Whitepapers

Oral drug products that contain highly potent active pharmaceutical ingredients (HPAPIs) continue to be a driving force in the global pharmaceutical market. In this Q&A article, industry experts discuss some of the challenges in HPAPI drug product manufacturing and the key issues sponsors should consider when partnering with a contract development and manufacturing organization (CDMO).

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The level of containment necessary for a potent drug product is not just limited to potent or non-potent classification. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility. This article discusses how to effectively classify highly potent APIs (HPAPIs), and to help develop containment protocols and manufacturing processes that are both safe and efficient.

Understanding the interplay between product and process is key to overcoming the challenges in the development of powders for deep lung delivery.

Catalent’s approach to containment mitigates cross-contamination risk and regulatory issues, ultimately safeguarding patients. Download this article written by Karolina Narczykiewicz, an EHS expert at Catalent Pharma.

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.

Consistent quantification using qPCR and dPCR technology is essential for obtaining accurate and precise viral vector titers.

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.