Whitepapers

There continues to be a rapid expansion in the orally inhaled therapeutic pipeline, underpinned by scientific, technological, manufacturing and regulatory advances across drug products and devices. In this Q&A article, Catalent experts Carolyn Berg and Carla Vozone discuss innovations in orally inhaled drug products, in particular dry powders for inhalation.

This case study demonstrates scale-up of mRNA supply chain, increased quality standards, and global supply capabilities within record-breaking time.

For a pharmaceutical manufacturer, choosing the QMS that is right for you can be a daunting task. This guide offers a review of the obstacles most likely to hinder a quick, smooth, and effective QMS implementation.

Bachem provides superior quality APIs and meets the high industry standards for achieving successful formulation of microspheres and nanoparticles.

Industry changes, such as shorter timelines and increased product complexity, can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns.

Eurofins BioPharma Product Testing can help eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 trials using our state-of-the-art Vanrx Microcell Vial Filler at our San Diego, CA, laboratory. With flexible scheduling due to small batch sizes and streamlined batch records, we can help you ensure fast delivery to the patient. Learn More about Eurofins BioPharma Product Testing’s sterile fill/finish services.

CPI, a CDMO specializing in Wurster fluid bed coating, has designed and optimized their equipment to create quality coated products.

View this presentation to see how Adare's family of products and services are helping serve special patient populations.

Fluidized-bed granulation nowadays is an integral part of the production of solid dosage forms. In the pharmaceutical industry, fluidized-bed granulation using top-spray technology is a very widely used method. However, the tangential-spray technique is establishing itself as an alternative thanks to the numerous advantages it offers.

Do you face challenges in your scale-up process for granulation? Get your practical tips for successful scale-up for free.

Inclusive medicine removes barriers to clinical trials creating new trial efficiencies that amply science, enabling you to bring treatments to market faster.

This paper presents results from an orthogonal study using isothermal titration calorimetry measurements and biased molecular dynamics simulations.

Connected applications, advanced analytics, and AI have become essential tools in the pharma industry. Go beyond proactive quality management by tapping into your data’s hidden intelligence.

Supply chain woes existed long before the pandemic, and not many scientists want to spend time sourcing ingredients. There is a way to ensure you get the right active pharmaceutical ingredients, at the right cost, with the right plan to scale: partnering with an API procurement and supply chain specialist. Download our white paper to learn five reasons to outsource API procurement.

What if you could rely on one partner to source APIs, formulate and develop drug products, and manufacture at clinical and commercial scale? Rather than too many links in your supply chain, an end-to-end CDMO reduces layers of administration, gaps in knowledge, time, cost, and risk. Download our white paper to learn the five “must ask” questions to find the right CDMO.

When the patent on a brand-name dental paste expired, our client saw an opportunity to offer sufferers of painful oral lesions a generic alternative. Their product would drive down costs for patients while positioning the client’s business for success in a competitive market. With the FDA’s Abbreviated New Drug Application (ANDA) regulatory pathway leading the way forward, all they needed was a partner with experience developing and manufacturing unique semi-solid products. That’s when they found LGM Pharma. Read our case study.

This white paper from outlines the best steps to establish an efficient drug formulation development process to stay within budget and meet timelines. 

Effectively adopt and integrate CPV into existing production processes to optimize the increasingly pervasive continuous manufacturing ecosystem.

Large volume parenteral applications are characterized by high volume doses of a drug product, which are administered intravenously. Flexible bag systems, which contain a combination of different materials, are often used as container/closure systems. Definitions and regulatory requirements for extractables and leachables testing of large volume parenteral products, will be highlighted. Next, typical sources of extractables and leachables in flexible bag systems for parenteral use will be listed. Emphasis will be put on the specific challenges associated with large volume parenteral applications. Finally, some case studies regarding different designs of extractable studies will be discussed.