Whitepapers

Media manufacturers must offer global redundancy at harmonized manufacturing facilities to enable streamlined capabilities–especially for their customers outsourcing proprietary cell culture media formulations. This paper details Thermo Fisher’s manufacturing equivalency approach utilized at two global facilities located in Miami, Florida, and Grand Island, New York.

The importance of successfully scaling up cell culture media cannot be overstated. Not starting the process soon enough can introduce issues with solubility, manufacturability, procurement, and cost management. This article considers technical and commercial best practices that drug developers may enact so that they, their suppliers and media manufacturers, and in turn, their cell culture media remain on the most efficient path to market.

In this project, Thermo Fisher Scientific worked with a multinational biopharmaceutical company to investigate trace element variability in its custom cell culture media. Within a year, using a risk-based, collaborative approach, both teams were able to thoroughly characterize incoming specific raw materials and implement proactive measures for reducing the risk of impurities, ultimately providing the company with a long-term risk mitigation strategy.

Automated HPLC method development and robustness tests for abacavir, lamivudine, dolutegravir, and their related compounds in Triumeq drug product.

Out-of-the-box usability of Thermo Scientific™ UltiMate™ 3000 and Vanquish Core HPLC instruments for the compendial analysis of commonly prescribed drugs.

Development of a robust LC method for metolazone and related impurities using analytical quality by design best practices.

Quality control (QC) testing of pharmaceuticals must be rigorous and involves multiple techniques including GC-MS, LC-MS, IC, and elemental analysis techniques.

Method modernization is often less difficult than the common perception, and good practices can be put in place to streamline and facilitate the process.

For tech transfer of sterile injectables, vetting CMO partners means more than availability of facilities or the equipment, CMO partners should offer end-to-end support

Process equipment used in the healthcare and pharmaceutical industries follow rigid specifications for accuracy, consistency and cleanliness.

This application note demonstrates that the Agilent 6475 triple quadrupole LC/MS system can confidently quantify nitrosamine impurities at the low concentration levels specified by regulatory requirements. This method can be used to quantify these impurities in different ARB drug products, with some changes in chromatographic conditions based on the elution pattern of the drug product.

For studies involving products such as biologics and biosimilars, maintaining reliability of clinical supply can be challenging. Explore how different cold chain strategies can be leveraged to maintain product integrity in transit and minimize disruptions to clinical supply.

This eBook outlines how a CDMO specializing in advanced modalities can help sponsors to create a reliable and streamlined autologous cell therapy supply chain that maintains product quality, integrity, and compliance.

In this executive summary, learn how taking a parallel & integrated approach to drug substance development, drug product manufacturing, & clinical supply can significantly shorten the time from development to clinic for a biologic drug.

This white paper details the challenges to optimizing the emerging supply chain, from manufacture through clinical trials to market, and how they may be overcome.

Partnering with Spark Global and Stanford University, startup CDMO, Bravado Pharmaceuticals, uses a creative approach to survive during the Covid pandemic.

Review testing requirements for lab balances in the pharmaceutical industry described in the relevant pharmacopoeias and the associated certificates offered by Sartorius.

Unlock the full potential of your pharma/biopharma laboratory with our comprehensive guide on mastering liquid handling techniques for any liquid type.

A growing proportion of drugs in the development pipeline nowadays start out life at small biotech companies, rather than big pharma businesses. While this means the biotechs are taking on more risk, they will also reap greater rewards in the event of success. When it comes to choosing your CDMO partner, there is no substitute for a careful selection process to determine the right CDMO to make and manage your precious potential drug. In this podcast, David Hall, Senior Director, Commercial Development at Lonza Small Molecules, provides insights on how small and emerging pharmaceutical and biotech companies can navigate the evolving pharma development pipeline.

To help navigate supply chain risks and avoid drug shortages, PCI have created a quick reference guide to recent draft FDA Guidelines: Risk Management Plans to Mitigate the Potential for Drug Shortages.

A key hurdle for any drug development program is bringing the drug to clinical studies. Astute companies strategize past this milestone and plan for clinical and regulatory success. Lack of preparation for scale-up activities needed for eventual commercialization can often cause major time delays, increased costs, and a significant amount of rework. This eBook provides insights on key approaches and considerations for preparing your program for long-term success.

Advances in silico and experimental techniques mean that APIs and prototype formulations can be thoroughly characterised using multiple material sparing assays, allowing the most promising formulation candidates to move on to in vivo studies.

Thousands of drug candidates are abandoned annually due to solubility and bioavailability issues, but advanced formulation technologies can profoundly impact how a drug compound is processed in the body and improve the fate of many of these candidates, improving pharmacokinetic profiles and pharmacodynamic responses. Two Catalent experts discuss the ways companies can address issues with low bioavailability, and the benefits of enlisting an experienced drug development partner.