mammalian cell culture – BioProcessing Journal

Beyond the Stainless Steel — The Real Capacity Crunch…

How do we ensure that the next generation of biotech medicines can be brought to market in a timely way, that they continue to be safe and effective and — of growing importance — are affordable by healthcare funding agencies, and profitable to the companies developing them?…

Biologics Production

biologics production biopharmaceutical biopharmaceutical prices contract manufacturers mammalian cell culture monoclonal antibody pharma stakeholders production capacities recombinant proteins stainless steel bioreactors

Viral and Prion Clearance Studies

A major concern for medicinal products of biological origin is the potential risk of contamination with known or unknown viruses. Manufacturers of biopharmaceutical products (such as recombinant proteins and monoclonal antibodies, or products derived from blood, tissue, or urine) are required to assess the ability of their manufacturing process to produce a product that is safe for use in humans…

Biologics Production

biologics production biopharmaceutical host cell proteins mammalian cell culture monoclonal antibody prion clearance studies product contamination recombinant proteins transmissible spongiform encephalopathy tse viral clearance studies

Facility Design for Contract Manufacturing

The number of mammalian cell-culture based products is increasing rapidly and has the potential to out-pace the current production capacity. New facility construction for mammalian cell culture production is costly and time consuming. Planning for initial product launch and long-term commercial manufacturing can be daunting for promising products in late phase clinical trials…

Biologics Production

biologics production biopharmaceutical clinical trial materials cmo commercial manufacturing organzations contract manufacturing organization facility design mab mammalian cell culture monoclonal antibody single-use bioreactor

Best Practices for Optimization and Scale-Up of Microfiltration TFF Processes

Tangential flow filtration (TFF) is widely used in biopharmaceutical processing for protein purification – a common application for TFF is ultrafiltration for concentration/diafiltration of proteins. In this type of application, the product protein is retained (concentrated) within the feed side of the ultrafiltration membrane, while the buffer components and other small impurities (smaller than the membrane pore size) freely pass through the membrane into the permeate side. Several scholarly articles are available in literature which discuss the ultrafiltration application as well as its optimization strategies. Another category of application where TFF finds significant use is in the clarification of cell culture bioreactor and microbial fermenter feed solutions using microfiltration membranes. In some of these microfiltration TFF applications (e.g., mammalian cell culture clarification), the product (protein) freely passes through the microfiltration membrane and is recovered on the permeate side, while the contaminating impurities (cells, cell debris, colloids) are retained on the feed side of the membrane. In certain other microfiltration TFF applications (allantoic fluid clarification in egg-based flu process), the product (flu virus) may get concentrated on the feed side of the microfiltration membrane (similar to an ultrafiltration step), while the contaminating impurities (ovalbumin, etc.) may get removed into the permeate side…

Biologics Production

allantoic fluid clarification bioreactor clarification flu firus mammalian cell culture membrane pore size microfiltration protein purification tangential flow filtration tff ultrafiltration

Virus Clearance in Your Process from Start to Finish

The safety of biological products (biologics) derived from in vitro cultured cell lines of animal origin is dependent both on clinical studies to evaluate efficacy, and a matrix of controls throughout the manufacturing process to assure consistency, quality, and safety of the marketed product for human use. One major area of concern is virus safety. Through the combination of: (A) careful selection of raw materials; (B) testing of process intermediates; and (C) virus clearance evaluations of the individual steps in the manufacturing process; biologics manufacturers can demonstrate that their products are free from detectable adventitious and endogenous viruses. Comprehensive regulatory guidance suggests approaches for virus testing of biologics at early and later stages of clinical development and, although some countries have specific requirements, many of these approaches are harmonized worldwide. In general, regulatory authorities expect purification processes to include multiple steps with complementary, or orthogonal, methods for virus reduction including inactivation and separation or removal. Each step in the process may be more or less effective for reducing levels of different test viruses, and therefore selection of the appropriate panel of test viruses for the specific product is critical for viral clearance studies…

Biologics Production

biologics biopharmaceuticals cell culture mammalian cell culture raw materials purity viral clearance viral safety testing virus safety

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

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…

Analytics Biologics Production

adsorption photometry apbt cell culture cell culture fermentation mammalian cell culture matabolic analysers mbt membrane-based technology metabolicsensing technologies

