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By Anna Rose Welch, editor, Biosimilar Development

In the first part of this two-part article, I picked two Sandoz executives' brains about the progress they�ve observed and how challenges for the industry have evolved over the past 10 years.

By John Serio, Burns & Levinson

Over the past decade, patent reform has been an area of emphasis for Congress. This article explores several of the main tenets of the STRONGER legislation, which biologics and biosimilar makers should be aware of as the Inter Partes Review (IPR) currently remains a critical part of patent litigation today.

This is the first installment in a three-part series that examines what causes protein aggregation and practical steps you can take to mitigate the risk.

Real-time quantitative PCR (qPCR) is a powerful and commonly used method for quantifying gene expression. It is an accessible technology that can be quickly learned. However, by keeping a few key steps in mind as you plan and run your real-time PCR (polymerase chain reaction) experiments you can optimize your qPCR experiments and ensure high-quality data and reproducible results.

This white paper discusses the importance of understanding how critical process parameters can impact a product�s critical quality attributes and how a systematic approach with validated SPR (surface plasmon resonance) assays can help in this respect.

GE Healthcare Life Sciences

By Anna Rose Welch, editor, Biosimilar Development

Following the news of Fresenius Kabi�s new biosimilar R&D lab, I reached out to one executive to discuss the current challenges in biosimilar R&D, including maintaining the delicate balance between biosimilar R&D and commercial teams as Fresenius Kabi prepares for a long future in the biosimilar space.

By P. Chen, F. Eyzaguirre, T. Francis, and J. Shmuel, Fish & Richardson

This is the second article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding BPCIA district court litigation and reviewed ongoing district court cases. In Part 2, we turn our attention to BPCIA district court cases that were settled in 2019.

By Michael Song, Ph.D.

ISO 10993-1 is typically the starting point for biocompatibility study planning as it provides a general overview and recommendation on testing endpoints. While this may seem straightforward, there are a number of intricacies when conducting biocompatibility studies.

Need to find out how to calibrate your size exclusion chromatography (SEC) column, or how different additives affect your results? Read these useful insights.

Bio-Rad Laboratories, Inc.

By Anna Rose Welch, editor, Biosimilar Development

In the first part of this two-part article, I picked two Sandoz executives' brains about the progress they�ve observed and how challenges for the industry have evolved over the past 10 years.

By John Serio, Burns & Levinson

Over the past decade, patent reform has been an area of emphasis for Congress. This article explores several of the main tenets of the STRONGER legislation, which biologics and biosimilar makers should be aware of as the Inter Partes Review (IPR) currently remains a critical part of patent litigation today.

This is the first installment in a three-part series that examines what causes protein aggregation and practical steps you can take to mitigate the risk.

Real-time quantitative PCR (qPCR) is a powerful and commonly used method for quantifying gene expression. It is an accessible technology that can be quickly learned. However, by keeping a few key steps in mind as you plan and run your real-time PCR (polymerase chain reaction) experiments you can optimize your qPCR experiments and ensure high-quality data and reproducible results.

This white paper discusses the importance of understanding how critical process parameters can impact a product�s critical quality attributes and how a systematic approach with validated SPR (surface plasmon resonance) assays can help in this respect.

GE Healthcare Life Sciences

By Jim DeLee, Fluid Components International

Engineers and technicians looking to optimize their processes for productive operation can start with the pump and protecting the pump against common hazards. Pump protection improves end product or batch quality, reduces material costs, eliminates waste, and lowers maintenance costs. Taking good care of your pump delivers a positive payback.

By MIDAC Corporation

A Fourier transform infrared spectrometer was built by MIDAC Corporation specifically to identify and quantify impurities in ultra-high purity nitrogen, helium, argon, and instrument air. 

Covestro had a wealth of data streaming in from equipment and processes; data that could theoretically be harnessed and acted upon. But its data was difficult to access, stored in local silos, and cut off from sharing and analysis by the lack of enterprisewide data standards. The fix for Covestro: making full use of its PI system.

Aerzen USA�s customer (plant operator) has a contract to operate an air separation plant supplying oxygen to a glass furnace at a lighting products company. By reducing or eliminating the introduction of inert nitrogen into the furnace, the oxygen-enhanced combustion technology increases production, decreases fuel consumption, and reduces emissions, while maintaining or even increasing product quality.

