Whitepapers

Daniel Galbraith, Chief Scientific Officer (CSO) of Solvias provided a comprehensive picture to Pharmaceutical Technology of the current landscape of cell and gene therapy advancements. The discussion covers important regulatory guidance, technological landmarks, and how Solvias is impacting the current market.

Pharmaceutical companies rely on and trust BD to provide consistent testing outcomes for their critical tests, with the tools they need to effectively monitor and control their manufacturing environment. From environmental monitoring, sterility testing and media fill results, there is a life connected.

Developing successful oral solid dosage forms necessitates partnering with a CDMO equipped with distinctive technologies and expertise to enable support across solid-state characterization, formulation development and scale-up manufacturing processes.

As the number of highly potent oral solid dose (HPOSD) drugs in development and on the market increases, so are regulator’s expectations regarding their safe manufacture. In this white paper Pfizer CentreOne examines what developers and their manufacturing partners need to know about its unique regulatory challenges and how to navigate HPOSD’s complex manufacturing environment successfully.

Lipid-based formulations (LBFs) and softgels can offer numerous advantages in terms of clinical and commercial potential. Integrating formulation and manufacturing to enhance drug solubility and market speed can help unlock these benefits. Learn more about:

Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up-or scale-down-can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which results in low bioavailability. Lonza has over 20 years of experience in the scale-up and scale-down of spray drying processes. To learn more, read our executive summary.

The increasing number of breakthroughs in small molecule drug development are exciting, but corresponding workflows are complex and require much more tailored approaches to ensure successful upstream and downstream processing, drug approvals and commercialization.

An integrated platform that keeps real-time data in a single location can be a major asset for pharmaceutical companies, as it saves time and money, leading to better quality products and higher profits.

See how Supor Prime filters performed against two comparable products in filtering fluids with antibody concentrations of 70 g/L to 220 g/L. And be sure to request a sample!

The concept of patient centricity is gaining significant traction in the pharmaceutical industry, reshaping the way drugs are developed and produced. This report, developed in partnership with CPHI, specifically explores how optimizing the pharmaceutical supply chain can help improve patient-centricity, and showcases examples of it already being implemented at large. Additionally, the report addresses the increasing role CDMOs and CROs are playing in servicing patients at the end of the pharmaceutical development and manufacturing pipeline.

See how Supor Prime filters performed against two comparable products in filtering fluids with antibody concentrations of 70 g/L to 220 g/L. And be sure to request a sample!

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains. Having a team of individuals with specialized expertise in different areas of clinical supply—including protocol review and early operational planning, to managing the development and execution of a sound clinical supply strategy—can prove invaluable to the overall suitability and performance of the supply chain, and in turn, the successful execution of the study itself.

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client. Additionally, once the CRO has been awarded the project and now must create an executable plan for managing the study’s complex clinical supply needs, there are one or more key decision influencers who are critical to engage early on during the planning and project set-up stage and several proactive steps to take to build a solid clinical supply plan.

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Selecting the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors successfully navigate these challenges.

Standardized manufacturing through a Recipe-Driven Execution environment and digital twins minimizes effort duplication while simplifying operations, harmonizing production processes, and accelerating speed to patient.

QbCon® 1 offers the optimal entry into continuous production. Our truly continuous wet granulator and dryer for research and development guarantees improved product quality while increasing flexibility and operator safety. It also reduces costs by using fewer resources and shortens development cycles by process analytics. Unlike competing systems, QbCon® 1 enables a permanent, truly continuous process without the formation of sub-batches and blocked filters.