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Bringing the Freezing of Biopharmaceuticals in From the Cold
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Bringing the Freezing of Biopharmaceuticals in From the Cold
Integrated Solutions To Minimize Risk and Preserve Product Quality Introduction Do we dare treat drug substance freezing as an isolated process? Or should freezing be integrated with bulk filling, storage, shipping, thawing and fill-finish operations to deliver a multi-site end-to-end process that...
HEPA Filters - Key requirements for the pharmaceutical industry
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HEPA Filters - Key requirements for the pharmaceutical industry
What Is a HEPA Filter? HEPA is the acronym for “High Efficiency Particulate Air” or “High Efficiency Particulate Arrestance”. The HEPA filter is a type of mechanical filter. It works by providing a barrier in the form of a very dense filter media which is made up of very fine fibres that trap...
IT/OT Convergence: The Path to Pharma 4.0™
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IT/OT Convergence: The Path to Pharma 4.0™
To understand the modern life sciences manufacturing process, one must understand how the industry has transformed since the beginning of the “Industrial Revolution.”
AI in Tomorrow’s Pharma & Biotech Industry
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AI in Tomorrow’s Pharma & Biotech Industry
Artificial Intelligence (AI) is currently revolutionizing the healthcare system, in which AI-based software is increasingly becoming a part of medical procedures. AI will also play a key role in pharmaceutical manufacturing, helping companies to optimize processes. However, in pharma production,...
WFI: A Cost Review
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WFI: A Cost Review
When it comes to producing Water for Injection (WFI), capital, operating, and maintenance costs vary and some are assumed to be more economical than others. See what we uncovered in this cost analysis of four WFI systems including alternative WFI systems versus distillation technologies.
Exploring the Myth of Inert Excipients
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Exploring the Myth of Inert Excipients
API Stability in Solid Dose Formulation: Exploring the Myth of Inert Excipients Stable active pharmaceutical ingredients (APIs) represent a critical success factor for drug formulation. This white paper examines the potential impact of poor API...
How Technology Is Helping to Deliver Critical COVID-19 Projects
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How Technology Is Helping to Deliver Critical COVID-19 Projects
The COVID-19 pandemic is creating unprecedented challenges for communities around the world. As the biopharma sector responds to the urgent need to develop vaccines and treatments, solutions providers are deploying innovative digital solutions to support...
Major Advances in Magnetic Mixing Technology Permitits Broad Industrial Use
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Major Advances in Magnetic Mixing Technology Permits Broad Industrial Use
Magnetic mixing technology stands out with its many advantages compared to mechanically sealed agitators. In particular, the lower risk of contamination and the resulting cost reduction are powerful arguments for the application of magnetic agitators....
How an MES Supports Your Business Continuity
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How an MES Supports Your Business Continuity
Business continuity relies on resilience: the ability to successfully deal with crises like COVID-19, to keep manufacturing and supportive business processes alive and to adapt to environmental changes. Pharma and biotech manufacturers who invest in...
Addressing the Evolving Information & Automation Needs of Biopharma
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Addressing the Evolving Information & Automation Needs of Biopharma
As the biopharmaceutical industry evolves and new opportunities and challenges rise, manufacturers must keep pace. For example, a dramatic increase in the amount of information that is available, in parallel with a reduction in the cost of obtaining,...
Mannitol Polymorph Transformation in Continuous Twin-Screw Granulation
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Mannitol Polymorph Transformation in Continuous Twin-Screw Granulation
Wet granulation is commonly used in solid formulation to improve powder properties including size, flowability, dissolution rate, bulk density, compressibility and API uniformity. Mannitol has become a preferred filler/binder due to its low...
The Road to Continuous Process Verification (CPV)
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The Road to Continuous Process Verification (CPV)
Though not yet widely implemented, Continuous Process Verification (CPV) will soon become a necessity in pharmaceutical manufacturing, if companies wish to retain a competitive advantage. To enable CPV in the complex, multivariate operations of today’s...
Integration of Single Use Equipment: Hybrid Technology & Automation
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Integration of Single Use Equipment: Hybrid Technology & Automation
The hybrid systems that are created by the combination of single-use (SU) systems and stainless steel technology offer a range of benefits in terms of process control. The efficient connection of SU equipment to a stainless steel backbone is particularly...
Real-Time Release of Pharmaceutical Waters with On-Line Microbial Monitoring
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Real-Time Release of Pharmaceutical Waters with On-Line Microbial Monitoring
Culture based lab measurements of microbes can create challenges – Microbial monitoring in purified water, ultrapure water, and water for injection have almost exclusively depended on this time consuming and error prone culture based lab measurement....