As gene transfer vehicles, lentiviruses exhibit many desirable properties, such as high transduction efficiencies, ability to infect both dividing and nondividing cells, and stable integration into the host cell genome. However, cost-effective manufacturing of lentiviral vectors at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy. Here, insights around the challenges in viral vector manufacturing are shared so that a scalable and cost-efficient process suitable for GMP manufacturing environments can be obtained.

Streamlining, connecting, and automating workflows to shape the future of cellular treatment delivery has the potential to transform how we treat and potentially cure once life-threatening diseases.

Manufacturing viral vector-based therapies, such as vaccines and gene and cell therapies, is complex, but a new manufacturing solution helps solve the challenges.

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By OSIsoft

With thousands of people killed following a gas leak at a pesticide plant in India, the Bhopal tragedy of 1984 is widely regarded as the world�s worst industrial disaster. More than three decades later, with all the advancements in safety technology, hazardous situations such as Bhopal should be a distant memory.

By Ralph Rio, Seeq Corporation

Emerging Industrial IoT (IIoT)-enabled condition monitoring and predictive maintenance approaches allow manufacturers to re-consider outsourcing to the OEM. Faced with the current skills shortage and other constraints, many will find OEM supplier-provided services appealing.

Whether you are upgrading to a more sophisticated system, replacing old software, or about to launch your first WMS, this buyer�s guide will provide straightforward advice on how to end up with the right solution.

This application note offers tips for efficiently containing powders in a ribbon blender to ensure operator safety, prevent cross-contamination and promote easy clean up.

The customer had no natural gas flow measurement for its standby generators and wanted to know how much gas each unit was using. The customer also wanted to know the performance efficiency of each generator to enable them to establish an effective maintenance schedule. 

Everybody knows that FTIRs can do the monitoring, and it usually gives the most coverage, but what�s the reason that somebody would spend more money on an FTIR unit when conventional instruments are cheaper?

By Anna Rose Welch, editor, Biosimilar Development

Sandoz's William Yoon and Sheila Frame reveal their expectations for the biosimilar industry, touching upon what education efforts are still needed and what trends in the broader pharmaceutical and healthcare market will be influential for future waves of biosimilar development and access.

By Kate Cook, Greenleaf Health

The Further Consolidated Appropriations Act, 2020, signed into law on December 20, 2019, contains three provisions with implications for transition products. This article will review each of these three provisions � and their potential impact on sponsors � in further detail.

Sometimes your size exclusion chromatography (SEC) results don�t look like you want them to. Fix issues such as poor resolution, peak tailing, and fronting with the tips in this FAQ.

Bio-Rad Laboratories, Inc.

By Anna Rose Welch, editor, Biosimilar Development

Sandoz's William Yoon and Sheila Frame reveal their expectations for the biosimilar industry, touching upon what education efforts are still needed and what trends in the broader pharmaceutical and healthcare market will be influential for future waves of biosimilar development and access.

By Kate Cook, Greenleaf Health

The Further Consolidated Appropriations Act, 2020, signed into law on December 20, 2019, contains three provisions with implications for transition products. This article will review each of these three provisions � and their potential impact on sponsors � in further detail.

Sometimes your size exclusion chromatography (SEC) results don�t look like you want them to. Fix issues such as poor resolution, peak tailing, and fronting with the tips in this FAQ.

Bio-Rad Laboratories, Inc.

The reliable supply of biological-based medicinal therapies is highly dependent on a robust, well-planned, and risk-managed supply chain. Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.

The need for a film constructed specifically to meet the complex bioprocessing nature of a multitude of biologics was great. Fortem film is purposefully designed and developed with a carefully selected raw material, incorporating advanced manufacturing technology with an overarching focus on transparency along the entire supply chain.

The challenge of designing a universal film requires a number of competing properties, and the functional requirements of every application must be balanced against one another. A number of considerations must be measured while doing so. These include choice of polymers, film thickness, flexural properties, degree of crystallinity, resistance to gas transmission, and many more.

As it stands, there are no current standards in place for the testing of single-use extractables and leachables (E&L). Organizations such as the Bio-Process Systems Alliance (BPSA) have adopted their own set of standards for E&L testing, though the need for a standard approach is clear � particularly where end users using single-use equipment as a manufacturing strategy are concerned.

