BioProcessing Journal

Long-Term CB.Hep-1 Monoclonal Antibody Production in a Single-Use Bioreactor on a Rocker Platform with Serum- and Protein-Free Media

Rocker bag bioreactors have been used successfully in cultivating cells because they provide good nutrient distribution and cell suspension while eliminating the need to validate cleaning and sterilization. Therefore, this study examined the long-term performance of a 50 L single-use bag bioreactor on a rocking platform in CB.Hep-1 monoclonal antibody (mAb) production. For such a purpose, the bioreactor was operated in a continuous mode with a mixture of serum-free media (SFM) for 62 days, and with protein-free medium (PFM) for another 62 days…

Biologics Biologics Production Bioreactor Scale-Up Research

applikon cb.hep-1 hbsag hep b vaccine hepatitis b mab monoclonal antibody protein-free media rocker platform serum-free media single-use bioreactor stationary phase culture

Direct, Real-Time Antibody-Based Quantification of Baculovirus

The impact of viruses—in geopolitical human health issues, in the production of vaccines and recombinant proteins, and in gene therapy and cancer treatments—highlights the need for a better understanding of the systems that are dependent upon them. A primary barrier to recognizing the full potential of these life-saving biomedical approaches is the scarcity of analytical methods capable of providing biologically relevant information without hindering the pace of development and production. ViroCyt® is a Colorado-based biotechnology company with one overriding focus: Enabling the rapid and specific quantification of viruses and virus-related particles. The ViroCyt Virus Counter® was designed to meet this objective.

Baculovirus Expression Technology Biologics Production Process Automation Research

antibody labeling bacmam baculovirus gene transfer mammalian cells nucleic acids quantification of baculovirus vaccines virocyt

Biopharmaceutical Manufacturing: Current Titers and Yields in Commercial-Scale Microbial Bioprocessing

This article reports the average titers and yields currently attained with commercially manufactured biopharmaceuticals expressed by microbial systems such as E. coli and yeasts. A recent BioProcessing Journal article comparably covered results from the first phase of this study concerning historical titers and yields attained for commercial-scale biopharmaceutical production using mammalian cells (e.g., CHO). As with this prior mammalian component, public domain data concerning titers and yields attained with microbially manufactured products were obtained using all available sources.

Biologics Production Bioreactor Scale-Up Mammalian Cell Culture Manufacturing Research

bacteria biopharmaceutical manufacturing mabs microbial bioprocessing microbial expression monoclonal antibody titers and yields yeast

Influence of Cell Disruption Methods on the Recovery and Immunogenicity of a Fusion Protein for a Therapeutic Cancer Vaccine Against HPV

Two cell disruption methods, mechanical and chemical, were applied for the recovery of a fusion protein named CIGB 550-E7, expressed on Escherichia coli grown in defined saline media. A comparison of the methods was done, and various operating parameters for each technique were optimized to obtain the maximum disruption efficiency and CIGB 550-E7 protein release. The mechanical disruption’s yield and recovery were 1.24 and 1.37 times higher than those obtained with chemical disruption. Modified conditions were assayed for the CIGB 550-E7 obtained by chemically defined media using the mechanical and chemical cell disruption methods.

Biologics Biologics Production Manufacturing Research

cell disruption cervical cancer e coli fusion proteins hpv hpv vaccine human papilloma virus immunogenicity purification

Improving Biopharmaceutical Manufacturing Yield Using Neural Network Classification

Traditionally, the Six Sigma framework has underpinned quality improvement and assurance in biopharmaceutical manufacturing process management. This paper proposes a neural network (NN) approach to vaccine yield classification and compares it to an existing multiple linear regression approach. As part of the Six Sigma process, this paper shows how a data mining framework can be used to extract further value and insight from the data gathered during the manufacturing process, and how insights into yield classification can be used in the quality improvement process.

