raw Materials

For September’s online exclusive, we talked to Bill Whitford (senior manager of the bioprocess market for Thermo Fisher Scientific) about sourcing animal-free raw materials for cell culture media. This has become a requirement for many biopharmaceutical sponsors, but it is not without its issues. But what precisely is meant by animal is not always clear. Regulatory guidance is sparse on this issue. And a designation of animal-derived–component free (ADCF) often involves additional certification, testing, or auditing. Sponsors and material suppliers struggle with such issues as material handling, cross-contamination, packaging, adhesives, and facility cleaning validation. Questions can remain regarding second- and third-level material and supplier standards. And in attempting to apply a science and risk-based approach to clarifying the ADCF issue, the industry needs to determine precisely what risk the designation is intended to prevent.

Best of BPI Revisted – Reducing Tech-Transfer Risk

Process understanding is the key to mitigating risks associated with technology transfer. In 2007, Justin Neway provided strategies for combining on-demand data access, trending, reporting, and analytics to achieve that understanding throughout process development. With increasing adaptation of process analytical technology (PAT) and quality-by-design (QbD), process understanding strategies have shifted.
In an audiocast with managing editor Maribel Rios, Neway reviews how modern approaches are helping companies reduce tech transfer risk and increase product quality in real-world applications. He discusses advances that have made it easier to identify, reduce, and control risk. Neway focuses on issues that remain in process monitoring and control (such as the needs of in-house information technology) and those that have come up since 2007 (such as the needs of multiproduct manufacturing).

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About BioProcess International

BioProcess International™ ( is a monthly, controlled-circulation magazine devoted to the development, scale-up, and manufacture of biotherapeutics and biodiagnostics. Each issue provides the global industrial biotherapeutic community with up-to-date, peer-reviewed information detailing the business, politics, ethics, applications, products, and services required to successfully drive biopharmaceuticals, vaccines, and biodiagnostics through the development and manufacturing process.

BioProcess International™ is part of the IBC Life Sciences Division of Informa, plc, a leading international provider of specialist information and services for the academic, professional and business communities. Informa offers a world-class portfolio of publications, events and data services for researchers, students, lecturers and professionals in the academic and scientific communities worldwide.

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Damon Mastandrea
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