Whitepapers

The innovative all-natural lubricant designed to meet growing clean label demands. Developed from rice, this plant-based ingredient is vegan, gluten-free, and offers a sustainable solution for tablet and capsule formulation.

This article presents how the use of robots and automatic loading systems can optimize the terminal sterilization of prefilled syringes.

Do you face challenges when it comes to smaller production quantities, more specialization and many product creations. Flexibility is the answer. With the help of agile systems pharmaceutical manufacturers can overcome these challenges just as easy. Learn how flexible systems bring the decisive advantage to simply switch between the technologies of which you can benefit already in the development phase of solids. The white paper provides information on important approaches to making solids production more flexible and how agile systems can help.

In order to achieve the desired properties in a solid medicinal product, a granulate must be optimally prepared. Did you know that you can have a significant influence on the material properties of your granulate using different granulation techniques? The wet granulation of pharmaceutical granulate mixtures with subsequent fluidized bed drying represents the most important step in the manufacture of solids. But there are other techniques, too. You can find out here which other processes you should know about.

Do you face challenges when it comes to smaller production quantities, more specialization and many product creations. Flexibility is the answer. With the help of agile systems pharmaceutical manufacturers can overcome these challenges just as easy. Learn how flexible systems bring the decisive advantage to simply switch between the technologies of which you can benefit already in the development phase of solids. The white paper provides information on important approaches to making solids production more flexible and how agile systems can help.

In order to achieve the desired properties in a solid medicinal product, a granulate must be optimally prepared. Did you know that you can have a significant influence on the material properties of your granulate using different granulation techniques? The wet granulation of pharmaceutical granulate mixtures with subsequent fluidized bed drying represents the most important step in the manufacture of solids. But there are other techniques, too. You can find out here which other processes you should know about.

Process development methods & analytical requirements are integral parts of gene therapy manufacturing. This whitepaper explores the analytical and development approaches needed for success.

As organizations seek to identify areas where technology can make the most impact, a look at some real-world examples of how artificial intelligence (AI) and machine learning (ML) are being used in highly regulated environments can offer valuable insight.

Responding to the development of more novel therapies and fast-track designations means being equipped with the right processes and resources to support expedited approvals right from the beginning of process development.

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

Annex 1 was released in 2022 and has had an impact on cleaning and disinfection. Download this article for more information on how your facility can stay compliant.

In cleanrooms and other critical environments, it’s important to understand the role that proper wiping technique plays in reliable and consistent contamination control. When cleaning contamination you cannot see, technique is a sure way to know you’ve covered the surface area in question.

Regulatory agencies require pharmaceutical manufacturers to control the environments in which they produce finished products to ensure they are free of contamination. This is a guide to developing an effective cleaning and disinfection program.

Join us for this informative session as expert, Lon Johnson of Colbert Packaging, shares industry insights on serialization and security in packaging – its history, current state, and the oncoming expectations in the war on counterfeit drugs.

In this podcast, Kayleigh Hearse, Sr Mgr. Technical Projects, Capacity Expansion Pharma Production shares details of Baxter BioPharma Solution’s approximately $100 million expansion of its sterile fill/finish manufacturing facility located in Halle/Westfalen, Germany. Kayleigh explains many of the key attributes of the new building, key learnings and major considerations that took place throughout the planning phase.

Read about the process utilized and results gained from the use of a two-phase scale-up strategy to manufacture three complex dry powder medium (DPM) formulations. The success of these projects relied on consistently producing acceptable prototype and cGMP material within the customer’s specifications and manufacturing timelines.

This case study summarizes the outcomes of several media optimization projects and how the results helped manufacturers to achieve their desired scale-up goals, including enhancing productivity, maintaining product quality, and potentially improving return on investment (ROI).

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.

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.