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Reducing Cleaning and Cross-Contamination Risk in Single-Use Powder Handling

In biomanufacturing, biotechnology, interview, Q&A by Alicia CheungLeave a Comment

In June 2019, ILC Dover will join biopharmaceutical executives to discuss current trends, strategic insights, and best practices in manufacturing, outsourcing, capacity management, quality assurance, quality control, regulatory compliance, operational excellence, supply chain, and logistics at the American Biomanufacturing Summit 2019. On June 2018, ILC Dover will present the topics, “Reducing Cleaning and Cross-Contamination Risk in Single-Use Powder Handling”. Their case study presentation will focus on how cleaning validation is getting more difficult as the industry gets better at detecting dust and particles; enabling rapid turnover of campaigns to get to market faster; and how powder handling is a bigger challenge than liquid handling, and why it is often overlooked as a potential source of contamination. Ahead of the American Biomanufacturing Summit, Generis spoke with ILC Dover to discuss their upcoming session, key challenges in the pharma and biopharma industries, and why companies choose to work with ILC Dover. This is an excerpt from the Q&A we did with ILC Dover: “What evolving containment needs are the pharmaceutical and biopharmaceutical industries currently facing?

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CMO and Pharmaceutical Company Relationships: What is the Client’s Role?

In CMO, manufacturing, pharmaceutical by Alicia CheungLeave a Comment

Over the last 25 years, contract manufacturing organizations (CMOs) have played an increasingly important role in the pharmaceutical industry. The need to decrease time to market, improve process efficiency, and reduce costs are all crucial reasons why pharma companies have an increasing use for CMOs – and they’re the same key factors that have propelled the growth of the outsourcing market and will continue to propel its growth over the coming years. A November 2016 study from Industry Standard Research Reports reveals that life sciences companies now outsource two-thirds of their manufacturing activities for CMOs. For small to mid-sized companies – where outsourcing manufacturing isn’t just a convenience, it’s a necessity – that figure is even higher: up to 80% in 2015. These partnerships often last many years and have the potential to either constrict or add considerable value to a company’es growth. Success relies, of course, on choosing the right manufacturer. But once the contract is signed, what are the responsibilities of the client to ensure effective collaboration and maximum productivity? Recognizing how the relationship can break down on the client’s side is a crucial step in reducing risks.

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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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Optimizing Temperature Control for Biopharmaceuticals

In biomanufacturing, biotechnology, Generis, industrial markets, innovation, Life sciences, logistics, manufacturer, manufacturing, mfg, pharmaceutical, quality, Quality by design, risk management, safety, supply chain, system design, technology by GenerisLeave a Comment

This article first appeared in BioPharm International, October 1, Caroline Hroncich Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey. This article by World Courier delves into these relevant industry topics: Common considerations for shipping biopharmaceuticals; Temperature management in extreme climates; Recent advancements; and Looking ahead. Learn more about optimizing temperature control for biopharmaceuticals in the article below!  

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