Whitepapers

Kindeva’s microneedle array patch platforms for solid and liquid APIs have the potential to deliver far-reaching clinical, environmental, and usability benefits.

In the decades since its creation, the autoinjector has changed lives globally. This article charts evolutions in this essential device, including considerations for today’s next-generation autoinjectors.

Our facility in Bridgeton, MO, delivers Annex 1 compliance with every line. Along with our other facilities in the St. Louis area, this site makes us one of only a few CDMOs capable of servicing sterile fill, device manufacture, and final assembly in one geographic location. This saves you time and money while reducing your carbon footprint.

Compliance and quality are not the same thing. While compliance means manufacturers demonstrate they meet regulatory requirements, quality is foundational to patients’ confidence in the safety and effectiveness of their medications.

Continuous Manufacturing in pharmaceuticals can increase process understanding while overcoming disadvantages of batch manufacturing: slow and expensive development and tech transfer, plus inefficiencies, product loss, and human error in commercial manufacturing.

What innovations can help drug manufacturers and developers mitigate risks, reduce turnaround time, and increase success in early phase Cell & Gene therapy development?

Lonza Small Molecules is focused on leveraging its technologies and expertise to address solubility challenges and support drug development programs through commercialization.

Implementing automation involves careful optimization and fine-tuning of various parameters to ensure the accurate execution of cell-based potency assays.

Sara Greco, R&D Chemist at Valsynthese, part of the SSE Group, covers the beneficial properties of polyimide materials and the key role that aliphatic anhydrides play in the enhancement of those properties.

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.