02.18.21 -- 7 Rules For Properly Interpreting Control Charts

The future of biopharma manufacturing will be shaped by how we collect and use process data. Find out how preparing for a digital transformation can provide your business actionable information and true value.

Modular cleanroom systems are increasingly chosen over a conventional construction approach due to their accelerated design and installation schedule advantages, as well as their reduced job-site safety risks during installation.

The expectation — just as it is with biologics — is that the process is the product. However, cell and gene therapy products have unique features that must be considered during process validation.

For certain molecules, the most appropriate technology for bioavailability enhancement and accelerated development will be lipid-based formulations (LBF), supported by in silico development tools. Senior formulation and product development scientists analyze the potential benefits and applications of lipid/liquid-based formulations and how they may reduce timelines to clinical trials.

The following criteria will help a lab manager train users and maintenance staff on protocols to keep the ultra-low temperature (ULT) freezer running optimally and reliably for cell preservation.

To ensure patient safety, pharmaceutical products must be kept properly packaged prior to use. Proper packaging prevents ingress of contaminants. Unfortunately, these contaminants are not always visible to the human eye and container closure integrity (CCI) tests must be performed to ensure the package has not been compromised. One way to test for proper CCI is to analyze the headspace gas composition of the vial.

The pharmaceutical and biopharmaceutical industries are facing new challenges with powder handling on a scale that has never been seen before. In recent years, production facilities across the globe have been required to handle an ever-increasing amount of powder, creating bottlenecks and inefficiencies throughout the entire product pipeline. In this e-book, we discuss the various challenges of powder handling and set forth solutions for handling media and buffer powders.

Since it is very costly to rework a drug formulation due to an incompatibility with its packaging, combination product regulation drives the early understanding of drug/container compatibility for the intended use. This poster provides two case studies to show how West assesses drug/packaging interactions and demonstrates the importance and feasibility of taking the container system into consideration in the early drug development stage.

There is a great need for innovative technologies that can improve the success rate for new drug candidates and pave the way for novel therapies to reach the market. Recent advances in nanoparticle engineering technology promise to accomplish precisely this.

As the cannabis market grows, so does regulatory agency cannabis tracking requirements. Let's look at some of the cannabis hardware and software packaging solutions that provide increased profitability and reporting accuracy.

Keeping an eye on some emerging trends that are shaping society and the pharmaceutical industry can help you meet diverse consumer preferences and potentially extend product life cycles.

What technical considerations should be at the forefront for your oral solids project? This two-part series features four oral solids experts from Pfizer CentreOne’s global network and partner organizations discussing the technical considerations to be aware of. In the second installment of the series, our experts consider the effects of equipment design and different tablet strategies.

Engineers and subject matter experts within operations settings are tasked with driving operational excellence to improve quality, safety, and throughput in production operations. The new technologies proliferating as part of Industry 4.0 initiatives are raising and expanding performance expectations. Rapid data-driven insights are becoming critical to balance resiliency and agility with efficiency. As an IT professional, supporting these efforts is imperative as operations leaders grapple to get the most out of investments in technologies that generate and use large volumes of data.

How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprints and overall cost in buffer preparation.

Hydrogels are very compliant materials suitable for tissue engineering in various areas of biological and clinical research. Appropriate and effective application of hydrogels for specific cellular regeneration often requires precise knowledge of their mechanical properties. This application report focuses on the measurements of mechanical deformation and creep properties of polyacrylamide hydrogels using the Anton Paar Bioindenter.

With IBD and virus filtration making up a significant portion of AKBA’s business, it is critical their equipment and systems meet the strict operational needs of the manufacturing systems used by their clients.

This e-book explores how to choose a perfusion medium and shares case study examples of N-1 perfusion for accelerating the seed train and concentrated fed-batch for increasing productivity.