Newsletter | January 24, 2022

01.24.22 -- Merck's 2 Lessons On Single-Use Materials

Featured Editorial
Industry Insights
Navigating CMC Requirements For Accelerated Development

Chemistry, manufacturing, and controls (CMC) activities are critical to quickly and efficiently moving promising new drug products to market. Careful planning and early integration of an effective CMC strategy contributes to project success.

Starting Your Sterile Injectables Program Off On The Right Foot

How can drug sponsors and developers leverage these increasingly strategic commercial fill/finish partnerships? Explore tips on how to put programs on a firmer footing.

Is Your API Ready For Scale-Up? What To Demand From Your CDMO

A CDMO that can optimize your API synthesis early during technology transfer will reduce the risk of delay or failure. That will also help your molecule run more efficiently in their plant.

Drug Development From The Patient’s Perspective

Positive outcomes are dependent on the patient’s experience with the therapies we create. How is patient-centricity influencing the therapy development process today, and how will the industry adapt for further patient-centric improvement?

Navigating An Ever-Changing Landscape: The Role Of A CFO In A Private Equity Controlled Pharma Company

The role of chief financial officer (CFO) for a small-to-midsize pharma company controlled by private equity is a challenging one, especially since pharma companies with limited internal resources often rely on CDMOs for support. Learn how these CFOs can use their CDMOs to be more successful.

Lessons In Scaling Lipids Production And Purification

The speed at which the pharmaceutical industry is now developing and manufacturing mRNA drug products at large scale is astounding, yet it has highlighted supply chain vulnerabilities in making the required pharmaceutical ingredients, such as lipids.

Transforming Your Biopharma Automation Capabilities

The seamless functionality of single-use technology equipped with a scalable distributed control system (DCS) empowers you to capture the benefits of collecting and sharing data while simultaneously creating a connected enterprise that grows with the pace of your business.

Continuous Flow Manufacturing Of Pharmaceutical Ingredients

Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

Commercial Manufacturing In Half The Time

Due to U.S. FDA requirements for the commercial manufacturing of regulated (GMP) intermediates, a global pharma company quickly needed a dedicated production facility to produce its commercial antibiotic (carbapenem) intermediate.

The Criticality Of API CDMO Selection: Insights From A Client

Small and emerging companies face significant challenges related to limited funding and resources, making it imperative they find a competent partner to support them. This requires a CDMO that can maintain clear and open lines of communication at every stage.

Zydis Orally Dissolving Tablet (ODT) Provides Better Treatments

Discover how Catalent's oral drug delivery offerings can help get your molecule to market faster. In this case study, learn the many benefits of our product offerings.

Robust, Scalable Manufacturing: N-Linked Glycan Analysis For Complex Glycoproteins

An established cell line and a bench-scale manufacturing process for a complex glycoprotein produced high-quality material but had a low yield and was not scalable.

Post-Discovery Priorities: Streamlining Your Molecule’s Route To IND

Four experts in post-discovery strategy answer questions about critical considerations that impact timelines and commercialization and share insights related to methodologies, robust platform process design, high-throughput automation technologies, optimized workflows, and life cycle approaches.

Find Your Dream Dose Form

To spark your thinking about the right dosage form innovation, meet five high-quality, increasingly popular technologies that may hold the key to your brand’s growth and differentiation.

Outsourced Pharma Content Collections
Your Supply Chain On Inflation: An Outsourcing Analysis

Outsourced Pharma chief editor Louis Garguilo has been an ahead-of-the-curve chronicler of inflation in the development and manufacturing supply chain. Based on interviews with biopharma professionals — from CEOs to frontline workers and consultants — he’s kept readers informed of rising outsourcing challenges, including the price for materials and services at CDMOs and hard-to-find capacity as supply chains remain strained. Now we’ve collected four of Garguilo’s editorials with outsourcing professionals to help you understand what they and the entire industry is experiencing, what you can expect in 2022, and some steps you might be able to take to mitigate these market forces.