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By Mark Durivage, Quality Systems Compliance LLC
If you do not want to be cited by the FDA, it’s time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements.
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By Vicky Qing Xia and Leo Cai Yang, BioPlan Associates, Inc.
Significant growth of outsourced commercial-scale manufacturing is projected for the near future in China, though certain bottlenecks remain.
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White Paper
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By Matt Hicks,
Federal Equipment Company
A variety of concerns –– notably underscored by supply chain disruptions driven by the COVID-19 pandemic –– are pushing companies to redraw their global supply chains to resume more domestic manufacturing, aided by new technologies and equipment that can reduce costs.
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White Paper
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By Dr. Induka Abeysena,
SP Scientific Products
As the novel coronavirus (COVID-19) pandemic is progressing throughout 2020, it has become evident that millions of testing kits are needed internationally every single day. This article explores how a leading provider of tools and technologies for genetic analysis, LGC, Biosearch Technologies, is aiding in the fulfilment of this demand, assisted by evaporation technology from SP Genevac.
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White Paper
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By Vincenza Pironti, Ph.D., Madhu Raghunathan, and Roman Hlodan,
Thermo Fisher Scientific
To achieve the benefits of moving a final product presentation from vials to prefilled syringes, it is important to understand the challenges during this process as well as practical solutions.
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White Paper
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By Sharon Nowak,
Coperion & Coperion K-Tron
An efficient feeding system can offer significant return on investment thanks to higher accuracy and better control, despite the higher initial capital investment.
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White Paper
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By Patrick M. Hutchins, Ph.D.,
TSI Incorporated
For years, the practical metric of airborne microbial contamination was the colony forming unit. Adapting growth-based approaches for monitoring today's aseptic manufacturing has sometimes proven difficult.
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Article
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By Praveen Bezawada-Joseph,
Thermo Fisher Scientific
What is the difference between qualification and validation? This question comes up frequently with both internal and external clients.
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Article
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By Anil Kane, Ph.D.,
Thermo Fisher Scientific
With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.
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White Paper
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Cytiva - Cell & Gene
This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development, all in order to prepare for successful commercial production.
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White Paper
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Thermo Fisher Scientific
This paper highlights six keys that pharma and biotech companies should keep in mind when selecting a partner to synthesize an API to ensure the development process tracks toward success.
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Article
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PCI Pharma Services
While the pandemic has had a massive impact on human health, it renewed our sense of purpose and presented an opportunity to leverage changes already underway so we can better serve patients. Read how it helped improve the supply chain industry for the better.
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Article
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Pfizer CentreOne Contract Manufacturing
A strategic partner should always seek ways to innovate and improve your compound or product’s value, and do it with the dedication of a partner, not a supplier. With the growing importance of contract services and plenty of providers, it is more critical than ever to make the right choice. Where do you start?
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Article
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SMC Ltd.
It is a constant challenge to keep improving product value for customers while reducing overall costs. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
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Application Note
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Cytiva
As process intensification is adopted into large-scale manufacturing, the responsibility on scale-down models to accurately represent the expanded operating space quickly follows. Perfusion continues to be one such operating model that lends itself to adding benefit at the manufacturing scale while adding complexity to the small-scale approach.
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Application Note
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Micromeritics Instrument Corporation
Across the powder handling industries screw feeders are used to control the flow of material from a dispenser or hopper into a process. The properties of the powder have a direct impact on the performance of the feeder, making it essential to tailor the design and operating conditions of any given system to the specific powder being handled.
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Case Study
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Mettler-Toledo Product Inspection
The midsize pharmaceutical company Krewel Meuselbach GmbH manufactures top-quality, affordable pharmaceuticals using state-of-the-art technology. Regarding traceability and prevention of product falsification, Krewel Meuselbach uses the compact XS2 MV TE system in a thermoforming line to ensure comprehensive quality control and prevent the falsification of its products.
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Case Study
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Wipotec-OCS
Reliability of the equipment, compact design, and user-friendly software are key factors in manufacturers’ choices for a track and trace solution.
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Webinar
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Alconox, Inc.
In this on-demand webinar we’ll look at detergent selection and chemistry, the important sanitary surface considerations for COVID-19, cleaning guidelines for cannabis manufacturers, overcoming difficult residues in consumer products and cosmetics, and even more.
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Dassault Systèmes Americas
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AES Clean Technology, Inc.
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Thermo Fisher Scientific Bioproduction
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Specialized Parenteral Excipients For Complex Products
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Tuesday, November 10, 2020 | 10:00 a.m. EDT/4:00 p.m. CEST
Bioresorbable functional polymers such as PLGA play an important role in long-acting and targeted injectable drug products. In this webinar, Evonik will present various excipients with properties that address the specific development and GMP manufacturing requirements of such complex products.
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Check it out today for access to candid interviews with top-tier executives on how they do business.
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