By ABB Measurement & Analytics

Isolation seals protect transmitters while faithfully conveying pressure signals. They enhance the measurement of not only pressure and vacuum, but also of derived variables, including flow rate, level, and density. Because of their measurement flexibility, electronic differential pressure (DP) transmitters are widespread throughout industrial and municipal processes.

By Schenck Process LLC

Mixing is considered one of the essential processes in manufacturing, and there are many factors to consider before the purchase of a new mixer. Following is a guideline for the selection, specification, and purchase of Gardner mixing and processing equipment.

By utilizing small batch monitoring technology, Sartomer has real-time visibility into production runs, and in the control room, any person, new or experienced, can detect off-track batches and minor deviations as they occur.

The right ERP solution can significantly improve product costing, production predictability and scalability, as well as compliance issues related to traceability and MSDS. This guide will help you identify the right solution for your operational needs by focusing on what questions you�ll need to ask during the evaluation process.

Aerzen provides reliable, safe, and efficient blowers and compressors for steam applications. Rotary lobe blowers and screw compressors feature application-specific design of the package and the stage to meet desired MTBO targets and other site requirements.

Among solid-solid blending systems, the three most common types are the horizontal ribbon blender, the cone screw vertical blender, and the tumble blender. Aside from level of shear or gentleness, other factors help determine what type of blender will work most efficiently in a certain application. Here are some things to consider when choosing your blender.

A semicontinuous process is beneficial to maintaining a clean and streamlined batch mixing operation without compromising the level of control over discrete units of production. The semicontinuous mixing procedure is achieved by utilizing a change-can design mixer. With multiple vessels, one mix could be at the loading stage, another under the mixer, another at the discharge step, and yet another at the cleanup stage.

Mixing is an integral part of food, beverage, dairy, and pharmaceutical production. Within these industries, one of the most common specialty mixing systems in operation are multishaft mixers. This article discusses several equipment features commonly supplied on multishaft mixers intended for sanitary applications.

Many of the advantages of mixing, blending, and drying under vacuum have been recognized for years. But until recently, vacuum has also been widely misunderstood. Many processors have considered vacuum essential � and cost-effective � only for the most demanding applications.

The inability to uniformly disperse powders into a liquid batch within a practical amount of time is an all-too-common mixing problem that impacts productivity, labor costs, and power consumption. This article offers five tips for dispersing powders more efficiently.

Ultra-high-shear mixers can effectively replace costly high-pressure homogenization and colloid milling operations while delivering comparable levels of dispersion and particle size reduction. This article presents four advanced rotor/stator technologies for ultra-high-shear mixing of fine dispersions, emulsions, and other applications.

By Anna Rose Welch, editor, Biosimilar Development

Seeing as Sheldon has been in oncology care for almost 40 years and still works as an oncology nurse practitioner, she was the perfect person to speak to about the trends she�s observing in oncology care, in addition to the current role biosimilars play � and could still play � in oncology.

By P. Chen, F. Eyzaguirre, T. Francis, and J. Shmuel, Fish & Richardson

This is the third article in a four-part series on 2019 legal developments related to the biosimilar sector. Here, we review BPCIA Federal Circuit appeals that are pending and those that were recently decided.

By Barbara Unger, Unger Consulting Inc.

To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily digestible prose, to save you the spreadsheet struggle. 

Droplet digital polymerase chain reaction (ddPCR) enables easy multiplexing of numerous targets within each fluorescent channel. Amplitude-based multiplexing achieves this by varying primer and/or probe concentrations. In probe-mixing multiplexing, probes are mixed at desired concentrations to place targets in a defined position on a 2D plot. This paper describes strategies for both approaches using the large portfolio of ddPCR assays readily available through Bio Rad.

Achieving �smarter,� more flexible workflows requires a complete understanding of today�s novel solutions and technologies, which, when applied appropriately, can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry.

Pfizer CentreOne Contract Manufacturing

By Anna Rose Welch, editor, Biosimilar Development

This has been a very exciting time for those in drug discovery, while it's been a bit quieter on the biosimilar front (understandably). That said, there have been a few tidbits of knowledge here and there about the impact this pandemic may or may not yet be having on the biosimilar space.