Use of Interactive Laser-Scanning Imaging Cytometry (ILIC) for Real-Time Cytotoxicity Assessment of Bacteriocins Against Cultured Mammalian Cells

The evaluation of bacteriocin cytotoxicity is a critical first step in guaranteeing its safe use in food and therapeutic applications. In this study, the bacteriocins nisin, pediocin, and colicin ([Col] E1, E3, E6, E7, and K) were evaluated for cytotoxicity against cultured mammalian cells. Cellular membrane potential (delta psi) changes of bacteriocin-treated cells were used as an index of cytotoxicity. Simian virus 40-transfected human colon (SV40-HC) cells and African green monkey kidney epithelial cells (Vero) cells were cultured (35°C, 10% CO2, humidified air) as monolayers on tissue culture plates. Log phase cells (~104 cells/mL) were treated with partially purified, individual bacteriocin preparations at 170, 350, and 700 activity units (AU)/mL…

Analytics Biologics Production

analytics bacteriocin cytotoxicity bacteriocins biologics production colicin cytometry cytotoxic events ILIC interactive laser cytometry mammalian cell culture pediocin SV40 Vero cells

The Use of Signal Filtering Algorithms in Bioreactor Characterisation and Monitoring Using Raman Spectroscopy

Raman spectroscopy offers an attractive solution for monitoring key process parameters and predictive modelling in cell culture processes using transgenic Chinese hamster ovary (CHO) cells. Frequent in-line measurements offer the potential for advanced control strategies. However, an erroneous value created by analytical signal noise is a significant issue that can affect process controls negatively. One such challenge is to differentiate the signal reflecting process changes, ranging from random to gross error, in a timely manner so the process control system can respond to these changes and maintain adequate control.

Analytics Biologics Biologics Production Pre-Clinical Development Research

cho cells mammalian cell culture raman spectroscopy signal filtering algorithm

Evaluation of a Single-Use Benchtop Process Development System to Optimize Cell Growth and Scale-Up of Veterinary Vaccine Production

In the past 20 years, mammalian cell lines have been utilized to produce many viral veterinary vaccines. Cell lines such as baby hamster kidney (BHK)-21, Vero, and Madin Darby canine kidney (MDCK) are widely used because they help facilitate shorter manufacturing lead times and tighter process controls. As compared to other biotech products, viral vaccine manufacturing processes present some specific constraints linked to the cell substrates used. With the global veterinary vaccine market value predicted to be almost $7 billion per year by 2021[2], to remain competitively priced as well as profitable, bioprocess scientists are under pressure to develop methods for faster and more cost-efficient cell culture production. This has led to a shift from the use of expensive, two-dimensional T-flask and roller bottles to single-use, stirred tank bioreactors with microcarriers, or the adaptation of attachment-dependent cell lines such as BHK-21 for suspension culture. This requires time-consuming optimization and scale-up development experiments, which are real drawbacks. However, utilizing automated, single-use mini bioreactors as a scale-down model can enable more efficient use of time and optimization of media, feed, and culture conditions to de-risk upstream process development. In this article, single-use, mini bioreactors are evaluated to determine if they are geometrically comparable to benchtop bioreactors (both glass and single-use vessels) and pilot-scale, single-use bioreactors for effectively modelling mammalian cell culture at 2 L and 50 L scale…

Biologics Production

automation mammalian cell culture process development scale-up single-use bioreactor vaccines veterinary

Engineering MVM Resistance in CHO Cells

For decades, Chinese hamster ovary (CHO) cells have proven to be indispensable for the biopharmaceutical manufacturing industry, serving as cell factories that reliably produce grams per liter of recombinant proteins with the appropriate post-translational modifications and protein folding. However, one of the challenges of working with mammalian cells is that they are susceptible to viral contamination. Although the adoption of a wide range of risk mitigation strategies has made viral contamination a rare event, staggering costs and a shortage of life-saving medicines can result when these prevention strategies do fail, as demonstrated by a number of high-profile contamination events within the industry…

Manufacturing Risk Analysis and Management

contaminant control gene editing mammalian cell culture mammalian cell line development viral contamination

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