Keyword Search
Free Preview
Login    Register   

Login to your account

No Account Yet? Fields marked with an asterisk (*) are required.

Please enter a valid Username. No spaces, at least 2 characters and must contain only letters and numbers.
Please enter a valid Password. No spaces, at least 4 characters and must contain only letters and numbers.
Passwords do not match.
Please enter a valid e-mail address.
E-mails do not match. ?>


Call for Articles

By purchasing an article in PDF format, you are agreeing to follow our Article Policy.

Use the "Buy Now" button to purchase an article.  Once checkout is complete, a download link will be sent to the email address that you provide during checkout.


Use the KEYWORD search located in the top left column to look for keywords, authors, and titles. If you still can't find what you're looking for, please This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Statistical Verification that One Round of Fluorescence-Activated Cell Sorting (FACS) Can Effectively Generate a Clonally-Derived Cell Line

by Lara E. Krebs, Jinxin Gao, PhD, and Christopher C. Frye, PhD
Volume 13, Issue 4 (Winter 2014/2015)

Mammalian cell line generation is foundational to protein-based therapeutic product development. Ensuring production cell line “clonality” (i.e., clonal derivation of the production cell line) is a requirement for product registration. Many single-cell deposition approaches have been developed since the inception of traditional limiting-dilution. However, regulatory expectations, in line with the capability of this original cloning technique, still lead many institutions to either execute multiple rounds of single-cell plating or conduct extensive screening immediately post-cloning to demonstrate the single-cell origin of a production cell line. Using fluorescence-activated cell sorting (FACS), we have developed a strategy to verify single-cell deposition that, when combined with statistical analysis, creates a highly-effective and efficient process for generating clonally-derived production cell lines in just one round of plating...

Citation:
Krebs LE, Gao J, Frye CC. Statistical verification that one round of fluorescence-activated cell sorting (FACS) can effectively generate a clonally-derived cell line. BioProcess J, 2015; 13(4): 6–19. http://dx.doi.org/10.12665/J134.Krebs.

Posted online January 20, 2015.

 
Characterization of a Lyophilized Immunoaffinity Chromatography Matrix Employed to Purify Hepatitis B Surface Antigen for Pharmaceutical Use

by Miguel Castillo et al.
Volume 13, Issue 4 (Winter 2014/2015)

Immunoaffinity chromatography is an indispensable purification tool. However, its use has been limited by cost, purification cycle numbers, and storage requirements. Therefore, authors speculated that a possible solution to these problems could be CB.Hep-1 monoclonal antibody (mAb)-immunosorbent lyophilization. This study sought to assess the impact of the CB.Hep-1 mAb quantification by enzyme-linked immunoadsorbent assay and the CB.Hep-1 mAb-immunosorbent lyophilization process for its impact on hepatitis B virus surface antigen purification for pharmaceutical use. Study results found that CB.Hep-1 mAb lyophilization did not affect mAb purity and antigen recognition capacity. CB.Hep-1 mAb-immunosorbent lyophilization did not modify volume-weight factor, infrared spectrum, particle-size distribution, particle density and viscosity, antigen adsorption capacity, antigen elution capacity, antigen recovery, antigen purity, gamma immunoglobulin (IgG) leakage, and purification cycle number. Therefore, the lyophilized CB.Hep-1 mAb and CB.Hep-1 mAb-immunosorbents can be successfully used for hepatitis B vaccine production...

Citation:
Castillo M et al. Characterization of a lyophilized immunoaffinity chromatography matrix employed to purify hepatitis B surface antigen for pharmaceutical use. BioProcess J, 2015; 13(4): 35–45. http://dx.doi.org/10.12665/J134.Valdes.

Posted online January 20, 2015.

 
Which Factors to Consider When Selecting an Analytical Method for Cell Culture Fermentation: A Comparison of Four Different Metabolic Analyzer Instruments

by Caitlin Kurtz and John Paul Smelko
Volume 13, Issue 3 (Fall 2014)

Mammalian cell culture processes require an in depth understanding of inputs and outputs in order to maximize productivity, efficiency, and product quality. Daily monitoring of essential metabolites, nutrients, and protein titer using at-line analyzers are the building blocks of drug manufacturing process development and characterization. In order to better understand how these instruments perform, a comparative analysis was conducted using two different classes of metabolicsensing technologies, membrane-based technology (MBT) and absorption photometric-based technology (APBT). Four commercially available instruments were examined using various samples and maintenance conditions in order to emphasize the following testing criteria: specificity, linearity, range, accuracy, and precision. Samples included standard solutions with known metabolite concentrations, cell culture supernatant, and supernatant liquid spiked with additional metabolite solutions. The results from our testing indicated that the photometric analyzers yielded more accurate and consistent results than the membrane-based analyzers and were easier and less time-consuming to maintain. Ultimately, these studies summarized the capabilities and limitations for both types of analyzers and provide a critical summary for instruments used in everyday bioprocess monitoring.

