Whitepapers

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.

A UHPLC method development system for efficient scouting of chromatographic elution parameters.

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.

API-sparing development techniques and identification of the appropriate scalable formulation technology to improve drug solubility and enhance oral bioavailability can help increase your chances of success when moving from preclinical development to early phase clinical trials.

Timely progression of a drug candidate into clinical trials is critical for pharmaceutical companies seeking to bring new products to the market. Streamlining chemistry, manufacturing, and controls (CMC) development can help accelerate this process, as well as help yield better success as the drug product moves through the early phase of clinical studies.

Developers anxious to move their small molecule to Phase I may not have the time or resources to fully characterize the druggability of their candidate. Issues that could delay or even derail the program may appear in later clinical studies. Catalent has the resources to characterize lead molecules and develop the best pathway to bring them to Phase I studies and beyond.

In this report, we will highlight the trends shaping the orphan-drug market, with a particular focus on expedited drug development. Expert insights on navigating development and manufacturing challenges with orphan drugs will be included, with insights on how drug sponsors of all sizes work with contract development and manufacturing organizations (CDMOs) to achieve their goals.

The development of orally administered small molecules is becoming more challenging as an increasing number of molecules in pipelines have poor aqueous solubility and bioavailability.

Lipid formulation and spray-dried dispersions are widely used, and proven technologies to overcome bioavailability challenges for poorly soluble molecules. For selecting the most suitable formulation technologies in early-phase development, formulation scientists regard efficacy, safety, bioavailability and stability as their top priorities. However, an early-phase formulation strategy should also consider scale-up and manufacturing challenges that may arise later in development. If bioavailability and manufacturing challenges are not addressed in early development, the cost and overall timeline of the project may be negatively impacted. Therefore, developing a bioavailable formulation that is easy to scale-up with superior dose uniformity is imperative for a product’s success.