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Case Study: How Lundbeck uses ELPRO cold chain monitoring solutions to streamline processes

In biomanufacturing, pharmaceutical, supply chain by Alicia CheungLeave a Comment

Project Partner Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with psychiatric and neurological disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at disease areas such as depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease. Project As a large R&D organization with clinical sites around the world, Lundbeck needed a cold chain monitoring solution that streamlined end to end processes communicating temperature data that would ensure successful clinical trial progression and cost-effectiveness. In addition, it was their priority to meet new GDP requirements to demonstrate control during transport by collecting data and having an auditable database.

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Pharma Supply Chains: Transitioning to the Modern World of Data Monitoring and Analysis

In biomanufacturing, pharmaceutical, supply chain by GenerisLeave a Comment

In the world of pharmaceutical supply chains, where cost reduction is king and a growing number of products are temperature-controlled – collecting, communicating and analyzing temperature and logistics data is critical to success. If data is the foundation of business intelligence, why are Pharma companies still using old practices for data analysis – reviewing data by hand, doing manual entries and archaic reporting methods? All of these outdated practices and long processes create human error and surging hidden costs. Today, all of the important temperature data and automation tools are at the industry’s fingertips, so why not use them?

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Manufacturer Exits Paper Trail – Moves to a Software Path for Better EHS Management

In aerospace, biomanufacturing, manufacturing, manufacturing operations, operational excellence by Harshini SrikanthanLeave a Comment

It was really a matter of getting with the times. PACE Industries, a U.S.-based die-casting company, was not unlike many organizations struggling to manage environmental, health and safety (EHS) processes. They were looking to get out of the old world of paper and Excel spreadsheets and into the modern age of intelligent digital reporting. A company with a history dating to the 1970s, PACE was buried under a spreadsheet mountain of incident reporting from 12 divisions and 21 locations throughout the U.S., plus two plants in Mexico. It’s a busy place. You name it, and PACE probably manufactures it, taking aluminum, magnesium and zinc, melting it down, putting it in high-pressure molds, and literally turning it into thousands of parts. Everything from components for the automotive and lighting industries, to barbecue grills, and even guidance chips for missile systems. Suffice to say, paper-based processes simply weren’t cutting it.

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Gather, Predict, Change: How Smart Leaders Tame Risky Systems

In aerospace, automotive, biomanufacturing, manufacturing, operational excellence by Harshini SrikanthanLeave a Comment

Manufacturing organizations face an increasingly complex and unforgiving Environmental, Health & Safety and Quality (EHSQ) environment. Yet, many companies are still relying on traditional tools to manage EHSQ risks that fall short of meeting today’s challenges. Intelex Technologies’ white paper, “Gather, Predict, Change: How Smart Leaders Tame Risky Systems,” provides an overview of the limitations of traditional EHSQ management approaches and outlines three steps to developing a proactive, forward-looking, system-level approach to managing EHSQ risks. Get your copy today: http://bit.ly/2FVmYm2.

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Biopharma M&A Outlook for 2018

In biomanufacturing, Life sciences, pharmaceutical by Cressida MurrayLeave a Comment

Biopharma M&A activity has already been big news in 2018. On  January 22, it was reported that Celgene had bought the 90% of Juno Therapeutics it did not already own for $9 billion, just weeks after they announced the purchase of cancer startup Impact Biomedicines.  This news fits within a few broader trends we are seeing in the biopharma industry and sets the tone for this year, in which we expect to see a lot more M&A activity in the industry. Tax reform in the United States, particularly a lower levy on US companies’ overseas cash, means we will see companies repatriating these funds and likely spending them on M&A activity. This M&A activity will lead to consolidation in increasingly-crowded categories, such as cancer therapy, and there will be a continued focus on young or early-stage development companies.

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Addressing the Challenges Facing the Biomanufacturing Industry in the Next Five Years

In biomanufacturing, biotechnology, capacity management, pharmaceutical by Cressida MurrayLeave a Comment

Last year, at the American Biomanufacturing Summit, we sat down with some thought leaders from MedImmune, AstraZeneca, Pfizer, Takeda, Celgene, and Portola Pharmaceutical and asked them: “What do the Next Five Years Look Like in the Biomanufacturing Industry?” Most agreed that it will be an exciting time with new product modalities improving patient care, but that these new product modalities will give rise to new challenges in capacity and raw material sourcing, as well as talent recruitment and management. We asked them to go further and tell us what key challenges organizations need to overcome to be successful in this period of unprecedented change.

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Additive Manufacturing in Medical Devices: Insights from J&J and the FDA

In 3D printing, additive manufacturing, biomanufacturing, innovation, manufacturing, medical device by Cressida Murray1 Comment

One of the promises of additive manufacturing is the ability to go after niche markets with low volume production of unique parts. What application could be more apt for this technology than the human body? Last month, the FDA issued a statement providing guidance to manufacturers on technical aspects of additive manufacturing, clarifying what the FDA recommends manufacturers include on submissions for 3D printed medical devices. The FDA has, so far, approved over 100 3D printed medical devices, including knee replacements, custom skull/facial reconstructions, and even a 3D printed drug, called Spritam, which is used to treat seizures. The FDA has categorized this technical guidance as a “leap-frog” guidance, explaining that it is just a mechanism to share initial thoughts in order to bridge where we are today with the innovations of tomorrow.

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What Do the Next Five Years Look Like for the Biomanufacturing Industry?

In biomanufacturing, biotechnology, capacity management by Cressida MurrayLeave a Comment

Last year, at the American Biomanufacturing Summit, we sat down with some of our thought leaders to ask them where they see the industry going in the next five years. It was clear that major changes are on the horizon. It will be an exciting time, with new product modalities improving patient care, but giving rise to new challenges in capacity and raw material sourcing, as well as talent recruitment and management. Read on for insights from thought leaders at MedImmune, AstraZeneca, Pfizer, Takeda, Celgene, and Portola Pharmaceutical.

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Smart Outsourcing: Strategic Alignment, Risk Management, and New Relationships

In biomanufacturing, healthcare technology, Life sciences, logistics, manufacturer, manufacturing, marketing, medical device, pharmaceutical, technology by GenerisLeave a Comment

Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials. The industry is rapidly changing; companies are facing rising costs, a fast evolving global market, and weak pipelines. Many companies are outsourcing activities that have historically been kept in house, freeing themselves to concentrate on their core competencies and become more agile in responding to changing conditions. These new outsourcing models include discovery and R&D, regulatory, chemistry and manufacturing controls (CMC) support, and back office sales and marketing activities—virtually no activity is out of bounds. Instead of building or acquiring specialized technologies and facilities, many companies are seeking access to them elsewhere. Smart outsourcing provides the following operational and business benefits: To learn more about smart outsourcing and what the operational and business benefits are, check out this white paper by OQSIE 

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Are You Forgetting Something In Your Single-Use Strategy?

In biomanufacturing, biotechnology, Generis, generis group, innovation, manufacturer, manufacturing, manufacturing operations, system design by GenerisLeave a Comment

In your experience, what has the outcome been like when an organization has taken the time to improve its’ single-use strategy? The first thing people sigh in relief about is that there is no danger of breathing in particles and that they are dispersing all over the manufacturing facility. Once the system is closed, there is no longer so much time spent on cleaning and validation. In addition, it helps speed up the process making it so there is one less bottleneck on the road to continuous manufacturing. To learn more about single-use strategy and make sure you are including everything you need, check out the full ebook by ILC Dover below! 

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