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To help meet the needs of the fast-growing, global biopharmaceuticals industry, Pall Corporation has launched five innovative technologies aimed at increasing drug-manufacturing efficiency through customization and disposability. The Mustang XT5000 capsule is the company's novel chromatography technology for efficient capture of large molecules, especially used to develop DNA and virus-based drugs. Expanding its portfolio of technologies for disposable processing, Pall offers both the customizable Tangential Flow Filtration system, which incorporates single-use components for downstream processing applications, and the Kleenpak Connector — a new single-use device, which enables aseptic connections to be made instantly.
New technologies help drug manufacturing efficiency
To help meet the needs of the fast-growing, global biopharmaceuticals industry, Pall Corporation has launched five innovative technologies aimed at increasing drug-manufacturing efficiency through customization and disposability. The Mustang XT5000 capsule is the company's novel chromatography technology for efficient capture of large molecules, especially used to develop DNA and virus-based drugs. Expanding its portfolio of technologies for disposable processing, Pall offers both the customizable Tangential Flow Filtration system, which incorporates single-use components for downstream processing applications, and the Kleenpak Connector — a new single-use device, which enables aseptic connections to be made instantly. For higher performance depth filtration, the company also offers its SUPRAdisc HP to allow more efficient cell harvest and clarification steps for drug processing. Finally, Pall has updated its operating software, which simplifies operation of complex systems.
Pall's Mustang XT for production chromatography.
A PAT solution for online moisture measurement and control has been developed by Invensys Validation Technologies in conjunction with Mathis Instruments. The innovation provides both a system for automated, online moisture monitoring during drying and automated control of the fluidized bed dryer. By using effusivity, it only takes a few days to characterize a new product, which contributes to shortened development time.
"By integrating Mathis effusivity sensors into a comprehensive analysis and automation solution, we can provide our mutual customers with a unique PAT solution that will help them improve the quality and performance of their manufacturing processes," commented Mark Cupryk, VP of Invensys Validation Technologies.
Honeywell has unveiled its Experion R300 Process Knowledge Platform. The company believes the product offers customers the opportunity to reduce their total installed automation cost and improve their productivity.
"With the influx of commercial-off-the-shelf-technology in control hardware, it is increasingly difficult for process automation system suppliers to add value at the hardware layer of the system, particularly at the controller and I/O level," said Larry O'Brien, ARC research director. "Honeywell's new vertical design is unique in the industry and provides the reduction in real estate and footprint that has increasingly become a concern for users .... Honeywell's steps to address the issue of cyber security with embedded control firewalls and a more secure network architecture is also addressing key user concerns regarding the vulnerability of automation systems," added O'Brien. "By improving maintenance efficiency and reducing the number of system components, Experion R300 offers higher availability than before and the potential to help customers avoid costly unplanned downtime."
Honeywell's Process Knowledge Platform.
LevTech Inc. and Sartorius AG have made a global distribution agreement for LevTech's novel mixing system that employs a levitated single-use impeller in disposable pharmaceutical grade bags. The company's breakthrough technology uses traditional impeller-based mixing dynamics without shafts, seals or bearings and thus, eliminates particle and heat generation, bearing or seal failure and stress on the bag. The DB-200E/EA is portable and mixes efficiently at scales suitable for development through large-scale processing, while eliminating the need for cleaning and sterilization between runs, processes or products.
GEA Filtration has launched its new Type 'R' Pharma Pilot Plant for the recovery of a wide range of active pharmaceutical and biotech products in accordance with cGMP. The plant is suitable for use in clean rooms to perform pilot studies on the full range of filtration technologies, and has the versatility to house a variety of membrane configurations with a membrane area of up to 14 m
. Designed for batch or continuous operation and automatic CIP, the system is reported to provide accurate test results, with reliable scale-up to full production, and uses frequency-controlled pumps to minimize product damage. The unit is also available in XP form for use with nonwater solvent systems with potentially explosive characteristics.
New system overcomes stainless steel restrictions
Millipore has introduced its Pod platform, an innovative filter system for normal flow clarification and prefiltration applications. Designed for greater process flexibility and productivity, the patent pending disposable technology improves process speed, safety and economics in the manufacturing of biopharmaceuticals. The Pod platform consists of an expandable holder and modular filters that overcome many operational limitations of tradition stainless steel housings. Developed as a self-contained device, each Pod is a single-use filter that reduces the need for CIP procedures. In addition, the unit delivers process scalability and flexibility. Without changing hardware, users can run their system in serial or parallel configurations to meet specific process and batch size requirements of 20–12000 L. Pods are available with the company's Millistak+ HC media for use in primary and secondary clarification processes.
The Pod filter system for process flexibility.
If pharmaceutical companies are able to adapt to changes in patient population and target diseases of unmet medical need, the global pharmaceutical market could reach $967 billion, according to Frost & Sullivan. In 2004, the market was estimated to be worth $554 billion, but multiple challenges lie in the way of the industry realizing its potential. High clinical development costs, declining drug discovery success rates, imminent patent expiry of several blockbuster drugs and the related rise of cheaper generic alternatives are all barring the way to progress and profit.
"It is essential for major pharmaceuticals companies to move from the blockbuster model and adopt new strategies that cater to specific diseases areas and populations. To grow in this new era of evidence-based personlized medicine, companies should generate a sustainable product pipeline characterized by improved productivity and diversity," commented Frost and Sullivan healthcare analyst Phil Webster. "Less investment will be lost through late stage drug candidate failures as more compounds succeed in the clinical development process. More techniques to identify toxic or ineffective drugs early in the development process such as the use of biological models, bioinformatics and biomarkers will drive down development costs, increase revenues and improve overall industry productivity," Webster elaborated.
A novel compact airlock sieve from Russell Finex is reported to improve product containment, and operator health and safety. With powders safely contained, the screener accurately removes any contamination. Oversize contamination is removed by the mesh screen fitted to the unit, while the good product passes through and on to the next stage of production. The pneumatic lock, which clamps the ATEX-compliant unit together, gives an even and high clamping force across all sealing faces and, therefore, guards against powder leakage more effectively than traditional band clamps or over-centre toggle clamps. According to the company, the sieve fits neatly into any part of the production process, providing considerable screening capacity with little headroom. It is ideal for check screening incoming ingredients on the primary side right through to finished powders in secondary production facilities.