Citation:
Kurtz C, Smelko JP. Which factors to consider when selecting an analytical method for cell culture fermentation: a comparison of four different metabolic analyzer instruments. BioProcess J, 2014; 13(3): 12–31. http://dx.doi.org/10.12665/J133.Kurtz.

Posted online October 13, 2014.

 
Failure Mode and Effect Analysis (FMEA) as a Quality by Design (QbD) Tool for Managing Biopharmaceutical Product Development and Manufacturing Risks

by Mark F. Witcher, PhD
Volume 13, Issue 3 (Fall 2014)

This paper examines FMEA as a QbD tool. If FMEA’s strengths are used and weaknesses understood, it can be effectively used within a QbD feedback algorithm to identify, analyze, prioritize, and remediate biopharmaceutical development and manufacturing risks.

Citation:
Witcher MF. Failure mode and effect analysis (FMEA) as a quality by design (QbD) tool for managing biopharmaceutical product development and manufacturing risks. BioProcess J, 2014; 13(3): 39–46. http://dx.doi.org/10.12665/J133.Witcher.

Posted online October 13, 2014.

 
Contract Pharma Manufacturer Optimizes Quality Check Process With the Cubis Lab Balance

by Matthias Ude
Volume 13, Issue 3 (Fall 2014)

As a contract manufacturing organization (CMO) in this environment, it is essential for hameln pharma to deliver goods to their customers reliably, in terms of quantity, delivery time, and quality. Therefore, the topic of quality assurance plays a huge role— for both final packaged units as well as for bulk products. After a long-term analysis of the bulk product weighing process, hameln pharma’s objective was to significantly streamline the time-consuming process of manual counting and visual inspection. Moreover, taking cGMP standards into account, they wanted to optimize their existing process in order to remove any possibility of incomplete package volumes. Katrin Strasser, hameln pharma’s operational excellence expert, explained that: (1) packing box weights fluctuated with humidity levels during their manufacture; (2) labels for product packages varied; and (3) the actual number of items in a box carton were not always consistent.

Citation:
Ude M. Contract pharma manufacturer optimizes quality check process with the Cubis lab balance. BioProcess J, 2014; 13(3): 61. http://dx.doi.org/10.12665/J133.Ude.

Posted online October 13, 2014.

 
Validation Study of the Vi-CELL XR for Dendritic Cell Counting

by Iveta Bottová, PhD, and Lena Lee
Volume 13, Issue 3 (Fall 2014)

Dendritic cell (DC) population is a key functional constituent of cell-based immunotherapy drugs. The correct cell count and adequate viability of DCs are one of the quality control criteria for the final product release. The number of viable DCs is historically determined by microscopy using a manual counting method: Bürker chamber, and trypan blue dye for dead cell exclusion. The manual method can have significant variability between cell counts determined by different people performing the procedure, which may contribute to an unstable manufacturing process. The manual method is also timeconsuming for the operator. An automated cell counting process helps remove the variability between operators and can free up the operator for other tasks. The Vi-CELL® XR is an automated cell counting and viability analyzer that uses the trypan blue dye exclusion method. The Vi-CELL was evaluated as a suitable method for quality control of DC counts and viability for a dendritic cell-based biologic drug. The test for Vi-CELL counting accuracy was performed three times each on known concentration control beads, under the same operating conditions. The diameter and circularity of dendritic and lymphocyte cells was determined by a NIKON™ Eclipse microscope to set up the “correct recognition of DC. The size range for DC was established so that lymphocytes could be excluded. The number of total DC, viable and also non-viable, were analyzed and compared to Bürker chamber counting. There was no significant difference between the DC count obtained by Vi-CELL and by Bürker chamber. Vi-CELL automated cell counting was established as a method which is accurate and suitable for use with dendritic cells.

Citation:
Bottová I, Lee L. Validation study of the Vi-CELL XR for dendritic cell counting. BioProcess J, 2014; 13(3): 32–7. http://dx.doi.org/10.12665/J133.BottovaLee.

Posted online October 13, 2014.

 
<< Start < Prev 1 2 3 4 5 6 7 8 9 10 Next > End >>

Endorsed Events
Please update your Flash Player to view content.
Please update your Flash Player to view content.
Please update your Flash Player to view content.
Journal on iPad