Bioinformatics Biologics Biologics Production Research

bioreactor crisp data mining design-of-experiments dm methodologies doe FDA machine learning mvda neural network nn pat pneumococcal vaccine process analytical technology six sigma vaccine yield classification who

Signaling Substances Used in Plant Defense: HPLC-MS/MS Analysis of Jasmonates

Plants must be capable of responding to climatic fluctuations, diurnal rhythms, available supplies of water and nutrients, and insect attacks and infestations. To ensure such responses, plants need a network of regulating substances called phytohormones. These substances enable plants to respond to both biotic and abiotic stresses by initiating a cascade of orchestrated actions, and to trigger development-specific processes. In this article, we will discuss a highly sensitive analytical method for quantitative determination of phytohormones. The main representatives of the plant hormones are jasmonic acid (JA), cytokines, auxins, abscisic acid, salicylic acid, gibberellins, and strigolactones.

Biologics Research

HPLC hplc-ms mass spectrometry nanoESI-MS plant signaling sartorius ultrapure water

Development of a Novel Flow Cytometry-Based Titration Assay to Quantify Herpes Simplex Virus Type 1 (HSV-1)

Plaque assays have traditionally been a reliable way to determine the titer of a lytic virus. However, this method has several shortcomings in that it is time-consuming, labor intensive, and suffers from limited sensitivity. In this article, we describe a novel flow cytometry-based titration assay to quantify green fluorescent protein-labeled herpes simplex virus type 1 (HSV-1-GFP). Using this assay, we were able to directly quantify ten-fold dilutions of the virus in which every GFP-positive cell could be counted. In a head-to-head comparison with a traditional plaque assay, the flow cytometry assay showed a greater linear range and was accomplished in less than half the time of the plaque assay.

Bioinformatics Biologics Biologics Production Regulatory Research

flow cytometry gfp green-fluorescent protein herpes simplex 1 hsv-2 plaque assay titration assay virus

Antibody-Dependent Cellular Phagocytosis: The Mechanism of Action That Gets No Respect A Discussion About Improving Bioassay Reproducibility

Antibody-dependent cellular phagocytosis (ADCP), which relies on macrophages to attack and devour tumor cells following antibody binding, is a potentially useful mechanism of action (MOA) for antibody drug developers and vaccine makers to consider in determining product efficacy. Unfortunately, it is often ignored in favor of more accessible MOAs driving biological function such as antibody-dependent cellular cytotoxicity (ADCC) because the assays are tedious to prepare, perform, and reproduce.

Biologics Biologics Production Regulatory

adcc antibody-dependent cellular cytotoxicity bioassays ind investigational new drug mab mechanism of action moa monoclonal antibody ph eur USP

The Contamination Triangle: A New Model for Assessing the Risk of Biological Process Contamination and Performing Investigations

Microbial contamination is of great concern in pharmaceutical and biotech manufacturing. Many organizations struggle with determining the root cause of contamination when it occurs, and identifying effective safeguards to prevent future contaminations. This article will introduce a new model for understanding microbial contamination in biopharmaceutical and sterile products and processes. The “Contamination Triangle” identifies the three factors necessary for microbial ingress into a sterile (or pure) system. The use of this model will provide guidance for contamination investigations, clarify the explanation of the contributing root causes in Non-Conformances, and assist in identifying risks and risk mitigation measures as part of a Failure Modes and Effects Analysis (FMEA) or other risk assessment method…

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Fed-Batch Bioreactor Process Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

biological contamination biopharmaceuticals biotech manufacturing contamination mitigation contamination triangle fmea microbial contamination microgial ingress risk assessment sterile processes sterile products

Regulatory and Monetary Drivers for Real-Time Analytics

Implementation of “real-time” analytics (RTA) in processes for biologics is challenging from a technological and timeline perspective. Therefore, there need to be significant drivers from both a regulatory (quality) and a monetary standpoint to justify investment. Understanding how regulatory agencies define real-time analytics and the expectations for implementations (how and when) is a key component to rational decision-making, and dovetailing process improvement and facility design is important in the planning and development process…

Biologics Production Cell & Gene Therapy Cell Lines Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

at-line analytics biolgics design space biologics cpp critical process parameters design-of-experiments doe fda guidance fmea in-line analytics ind investigational new drug mabs monoclonal antibodies on-line analytics pat process analytical technology real-time analytics regulatory considerations rta

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