Newsletter | April 6, 2021

04.06.21 -- A Risk Assessment Checklist Of Nitrosamine Impurities In Oral Solid Dose Drugs

Featured Editorial
Industry Insights
Science Of Scale For Spray-Dried Intermediates

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.

What You Need To Know To Avoid Costly Delays In Your API Scale-Up

If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. 

COVID-19's Impact On Outsourced Manufacturing

The unpredicted need for billions of doses of a vaccine sent tidal waves through the industry, derailed strategic plans set in place years ago, and forced pharma companies to shift resources.

What Is The Status Of Drug Intellectual Property (IP) In Taiwan?

One of the biggest concerns about working in Asia by North American drug companies is the sanctity of their intellectual property (IP).  Will it be copied, and years of time and money invested lost? 

Innovative Approach To Process Development

The key to the successful development of safe, efficient, and cost-effective API production-scale processes is the application of smart chemistry and process development principles.

How To Increase Solubility And Bioavailability With Hot Melt Extrusion

When executed properly, hot melt extrusion (HME) advances poorly soluble compounds in the development pipeline, without adding delays, cost, or significant post-processing activities, and can scale to commercial manufacturing.

The Demand For Flexible Aseptic Filling And Isolation Systems

This document provides information on the latest status, trends, and technologies in parenteral filling equipment.

Lung Cancer Treatment By Inhaled Formulations

This article describes formulation and manufacturing considerations for the development of dry-powder therapeutics and a case study where an approved drug is successfully formulated.

A Tale Of Two CDMOs: Which Choice Will Your Biopharma Make?

Today’s growing biologics challenges make the choice of a CDMO critical. You need a trusted and experienced partner, from DNA sequence to commercial launch, and at each checkpoint along the way.

How To Select An API Partner For Strategic Success

A strategic partner should always seek ways to innovate and improve your compound or product’s value, and do it with the dedication of a partner, not a supplier. 

Responding To Market Trends In Prefilled Delivery

As the industry continues to see significant growth for drug products developed in prefilled syringe (PFS) technologies, there is a trend to evaluate more complex drug molecules that require delivery systems. 

Can You Afford Not To Outsource Buffer Preparation?

The decision whether or not to outsource buffer preparation is not clear-cut, but it provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.

Lessons Learned Executing A Closed And Connected mAb Process

Read our recommendations from our execution of a closed and connected monoclonal antibody (mAb) process, from design considerations to scale-up, including the small-scale modeling that directed our process at scale.

Nutritional Medicine Manufacturer Installs Two-Lane Checkweigher

Orthomol pharmazeutische Vertriebs GmbH develops and markets an extensive range of food supplements. A new two-lane C35 AdvancedLine checkweigher excels in accuracy and throughput.

Sterile Parenterals: How To Protect Oxygen-Sensitive Formulations

This e-book describes how to protect oxygen-sensitive formulations, covering methods for in-process monitoring of oxygen, nitrogen purge optimization, and validation of data for a manufacturing filling line.

Capture OTC Market Share For Geriatric And Pediatric Patients

This webinar discusses how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations. 

A Faster Path From Prefilled Syringe To Auto-Injector

This on-demand webinar covers how to transition your self-administration product from prefilled syringe to auto-injector faster with an experienced partner who can anticipate equipment and process needs.

The Rise In Single-Use Containment For CMOs

The on-demand webinar CMO/CDMO Facilities Gain Value with Single-Use Containment presents a case study for an oral solid dose (OSD) process, shared facilities, and HBEL/ADE requirements.

How Robotics Answer Today’s Pharma Manufacturing Challenges
What are the COVID-19 effects on pharmaceutical manufacturing? Can we expect “onshoring” strategies following the crisis? Is the general opinion about robotics improving? Watch this webinar to learn more about where and how robotics add value and solve problems.
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