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iSpeak Blog
CSL is an Australian-owned global biotechnology company with a portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Founded in Melbourne in 1916, CSL today comprises three businesses—CSL Behring, CSL Seqirus, and CSL Vifor—that provide lifesaving products to patients in...
iSpeak Blog

Quality control (QC) manufacturing labs are ripe for transformation. Historically relying on legacy systems and processes that require significant investment and customization to deliver value, it is time to think differently and explore alternative approaches. QC labs have an opportunity to adopt new strategies and tools to design a digital, more connected lab of the future.

iSpeak Blog
Touchlight's project, Development and Manufacture of Novel Synthetic DNA to Enable the Future of Genetic Medicines, transformed their Morelands facility, located in a historic Victorian waterworks building in Hampton, London, United Kingdom (UK), into a cutting-edge production facility for synthetic DNA technology "doggybone DNA" (dbDNA™). The renovation of the facility enabled Touchlight to...
iSpeak Blog
As the autumn leaves begin to turn, we approach an event I anticipate each year—the 2025 ISPE Annual Meeting & Expo, 26 – 29 October in North Carolina, US, a state renowned for its thriving life sciences ecosystem, and where I have lived for more than 20 years. This year’s 2025 ISPE Annual Meeting & Expo isn’t just another industry conference, it’s a convergence of thought leaders, innovators,...
iSpeak Blog
Cleanroom garments are worn by operators working in certified cleanrooms to protect the product and the processes inside the cleanroom from human sourced contamination and to maintain the integrity of the cleanroom. Selection and correct use of these garments has a significant impact on the performance of the cleanroom, an appropriate selection allows the use of lower air change rates as the...
iSpeak Blog

The validation industry is entering a transformative era. Amid rising regulatory scrutiny, evolving team structures, and a strong push toward digitalization, professionals across the life sciences are being called to do more, with leaner teams and tighter timelines.

iSpeak Blog
The pharmaceutical industry is rapidly evolving driven by new therapeutic modalities, increasingly personalized treatments, and growing regulatory demands. Because of the constantly changing environment, sterile pharmaceutical manufacturing must meet higher standards in terms of flexibility, precision, and efficiency. Traditional vial filling lines, which were once considered the standard in...
iSpeak Blog
The blog post, “FOYA Celebrates 20 Years of Innovation and Excellence in Pharma,” recounted the history of the Facility of the Year Awards (FOYA) and highlighted previous winners. From the start and over the years, FOYA has always aimed to set a high benchmark for its honorees and winners.
iSpeak Blog
In today’s competitive biopharmaceutical landscape, two consistent challenges face process engineers and manufacturers: improving productivity and reducing the cost of goods sold (COGS). Innovations in PAT have made it possible to address both. Among these, capacitance measurement has emerged as a reliable, real-time, in-situ tool for viable cell density monitoring, offering a direct line to...
iSpeak Blog

Each year, FOYA showcases innovation, excellence, and progress in the pharmaceutical industry. The winners exemplify state-of-the-art design, cutting-edge technology, and industry best practices, continually setting new standards for what constitutes a winning project. This constant evolution keeps FOYA fresh and original, making it all the more remarkable that FOYA is celebrating its 20th...

iSpeak Blog

The pharmaceutical industry is experiencing a pivotal transformation. As professionals strive to develop therapies faster, more cost-effectively, and with greater precision, Pharma 4.0™ emerges as a powerful framework for change. This evolution is not only technological—it is cultural. It challenges organizations to become more agile, data-driven, and patient-focused.

iSpeak Blog
Cleanroom garments are worn by operators working in certified cleanrooms to protect the product and the processes inside the cleanroom from human sourced contamination and to maintain the integrity of the cleanroom. Selection and correct use of these garments has a significant impact on the performance of the cleanroom. Use of the optimum gowning reduces particle shedding and can allow the use of...
iSpeak Blog

The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace, while lowering drug costs, enhancing quality, and maintaining safety and a robust supply chain. Validation 4.0 ensures that validation processes are not a bottleneck but a strategic enabler of innovation, quality, and compliance by embracing artificial intelligence (AI), Internet of Things...

iSpeak Blog

The pharmaceutical industry is no stranger to innovation. From pioneering drug development to advanced manufacturing processes, it thrives on new ideas. But when it comes to construction, particularly the delivery of critical infrastructure such as laboratories, cleanrooms, and research facilities, many companies in the sector still rely on traditional building methods.

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