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 BioProcessintl.com:
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™ (http://www.bioprocessintl.com) 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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