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.
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...
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....
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...
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...
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,...
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...
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...
Hydrogen Peroxide: Is Material Compatibility a Real Challenge for This Decontamination Technology?
One of the most important challenges of the hydrogen peroxide technology has traditionally been the material compatibility. The high oxidation potential...
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...
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....
As a result of the changes introduced by EU GMP Annex 1 on the Manufacture of Sterile Medicines and despite the fact that it has not yet been finally approved as of today, some pharmaceutical laboratories with sterile production have decided to move...
HOW GXP-COMPLIANT SAAS PLATFORMS FACILITATE THE PROCESS
Explore a Quality by Design (QbD) approach to applying Artificial Intelligence (AI) in pharma manufacturing; and demonstrates how GxP-compliant AI software can be leveraged to qualify AI algorithms...
Microbial contamination is the biggest risk that faces the pharmaceutical industry today in terms of making products that meet safety, quality, and efficacy requirements. A couple of the many risks associated with microbial contamination in...
5 Practical Ways to Proactively Avoid Data Integrity Issues for Improved Quality
Pharmaceutical and biotechnology companies are no strangers to FDA 483s and warning letters. In fact, the categories of Devices and Drugs accounted for the second- and...
Perfusion processes offer key advantages to fed-batch processes and are now possible thanks to recent advances in cell retention technologies, cell line, and media development. What features should such technologies have to achieve performance,...
In-line Control of CO2 Accumulation for Improved Cell Culture Processes
Controlling dissolved CO₂ measurement in mammalian cell culture processes is growing in acceptance. In an ex-vivo culture model, for example in a bioreactor, measuring and...
GMP Warehouse Mapping: Step-By-Step Guidelines for Validating Life Science Storage Facilities
Good manufacturing practice (GMP) requires mapping studies to profile and document conditions in warehouses, distribution centers, and storage facilities. This...
BioContinuum™ Automation & Analytics Platform
Bio4C™ ProcessPad Software
Biopharmaceutical processes are complex and highly variable in nature. This can result in inconsistent and sometimes unpredictable process outcomes. To manage complexity and...