Trends in Single-Use Mixing Technologies and Insight into Pall and Lonza Ibex® Solutions
Posted on December 7, 2021
Single-use bioprocessing has rapidly become the industry standard, triggered by the pandemic and the array of vaccines coming to market. These growing demands have pushed biomanufacturing facilities to increase production by becoming more modular and scalable. Single-use mixing systems, a key part of any bioprocess, also need to offer flexibility to help manufacturing plants achieve […]
Continue ReadingOvercoming Obstacles in AAV Viral Vector Manufacturing
Posted on September 19, 2021
Rapidly growing interest in gene therapy has led to the need for more cost-effective and scalable viral-vector manufacturing platforms. Adeno-associated virus (AAV) has become a vector of choice because of its safety profile (nonpathogenic infection). In addition, AAV cannot replicate on its own and is not integrated directly into the host genome. AAV manufacturing using […]
Continue ReadingBringing the Freezing of Biopharmaceuticals in From the Cold
Posted on March 15, 2021
59.4% of manufactured biopharmaceuticals are shipped in a frozen state. Add to this the COVID-19 response requiring a truly global manufacturing supply chain where frozen storage and transport of drug substance between bulk fill and final fill is commonplace, and there’s never been a greater need to understand this critical step in the manufacturing process. […]
Continue ReadingNavigating Technology Transfer
Posted on June 26, 2020
Technology transfer is a key milestone in the journey from discovery to full-scale GMP-compliant manufacturing. Pall’s combined knowledge and understanding of the processes, and technological capabilities will help you navigate through the challenges of your tech transfer reducing your costs, resources and time. Download the BPI article, Navigating Technology Transfer here to learn how partnering […]
Continue ReadingA SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor
Posted on May 25, 2020
Establishing a platform for developing and manufacturing therapeutic proteins will eliminate the bottleneck between cell-line development and tech transfer. The Celltheon SMARTTM Technology Platform in combination with Pall Biotech’s manufacturing equipment accelerates time from cDNA to pilot scale with a pre-defined fed-batch and downstream processing platform for monoclonal antibodies and difficult to express therapeutic proteins. […]
Continue ReadingCharacterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor
Posted on May 13, 2020
Stirred tank bioreactors (STRs) have become a popular choice for single-use large scale commercial manufacture of suspension cell lines and therapeutics. Cell culture performance is strongly influenced by the efficiency of mixing to achieve culture homogeneity, supplemented with the effectiveness of gas delivery to support varying oxygen mass transfer coefficient (kLa, O2) demands. The ability […]
Continue ReadingSuccessful Wetting for Filter Integrity Testing in Volume-Restricted Systems
Posted on February 10, 2020
Filters with a qualified retention for bacteria, mycoplasma or viruses are commonly used in many pharmaceutical processes. In a validated GMP process, these filters must be routinely tested for integrity. The automated test instruments used for filter integrity testing have a very sensitive measurement system and are capable of detecting almost all conditions, where external […]
Continue ReadingBenefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification
Posted on April 2, 2019
This note addresses the performance of Pall’s mixed-mode cation exchange (CEX) CMM HyperCel sorbent, which can be applied to both monoclonal antibody (mAb) polishing and recombinant protein purification. The study highlights the behavior of the CMM HyperCel sorbent versus conventional cation exchange (sulfopropyl groups) and a weak cation exchange multi-modal sorbent (cross-linked agarose) in terms […]
Continue ReadingVolume Reduction and Process Optimization with Cadence Inline Concentrator
Posted on March 26, 2019
Traditional tangential flow filtration (TFF) is one of the most widely used technologies in downstream bioprocessing. It can be used for concentration or diafiltration and has traditionally been operated in batch mode. Operating in batch mode has some disadvantages in terms of overall process economics, for example large volumes of process fluid must be handled […]
Continue ReadingCurrent Status of Analytical Techniques for Characterization of Protein Stability
Posted on July 20, 2018
By Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning 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 […]
Continue ReadingSingle-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 ReadingScheduling 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 ReadingExpanding 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 ReadingEndotoxin 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 ReadingAccelerating 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 rewrite business brands […]
Continue ReadingAmsphere 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 ReadingChoice 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 ReadingBest 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 ReadingNovel 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 ReadingChanging 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 request college essay help link time success and a validation result which […]
Continue ReadingProcess 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 ReadingCleanability 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 ReadingEnabling 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 ReadingCoupling 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 ReadingComparison 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 ReadingContinuous processing optimization with smarter tools
Posted on June 30, 2017
Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them. As orphan drugs and personalized medicine begin to replace traditional blockbuster products, pharmaceutical companies are looking at new and innovative career success from re grammar […]
Continue ReadingContinuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release
Posted on April 11, 2017
Summary Continuous bioprocessing offers potential to enhance productivity and product quality uniformity while simultaneously decreasing facility footprint and associated operational overhead. Advances in technology and increasing commercial pressures are leading to an increased interest in continuous processing across the biopharmaceutical sector. A number of companies are exploring and advancing continuous bioprocessing and this presents a […]
Continue ReadingProductivity 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 […]
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