Manufacturing – Page 2 – 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

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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

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

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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

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Development and Assessment of a Novel Device for the Controlled, Dry Thawing of Cryopreserved Cell Products

While playing an integral role in biotechnology and medicine, cryopreservation (CP) is often viewed as a “simple tool” and is overlooked as a critical and evolving component of cell and tissue bioprocessing. Despite this, cryopreservation serves as an enabling technology in numerous areas including the latest cell therapies. For example, over one third of the cells used in clinical trials are cryopreserved using the traditional methods, which in many cases yield suboptimal outcomes. Further, researchers still rely on the assessment of cell survival immediately post-thaw (within a few hours), and fail to account for the impact of cryopreservation-induced delayed-onset cell death (CIDOCD) which continues to impact survival from hours to days post-thaw.

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

biodefense cell recovery cell repopulation cell research cell therapy cell viability cellular preservation cellular products cp cryopreservation cryothawing dmso dry thawing gene therapy high-throughput screening research science smartthaw stem cells water bath thawing

Fetal Bovine Serum: Risk Management

Safety is typically viewed, perhaps unconsciously, as the result of a collection of factors, conditions, or behaviors. For example, consider “safety” in the context of personal, financial, or travel. With each, safety is defined as a set of component risks that have been managed to satisfactory levels for a particular situation. The same is true for product safety and risk, whether it be for raw materials or finished goods. The “safe” use of fetal bovine serum (FBS) is achieved by the management of controllable risks to a level that is acceptable for each particular application. For example, risk reduction requirements for research applications are not as stringent as for diagnostic, therapeutic, or manufacturing applications. Each end-user must decide on the level of risk reduction that is appropriate for their application…

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Serum: What, When, and Where?

For over 80 years, fetal bovine serum (FBS) and other animal-derived materials have been widely used in the production of vaccines, and more recently, biotherapeutics, for both human and animal applications. Ever since FBS was initially developed as a cell culture reagent, there have been efforts made to avoid the use of this critical commodity. The International Serum Industry Association (ISIA) recognizes the requirement for robust risk assessment and management, and has several ongoing programs designed to help mitigate the risk of using animal-derived materials. This article will provide an outline of the state of the industry and of these programs…

animal sera animal-derived materials biologics raw materials biotherapeutics cell culture fbs fetal bovine serum isia serum traceability vaccines

Using Lifecycle and Quality by Design (QbD) Approaches to Define, Plan, and Execute Biopharmaceutical Projects

The world in general, and biopharmaceuticals in particular, are becoming increasingly complex and challenging. The ability to plan and execute a project to efficiently and effectively achieve a high-quality project goal is especially important for developing and manufacturing biopharmaceutical products. Managing projects ranging from product development, process characterization and validation, to building new manufacturing facilities requires straightforward, effective project management approaches and tools. But perhaps even more importantly, managing a project is a fundamental enabling skill required to manage both oneself as well as teams of people.

biologics enterprise biopharmaceuticals product lifecycle project lifecycle qbd quality by design sme subject matter enterprise

Operator Safety in Biopharmaceutical Manufacturing: The Role Raw Material Suppliers Can Play in Contributing to a Safer Production Environment

The proper handling of commonly used chemicals in bioprocessing is critical to maintaining a safe working environment as well as operational efficiency. Chemical mishandling can lead to failed batch processes, quality issues, as well as lost time and resources. As new technologies designed to help mitigate these safety risks become available, biomanufacturers have more opportunities to ensure that their production environments are safe. As a raw materials supplier, MilliporeSigma believes suppliers can play a critical role in terms of providing product and packaging solutions designed to minimize chemical handling risks…

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Category: <span>Manufacturing</span>