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Evaluating AMMP Protein A Assays: Comparing Sample Preparation Methods, Ligand Performance & Assay Performance

Regulations governing the production of biopharmaceuticals require high levels of purity for processes utilizing Protein A affinity chromatography. It has been shown that Protein A in the presence of IgG forms a PA/IgG complex that interferes in the traditional immunoassay format for detecting Protein A. In this work we evaluated the AMMP Protein A Assay using two popular sample preparation methods to dissociate the ProteinA/IgG complex. The AMMP assay was also tested with Protein A ligands from multiple sources including…

A Single-Use Bioreactor for Both Cell and Microbial Cultures: A Dream Becomes Reality

Application of single-use equipment is common practice in the biopharmaceutical industrial and academic field. Compared to the traditional glass or stainless steel bioreactors, single-use bioreactors offer clear advantages: a quicker turnaround time; minimal utilities required; greatly reduced risk of cross contamination; more operational flexibility; reduced validation requirements. However, until recently, single-use bioreactors have a restricted application, only to animal cell cultures due to limitations in mixing and mass-transfer. As single-use technology not only has significant benefits for cell culture processes,…

Effect of process condition on the Mycoplasma rentention of cell culture media filtersMethods

A Mycoplasma contamination event can have a major impact on a biopharmaceutical manufacturer. The loss of a cell culture due to a contamination incurs significant costs that can be attributed to both the initial bioreactor set-up and to the subsequent decontamination. Production facility throughput may be affected and in the worst cases the ability of the manufacturer to supply patients with medicines. Mycoplasma are extremely small in size and lack a cell wall giving the cells some flexibility that enables…

Salt-tolerant cation exchanger for direct capture of proteins

Ion-exchange chromatography is widely used for the purification of biotherapeutic proteins. Usually, cation exchangers are applied in the primary capture step of proteins with alkaline pI. Conventional ion-exchange chromatography has the advantage of high-binding capacity, but it requires low salt conditions for protein binding and consequently adjustment of conductivity of clarified culture supernatant. An alternative method to maintain some binding capacity at higher conductivity levels is working at low pH condi¬tions notwithstanding that some proteins are sensitive to acid treatment.…

Protein A Cellulose, a new mAb purification platform

Protein A chromatography is widely used as capture step in monoclonal antibody purification processes. Many types of chromatographic media are commercially available for this application however mainly Agarose and Porous glass based products are considered as standard mAb purification platforms due to high dBC and high operational flow rates. In fact process optimization of Protein A step is mainly aimed to have higher capacity and lower elution volumes in shorter process time. In this context Kaneka has been investigating highly…

Lipid Removal by Depth Filters in Plasma Fractionation

We herein describe a 3M Purification Inc. depth filter media – Zeta PlusTM DELI that exhibits selective adsorptive properties for plasma lipids. Lipids plug chromatographic columns and filters during plasma fractionation steps and cause solution instability for the final product. Several parameters which could affect the lipid removal efficiency on Zeta Plus DELI have been investigated: prefiltration, contact time, ionic strength, pH, and temperature. The maximum percentage of total lipids eliminated, in optimal operating conditions, was 68%. This method has…

Intensified Manufacturing: Economic Models Comparing Steel, Single-Use and Concentrated Process Options

Refine Technology, LLC, in conjunction with Biopharm Services, developed two economic models to examine the cost of goods and capital requirements of cell culture production facilities configured based on different production scenarios, including variables such as:

• Amount of product required
• Vessel sizes
• Number and type of vessels (stainless steel vs. single use)
• Product titer
• Seed train
• Upstream and downstream requirements

In this educational webcast, John Bonham-Carter, Vice President of Sales and Business Development at Refine Technology, analyzes the effect of these variables in relation to operating mode, continuous culture (perfusion) versus traditional fed batch. Join John as he presents results and discussion for facilities producing 50 and 500Kg of protein per year.

Meeting Increased Demands on Cell-Based Processes By Using Defined Media Supplements

As the demand for cell-derived products is rapidly increasing, there are huge pressures on the biomanufacturing industry’s production capacity requirements. To keep up with this demand, more focus is being put into media development strategies for optimizing output from cell culture systems. Serum-based media have traditionally been used to address the individual nutrient requirements of animal cells used in manufacturing protein products, but are now being gradually phased out due to inconsistencies and potential contamination risk.

These factors have created a demand for development of serum-free media that deliver optimal cell growth and productivity. This white paper looks at the challenges facing biopharmaceutical manufacturers today and the role of defined media supplements in addressing those.

Streamlining Downstream Process Development

Normal-flow filtration is used throughout downstream processes for biologics including depth, sterile, and viral filtration applications. Because of its ubiquity in large-scale biomanufacturing, using the most efficient normal-flow filter media area and type can lead to significant cost savings. But determining the most effective media type and area can be time consuming, labor intensive, and complicated because of a lack of specialized laboratory-scale equipment.

The equipment commonly used in this evaluation presents several disadvantages, including poor integration of multiple components from different sources (including pressure sensors, signal conditioning, data acquisition, balances, and pumps), continuous operator monitoring, and decreased portability of most systems due to their numerous components. This white paper describes how Genentech Inc. and PendoTECH collaborated on developing an integrated filter-sizing system that addresses these challenges and aids in efficient evaluation of filter media for manufacturing-scale processes.

Navigating the Biopharmaceutical Regulatory Pathway: Replacing Undefined Raw Materials with Chemically-defined Substitutes

With market demands increasing, biopharmaceutical producers are constantly looking for ways to enhance product quality while reducing costs and risk. One way to meet these changing demands is to replace animal-derived supplements with chemically-defined substitutes. In this educational webcast, Dr. Michael Titus, Director of Quality Management and Regulatory Compliance with BD Biosciences, outlines the regulatory pathway involved in making such a switch. Dr. Titus will discuss:

• A background on the uses of supplements in the cell culture production process;
• Change control & risk management;
• And the regulatory path of making the switch to chemically-defined supplements.

Join Dr. Titus as he demonstrates how chemically-defined supplements can boost performance, reduce risk and increase consistency in commercially marketed biopharmaceutical products.