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By Fiona Barry, associate editor, PharmSource GlobalData
As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers.
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By Crystal M. Booth, PSC Biotech
Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements. In this final part, we examine what to include in quality agreements and who should be responsible for the assigned tasks.
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Article
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By Dominic Hyde,
Pelican BioThermal
As we welcome the new decade and the exciting advances it is expected to unleash, many of the forces that shaped the past decade for transporting pharmaceuticals will continue. Price pressures, alternatives to air freight, and increasing automation are just a few. However, there are emerging trends that make 2020 unique. As we look forward, these are the air cargo trends expected to shape the transport of pharmaceuticals in 2020 and beyond.
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Article
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By Sridhar Krishnan,
Pharmaceutics International
There are no shortcuts to growing capacity that delivers results faster, and maintaining it is difficult. The key ingredient in growing enterprise value is sustainability. Learn how, by applying the principle of sustainability using its four dimensions, finite resources are more wisely used with extraordinary results, lead time from concept to commercialization is greatly improved, and patients receive better medications faster.
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White Paper
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By Frank Ritacco and Daniel Baskind,
Thermo Fisher Scientific
Using a risk-based approach to generate an appropriate control strategy will help ensure your product meets characterization and validation requirements, enabling timely approval and launch to market.
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White Paper
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By Zak Yusoff,
SP Scientific Products
Biologics drugs have shown great promise in curing many life-changing diseases, even some that were once thought incurable. However, due to the sensitive nature of biological material, it requires specialized development and manufacturing processes. Stabilization by lyophilization is attractive to retain the product’s biological activity, structural integrity, and homogenous quality, all of which are crucial to the success of the product. This white paper describes the challenges associated with lyophilization of biologics drug products.
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Case Study
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By Janice Abel,
Seeq Corporation
This pharmaceutical manufacturer’s goal was to minimize the traditional scale-up challenges when moving from pilot production to commercial manufacturing. Read how they are utilizing the OSIsoft PI System data infrastructure and piloting Seeq’s analytics to optimize its product and processes to support continuous manufacturing.
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Case Study
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By Zach Wagner,
OSIsoft
Genentech’s transition of 20+ years’ worth of data from a legacy historian to OSIsoft’s PI Historian resulted in greater system stability and improved user access.
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Article
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Lonza Pharma & Biotech
Moving too quickly can open your drug development program up to many risks, making it critical to achieve the optimal program profile for a seamless transition from gene to IND and beyond.
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Article
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Thermo Fisher Scientific
Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success.
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Article
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Wipotec-OCS
As the cannabis market grows, so does regulatory agency cannabis tracking requirements. Let's look at some of the cannabis hardware and software packaging solutions that provide increased profitability and reporting accuracy.
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White Paper
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Dassault Systèmes Americas
As science-based organizations look to leverage the Internet of Things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms.
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Case Study
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Mettler-Toledo Product Inspection
Teligent produces a diverse range of generic prescription topical and injectable pharmaceuticals. To automate inspection on their high-throughput tube line, they turned to a checkweigher with a two-lane configuration that matches their dual-lane filler.
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Case Study
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Almac Group
p An alternative solution to the build or buy decision is the use of readily available, prequalified GMP facilities that can be fully tailored to suit individual needs and budgets.
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ebook
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IDBS
Is your company ready to take full advantage of the data you generate to compete in the global digital economy? Are your laboratories able to efficiently generate high-quality data and easily store, manage, and process that data? Can your scientists easily communicate and collaborate with partners around the globe? Many companies, unfortunately, are still operating with legacy data management systems that bog down their efforts at innovation; some even still capture data on paper. Read on to explore some of the challenges and opportunities of transforming your lab into a truly digital lab of the future.
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ebook
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Thermo Fisher Scientific
There are many factors to consider when choosing a perfusion medium. Two such factors are ease of use and cost-effective performance. This ebook explores how to choose a perfusion medium and shares case study examples of N-1 perfusion for accelerating the seed train and concentrated fed-batch processes for increasing productivity.
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Video
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Cytiva - Cell & Gene
Realize a more controlled, assured, and patient-focused way of shipping cell and gene therapies with the VIA Capsule System. Easily charge this liquid nitrogen-free system using electricity. Securely load the cell therapy using your defined process, and capture records digitally. Integrate activities across the manufacturer, courier, and clinic while maintaining an electronic record of the shipment conditions, location, chain of custody, and identity. If needed, use the shipper for temporary cryogenic storage. When the patient is ready, wheel the shipper in.
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Webinar
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Dec Group
The trend toward prefilled disposable syringes, whether of the single- or dual-chamber type, is increasing. This webcast concentrates on the aseptic pharmaceutical packaging process challenges that need to be addressed in the final filling process of dual-chamber syringes, where both liquid and powdery substances are mixed by the patient immediately prior to injection. This practice shows clear advantages as it can eliminate preservative needs while enabling longer shelf lives.
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Pfizer CentreOne Contract Manufacturing
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West Pharmaceutical Services, Inc.
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AES Clean Technology, Inc.
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PLGA Parenteral Excipients For Extended Release
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Webinar
Tuesday, November 3, 2020 | 10:00 a.m. EDT
Poly(lactide-co-glycolide) (PLG) parenteral excipients have been used for many decades with extended release microparticle, nanoparticle, implant, and in-situ forming drug products due to their excellent bioabsorption and biocompatibility characteristics, and their long safety record. This webinar will give an overview of key PLG properties relevant to drug delivery formulations including tunability.
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Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.
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