Whitepapers

Extractables and leachables (E&L) testing for packaging-related impurities is essential to ensure cGMP compliance and, most importantly, patient safety.

Ensure the success of clinical biomanufacturing programs by focusing on key tech transfer practices from the sponsor, commercial, scientific, and program management stakeholders.

One of the causes of crimp variation that can lead to integrity failures due to poorly sealed vials has been reported to be component dimensional variation. Critical dimensions of the components of a vial system (vial, stopper, and cap) can vary within manufacturing tolerances, but these ranges of variation may require adjustments to the capper settings to ensure a proper package seal.

Explore QualTrak to find the right bioanalytical tools by modality, phase, and applications. Optimize biopharmaceutical drug development with suggested efficient workflows supported by consistent assays & reagents manufactured under GMP manufacturing principles, automated instruments, premium service & support, and a vertically integrated supply chain. The Applied Biosystems family of most-cited qPCR solutions is designed to simplify your process and expedite your results. Stop wasting your time in page hopping to find bioanalytical tools. And check out this once centralized location for qPCR, dPCR & CE workflows!

Partnering with a CDMO with collective insights and capabilities to support the development and manufacture of an innovative biotherapeutic program is an essential first step to providing better care to patients.

Dr. Luca Mantilli, an R&D chemist at Valsynthese, shares his insights into the company’s journey with phosgene, an exceptionally versatile reagent that offers various synthetic possibilities.

Lipid-based formulations (LBFs) are complex mixtures of lipid, surfactant and solvent excipient, where the composition determines the potential impact of dispersion and digestion on drug solubilization. By carefully selecting fill formulations during the early stages of drug development, it is possible to meet the specific requirements for bioavailability and stability for clinical trial and supply.

Various impurities can infiltrate the container closure system in pharmaceutical manufacturing. Understanding nitrosamines, elemental impurities, extractables, and leachables can help ensure the safety of the final product.

Knowing the right time to introduce cGMP raw materials when scaling up mAbs manufacturing avoids production process redevelopment, delays and increased costs. Using cGMP grade reagents earlier makes for a seamless transition while maintaining quality and viability. Learn key considerations for a seamless scale up process in our GMP fact sheet.

Buffers are used in great quantities when producing monoclonal antibodies (mAbs), and many biopharmaceutical companies — even large ones — do not have the processing capacity or infrastructure in-house to handle these large volumes. Whether it’s providing quality, pre-weighed, GMP-compliant raw materials or the entire buffer preparation step, there are options available to optimize your process.

As the most expensive stage of monoclonal antibody production, downstream processing presents numerous opportunities to increase efficiency and raw material performance. This article discusses advances in purification process materials, as well as emerging technologies to aggregate and analyze data, as possible solutions to these challenges.

Lipid-based formulations can improve the oral bioavailability of some molecules. However, a poor understanding of the technology and complexities limit their use.

It is essential to have access to the right tools and expertise to support process development for biologic therapies, from the clinical trial phase to commercialization.