Chinese hamster ovary (CHO) cells are a common and stable option for mammalian expression systems, but what are the other cell line options in upstream processing and how do they compare in quality and stability to CHO cells? And what are the best techniques for ensuring quality and stability in cell-line development?  

 spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances and the analytical techniques companies can use to ensure quality and stability.

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BioPharm International spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances.

Cell Line Quality Technologies

	Every biopharm company conducts investigations for undesirable outcomes related to safety, quality, and reliability of product and processes. The question is to what degree do these investigations support or hinder performance excellence? A sub-team that was formed as part of the BioPhorum Operations Group (BPOG) human performance workstream sought to answer this question. The findings suggest that biopharm is behind other industries with respect to investigation best practices. This article provides a pathway for the industry to improve its investigations, and in so doing, improve overall organizational learning and performance.

Are investigations supporting or hindering performance excellence?

Investigation Effectiveness Drives Human Performance Excellence

Manufacturing systems should be designed using the principles of good documentation practice to ensure data integrity. Industry experts describe issues with validating, using, and auditing paper and electronic records. Records must meet the core principles of ALCOA+ (data must be attributable, legible, contemporaneous, original, accurate, complete, consistent, and enduring).

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

Data Integrity Challenges in Manufacturing

Manufacturing equipment, technologies, and processes need to constantly evolve. Technical personnel from Janssen Supply Chain (JSC) and consultants from KPMG's Global Strategy Group discuss a technology management process to identify and evaluate new technologies in biopharmaceutical manufacturing to aid business decisions and improve supply chain capabilities.

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.

Evaluating Technology and Innovation in Biopharmaceutical Manufacturing

The development of a biosimilar product requires extensive structural and functional characterization at many stages. At the functional level, pharmacologic activity should be evaluated by appropriate 

 assays in a comparative sense, to provide evidence that the activity and potency are similar, supporting data from structural characterization.

 potency assays, however, can be expensive and time consuming, with readouts that are often far downstream of the initial drug/target interaction. Cell-based assays, with a readout proximal to the initial target, can be an attractive alternative. The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.

The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.

Seeking Accelerated Biosimilar Characterization

	Plant transient expression offers a flexible approach in drug development and enables rapid production and scale up of therapeutics.

Plant-Made Pharmaceuticals—Accelerating Drug Development Globally

Cell viability in a bioreactor can be measured in real time in a bulk vessel. Measurements can be done on-line via a bypass loop, inline (inside the vessel), and offline, wherein the measurement device is disconnected physically from the vessel, experts from Sartorius including Stuart Tindal, PhD, product manager, PAT and automation; Jochen Scholz, PhD, senior scientist, R&D instrumentation and control; Mario Becker, director, PAT and automation; and Marek Hoehse, PhD, senior scientist, R&D spectroscopy and MVDA, recently told 

. These individuals, along with John Carvell, PhD, sales and marketing director of Aber Instruments Ltd., and John Gleeson, director at process sensor sales at Hamilton Company, spoke with the publication to explain how to best measure cell viability in a bioreactor and ensure that process parameters stay stable.

Experts discuss recent advances in cell viability testing methods in bioreactors.