Newsletter | January 12, 2022

01.12.22 -- Biopharma CEO Requires Close Relationships And Recruiting At CDMOs

From The Editor
Featured Editorial
Industry Insights
Achieving Large-Scale Ophthalmic Production

Ophthalmic treatments require a manufacturing partner with the expertise, quality assurance practices, and modern equipment necessary to ensure a safe, effective drug product.

Crystallization Of Challenging Pharmaceutical Targets To Aid Drug Discovery

Discover a few successful strategies used when growing crystals of challenging pharmaceutical targets to aid drug discovery and two case studies performed by an experienced team of crystallographers.

Analytical Considerations For Biopharmaceuticals During Commercialization

As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

In Vitro Dissolution Methodologies For Amorphous Solid Dispersions

With the availability of so many types of in vitro dissolution tests, how do you determine which one will be most effective in predicting in vivo performance of your Biopharmaceutical Classification System (BCS) II or IV drug product?

Considerations When Outsourcing Your Packaging Operations

In this Q&A we dig into some of the essential elements our experts identify as key to maintaining and enhancing both existing and new partnerships. Learn how outsourcing this key aspect of bringing product to market can benefit your organization and overall supply chain optimization.

3 Steps To Optimize The Fed-Batch Process For Monoclonal Antibody (mAb) Production

We describe a straightforward way to achieve a high-performing fed-batch process for a knockout cell line. This workflow improved titers 500% compared with Chinese hamster ovary (CHO) cell culture in basal medium.

Principles Of Raman Spectroscopy And Application To Pharmaceutical Development

Discover how Raman spectroscopy is used to analyze a chemical compound’s structure and an example of how this technique is used to analyze amorphous material created through a hot melt extrusion process.

CDMO Collaboration: Foundation For Sterile Injectable Product Success

Explore how a small or midsize biotech or pharma company developing sterile injectables can benefit from the experience and assistance provided by a CDMO.

Challenges Of Moving A Bioconjugate Candidate From Clinic To Market

Drug developers must successfully navigate the path to market, under the growing pressure of regulation and competition, and while carefully managing technical and financial risk.

Orphan Drugs: Balancing Financial Incentives And Complex Challenges

Whether your orphan drug is a small or large molecule, there are key strategies to enable a seamless transition from early development into commercial manufacturing, while also balancing your investment.

Development And Manufacture Of Biopharmaceuticals Produced In Microbial Systems

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. We also discuss considerations for an early process development strategy that helps plan a program with the end goal in mind.

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.