Current Status of Analytical Techniques for Characterization of Protein Stability

Posted on July 20, 2018

Abstract A major goal of pharmaceutical development is to characterize pathways of chemical and physical instability and develop strategies to minimize them. The potential for the presence of multiple degradation products in protein-based pharmaceuticals highlights a need for analytical methods capable of reliably and accurately identifying and measuring those variants. Our review aims to provide […]

Continue Reading

Single-Use-Systems: Leachable Study Design for Single-Use Components

Posted on July 20, 2018

Biopharmaceutical manufacturers can realize substantial gains in process flexibility, speed, and efficiency through implementation of polymeric single-use systems (SUS) for use in their manufacturing processes. The use of polymeric single-use-systems (SUS) and components has increased dramatically in biopharmaceutical manufacturing processes. SUS are comprised of polymers, and the manufacturing process for the SUS can utilize a […]

Continue Reading

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Posted on July 20, 2018

The production of biopharmaceutical products relies on the successful execution of complex production tasks. Multiple factors ranging from availability of raw materials and trained personnel to adequate facilities are essential. However, without a systematic and well-orchestrated business process and adequate tools, biomanufacturers risk down-time, costly deviations, and, most significantly, potential loss of product. One aspect […]

Continue Reading

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

Posted on July 13, 2018

James Barry, Director of Marketing, Americas Since disposable technologies have demonstrated their numerous benefits and reliability at the development and clinical scales, biopharmaceutical manufacturers are slowly increasing the implementation of single-use systems for commercial-scale manufacturing in upstream, downstream and fill/finish operations. In response to changing customer needs, Pall Biotech has expanded its established and widely […]

Continue Reading

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Posted on July 13, 2018

Introduction Control of bacterial endotoxins, gram-negative bacteria that can cause pyrogenicity, is critical in the manufacture of pharmaceutical drug products intended for parenteral administration. Unlike bioburden, which can be readily eliminated by terminal sterilization via autoclave or filtration through a 0.22 µm membrane during aseptic filling, bacterial endotoxin is difficult to remove during routine manufacturing […]

Continue Reading

Accelerating the Commercialization of Biosimilar Medicines in India

Posted on July 10, 2018

SSB’s forum discussed the latest developments in bioprocessing and biosimilar development There is a flourishing biosimilar medicine industry in India focussed on the supply of affordable biologics to the domestic market. Regulators in India have already approved over 50 biosimilar drugs. Companies such as Dr Reddy’s, Biocon and Intas Biopharmaceuticals are internationally recognised brands and […]

Continue Reading

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

Posted on July 10, 2018

Protein A chromatography is widely used as the affinity capture step of both mAbs and Fc-fusion proteins because of its high degree of selectivity. Variations in elution behavior of the protein A capture step require more process development work and could have an impact on the polishing step in the downstream process. Thus, minimizing the variation in elution pH between […]

Continue Reading

Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)

Posted on June 13, 2018

Gene therapy, including oncolytic viruses, where new genetic material is introduced into the body, holds promise to cure or alleviate symptoms of many different diseases. In the last few years, the field has seen rapid growth with at least 11 drugs approved globally. A ClinicalTrials.gov search on the term ‘gene therapy’ returns 734 industry sponsored […]

Continue Reading

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Posted on June 8, 2018

Monica Cardona and Ian Johnson Purpose The Water Intrusion Test is widely used in the pharmaceutical industry to test the integrity of tank, autoclave and lyophilizer vent filters. The purpose of this document is to present the collected best methods/practices to give filter end users the best possible chance of performing a successful WIT. It […]

Continue Reading

Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification

Posted on June 8, 2018

  John Amara, Ph.D. and Michael Dullen Abstract Recent advancements in the productivity of upstream cell culture processes for the manufacture of therapeutic proteins, including monoclonal antibodies (mAbs), have resulted in greatly elevated cell densities and higher levels of process-related impurities. Current depth filters may demonstrate an insufficient filtration capacity for these applications and often […]

Continue Reading

Changing Column Packing from an Art into a Science

Posted on May 11, 2018

Chromatography is often the most critical step in biopharmaceutical downstream processing because of its role as the engine for separating impurities from target biologics. The most demanding operation in production scale chromatography is typically packing the column in a way that ensures first time success and a validation result which meets the batch record standards. […]

Continue Reading

Process Analytical Technology For Upstream Bioprocessing

Posted on May 4, 2018

In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence (COE) […]

Continue Reading

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

Posted on April 25, 2018

The Cadence inline diafiltration (ILDF) device is designed for continuous processing, in-process buffer exchange or contaminant removal in various processes in a wide range of applications in the biopharmaceutical industry. This includes buffer exchange for final drug substance, desalting or buffer exchange before or after column chromatography, and small molecule contaminant removal. The single pump pass […]

Continue Reading

Enabling Total Biopharma Solutions

Posted on December 12, 2017

After a few decades of speculation and proof of concept, the biopharmaceutical industry has fully embraced the advantages of single-use technologies throughout all phases of drug production1. In particular, as industry interest shifts to continuous bioprocessing versus traditional batch methods, the flexibility of single-use technologies has once again emerged as an asset to industry advancement. […]

Continue Reading

Coupling single-pass TFF before loading onto a chromatography sorbent

Posted on September 28, 2017

Process and economic benefits could be achieved by coupling single-pass tangential-flow filtration (SPTFF) and chromatography steps at manufacturing scale. This results in significant sorbent/buffer cost savings and/or reduced processing times. Additionally, the reduced volumes will also help to downsize all future unit operations. As a result, smaller equipment, tank sizes, and hold-up volumes will reduce […]

Continue Reading

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

Posted on August 22, 2017

Protein A affinity chromatography represents the key initial capture method in monoclonal antibody (mAb) purification. There are three major types of protein A “resin” based on a different matrix chemistries – glass, agarose and synthetic polymer. State of the art resins must offer good specificity, high mass transfer and binding capacity, low non-specific adsorption, low ligand leakage, suitable back pressure […]

Continue Reading

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Posted on March 17, 2017

Summary Single-pass tangential flow filtration (SPTFF) followed by multi-column chromatography (MCC) was used to continuously process a cell culture supernatant containing a monoclonal antibody (MAb) via Protein A affinity chromatography. This study demonstrates the benefit of such a combination in term of process robustness, productivity and economics of continuous processing. The SPTFF technique can readily […]

Continue Reading