By Jeremy Schafer, Precision for Value

Site of care strategies can generate cost savings, but they may also create unintended consequences as new controls disrupt the traditional dynamics of buy and bill. However, just as biosimilars have disrupted the status quo of the biologics market, they may also find opportunity in impacting how care is delivered.

Biosimilar expert Amanda Turner provides an overview of the factors that are important when considering which assays and antibodies to utilize in biosimilar development.

If you're using one of these six excuses for ignoring pharma market research, you're failing to understand barriers to success, missing the market's perspective, and leaving assumptions unvalidated.

Surface plasmon resonance (SPR) can be implemented at early stages in screening and testing strategies in order to provide better, faster, and stronger analysis of drug candidates. In order to minimize risk and to get "true" affinity in binding analysis, we have adopted the latest innovation in SPR technology, BiacoreT 8K, to develop and qualify assays for monoclonal antibodies and other therapeutic proteins to ensure all critical quality attributes are set and controlled with accuracy and precision.

By Anna Rose Welch, editor, Biosimilar Development

One oncology expert shares his thoughts on the operational challenges biosimilars may pose hospitals and what biosimilar manufacturers need to consider as they continue to invest in and launch oncology biosimilars.

By Kate Cook, Greenleaf Health

The FDA has prepared diligently for the transition date by issuing guidances addressing several sticky issues, including final Q&A guidance on the "deemed to be a license" provision of the BPCIA.

By Barbara Unger, Unger Consulting Inc.

Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

With all the promise biosimilars hold, why we are not seeing increased market uptake? There are many reasons that involve policy, legislation, and the legal system that have led to the current state of the biosimilar market in the U.S. This white paper examines the basics.

Flow cytometry introduces a powerful and versatile technology into studies, enabling in-depth analysis of cell signaling and behavior.

?KTA go is a small and compact liquid chromatography system that allows researchers to perform routine protein purification with ease while allowing for efficient use of bench and cold cabinet space.

Pfizer CentreOne Contract Manufacturing

By Anna Rose Welch, editor, Biosimilar Development

Though the IDN is a unique setting of care, there were still several lines of discussion that arose from Kaiser Permanente''s best practices that sparked discussion on how other stakeholders, particularly employers, can start to chip away at the systemic issues standing in biosimilars' way.

By Ben Locwin, Ph.D.

At the behest of Congress, an interagency Drug Shortage Task Force, led by the FDA, recently published the Drug Shortages: Root Causes and Potential Solutions report. Here, we unpack the four root causes for drug shortages as determined by the task force.

This is the first installment in a three-part series that examines what causes protein aggregation and practical steps you can take to mitigate the risk.

The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

Bio-Rad Laboratories, Inc.

By Christine Banaszek, Charles Ross and Son Company

In the processing world, safety management cannot be overemphasized. The mixing room, in particular, is a source of many potential health and operational hazards. Aside from typical engineered solutions and safety systems, there are some basic and practical ways for improving safety in the mixing area. Here are a few considerations that process engineers can apply to existing operations and during equipment procurement.

The MIDAC Air Monitoring Extended Range analyzer system was purpose built for fence-line monitoring. It sees utility in fugitive emissions monitoring, air quality analysis and leak detection.

A major oil/gas producer in the Southeastern U.S. needed to implement enhanced oil recovery (EOR) technology to boost production in a mature oil field. For the past 25 years the company had been using water-flooding, but this technology was no longer providing the desired output. 

As the requirements of modern plastics become ever more complex, Schenck Process provides plastics processors with equipment and systems that handle their bulk materials with precision.

ProcessMaster is the perfect flowmeter for various industries: chemical, power, water and waste water, oil and gas, pulp and paper, metal, and machine construction.

By OSIsoft

A mandate for overall cost-cutting at chemical companies once triggered a tedious process where plant staff would cram into meeting rooms to pore over spreadsheets, generate potential improvement lists, and attempt to rank the best ideas. While the exercise proved to be somewhat intuitive based on collective experience, much of it missed the mark.

Agitated dryers give significantly higher drying rates per unit heating area than non-agitated systems such as ovens and tray dryers. This is due to continuous renewal of solids in contact with the dryer's heated surfaces.