Whitepapers

This whitepaper describes how hot melt extrusion (HME) and a specially-engineered grade of polyvinyl alcohol (Parteck® MXP polyvinyl alcohol 3-82 Emprove® Essential Ph Eur; referred to in this publication as Parteck® MXP 3-82 PVA) can be used to increase the solubility of DCS IIb molecules.

Read about how we helped The Clinician increase users to their website by 85%, new users by 92%, and sessions by 94%

Medical imaging is a key factor in successful clinical trials. At Bracken, our experts bring storied experience from the intersection of medical imaging and clinical research. Our imaging consultants can serve as an intermediary between you and an imaging CRO to launch a complete and accomplished clinical trial.

A robust marketing strategy is key to building brand equity and an effective, efficient sales pipeline—the overall goal. And the best way to develop that all-important strategy is to take stock of where you’re at and assess your resources. To aid in this self-assessment, we’ve developed The Life Science Marketer’s Checklist of must-haves for marketing professionals in the industry. This tool is designed to help you see your areas of strength and pinpoint areas you may have overlooked or have room for improvement.

Biologics—including vaccines, cell and gene therapies, monoclonal antibodies (mAbs), and their biosimilars—have great potential for the treatment and prophylaxis of a broad range of diseases. But, rapid and efficient development of new and effective biologics is no easy feat. With such drastic implications for time and resources, it is imperative that biologic manufacturers choose the right commercial collaborators from the start—agile partners who can improve predictivity, speed, and consistency to bridge basic and clinical research.

When developing a tablet or capsule formulation, three widely used technologies are often considered to produce solid dosage forms: direct compression, wet granulation and dry granulation (including roller compaction). This article discusses why roller compaction is a robust option.

A biotech company focused treatment of advanced solid tumors, partnered with Catalent for the development, clinical trial supply and scale-up of a spray-drying program.

The transition from early phase to late phase of a small molecule program plays a pivotal role in determining a program’s ultimate success. Early planning strategies can help minimize the burdens often faced in that transition. The implementation of modeling tools to analyze the relationships between material attributes, process parameters and product performance can provide an enhanced understanding of the drug product and improve manufacturing efficiency. In this executive summary, experts will demonstrate how Catalent’s (multivariate) modeling tools can help understand the relationship between material Critical Material Attributes (CMAs), unit operation Critical Process Parameters (CPPs) and their impact on the finished dosage. In addition, the experts will explain how these approaches can facilitate in the tech transfer of a program. Lastly, this executive summary includes an overview of Catalent’s oral solid dose turnkey solutions featuring advanced oral solid dosage (OSD) manufacturing technologies and expertise throughout an extensive global network.

Although probiotics are mostly administered in the form of capsules, there are some advantages of tablets in terms of production effort, cost efficiency and stability of the probiotic bacteria. As probiotics are sensitive to high pressure and temperature, it is essential to select appropriate excipients for direct compression to ensure sufficient viability of the bacteria cells during production and storage

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.