Newsletter | September 13, 2021

09.13.21 -- Surprise! CEOs Select CDMOs

 
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From The Editor
Featured Editorial
Industry Insights
What Is The Difference Between Verification And Validation Of Analytical Methods In The Pharmaceutical Industry?

For a contract manufacturer, one of the first steps in evaluating a technology transfer project is asking this question: Do we need to perform analytical method verification or method validation? Although method verification and method validation look similar, they are not the same and they have different requirements.

Five Dangers Of An Insecure API Supply Chain

The diversity and agility of API supply chains are key to ensuring that medicines can be manufactured and delivered to patients on time, even in the face of challenges and unforeseen circumstances.

Optimize Your Lyophilization Process Using Minimal Drug Substance

Here's how advances in steady-state computer modeling and bench-scale lyophilization practices are driving process optimization with minimal drug substances.

Effectively Managing Data In Process Development

Addressing data management challenges during drug development requires an understanding of today’s shortcomings and the factors to consider when adopting a solution to overcome them.

Continuous Or Batch: The Best Solution For Your Oral Solid Dose Product

Gaining a better understanding of continuous manufacturing and its fitness for your oral solid dose (OSD) product could secure more control over the quality and safety of your product and, ultimately, the future of its success.

Transitioning From Vial To Prefilled Syringe: How Formulation Development Affects Manufacturing

Understanding how formulation development for a prefilled syringe affects manufacturing can drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Lung Cancer Treatment By Inhaled Formulations

Dry powder inhaled formulations hold promise to allow local treatment of lung cancer with decreased chemotherapeutic-related side effects. Explore the formulation and manufacturing of a topotecan inhaled dry powder and its use in decreasing tumor size in an animal model.

Illustrating A Successful Small Biotech-CDMO Relationship

In this article, Levicept founder and CEO, Simon Westbrook, discusses his experience in selecting and working with a global CDMO partner, and the value Lonza brought to his virtual company, which he established to develop the molecular design and process development for a complex protein he had begun working on while at Pfizer.

The Shift Toward U.S. Pharmaceutical Manufacturing

The pandemic has brought the global interdependency of pharmaceutical supply chains into sharp focus, exposing weak links and reigniting discussions around the value of reshoring production. Explore effective strategies to secure and de-risk pharmaceutical supply chains.

Validation Accelerated

The challenge: A major pharma company’s need for scale-up and validation of a cGMP intermediate had been delayed for a while when the U.S. FDA suddenly granted it priority status.

Transforming From Supply-Led To A Demand-Led Model To Support Commercial Gene Therapies

In gene therapy supply chains, the focus is entirely patient-centric, and the ‘volumes’ can often be as low as one dose per batch/lot, so the supply and distribution model needs to be much more flexible and precise.

There May Be Dragons: Mapping 7 New & Emerging Pharma Development Risks

With complex modern molecules you’re likely to encounter unexpected risks and challenges that may threaten your plan’s resilience. Identify key risks in drug development and clinical services — and build a plan to overcome them.

A Complete Guide To Aseptic Manufacturing

Aseptic manufacturing is a uniquely challenging process that requires expertise and careful planning for successful execution. Gain valuable insights and guidance on aseptic manufacturing, sterile fill/finish, and its supporting activities.

Softgel Technologies Overview

Innovative softgel technologies that maximize your market potential: Where ideation and expertise come together.

Coating: Curing Your Complex Oral Solid Dose Challenges

Pfizer CentreOne’s oral solid dose experts discuss how advances in the mathematics and engineering involved in understanding the process can tackle challenges and ensure that functional coating and drug layering continue to be a viable solution for the next generation of oral solid dose (OSD) drug products. Discover how coatings expertise could transform your OSD drug.

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Advanced Therapy Conundrum: Should You Build, Outsource, Or Go Hybrid?
 
Companies developing advanced therapies must decide early on: Build capacity, and how much? Outsource, and how little? Mix and match, and how effective? Fortunately, there are guiding principles and best practices for getting these individual assessments right.