Newsletter | January 17, 2022

01.17.22 -- Defending Your Supply Chains From "Foreign Suppliers"

From The Editor
Featured Editorial
Industry Insights
A Streamlined Process For Confidentiality Disclosure Agreements (CDAs)

Disparities in CDA templates, out-of-date language, agreements involving more than two parties, and difficulty in gathering necessary signatures all can derail this critical process.

Mechanistic Modeling For Downstream Processing: Digital Twins Are Here To Stay

Expensive and time-consuming laboratory experiments, iterative empirical optimization, and even statistical methods alone are not the answers to the challenges of the future. Many global biopharma companies are working on establishing digital twins of their upstream or downstream processes.

Evaluating Current Manufacturing Platforms For Recombinant Adeno-Associated Virus (AAV) Production

Realizing the full potential of viral vector-based therapies requires an understanding of the platforms currently available for recombinant AAV production as well as how to properly evaluate them.

Innovating In The Viscosity Design Space For Handheld Combination Products: A New 2.25 mL Autoinjector Platform

Discover an autoinjector platform that reconciles the demands of biologics with safety, reliability, and ease of use during self-injection.

Technology Transfers: A Beginner’s Guide

You may have questions and knowledge gaps on technology transfers. This beginner’s guide covers the basics and the three key phases of technology transfers.

Advantages Of Working With An Embedded CMO
With specialized resources and facilities, backed by a wealth of expertise, the right CMO can expedite market launch for the timely delivery of essential drugs to the patients who need them most. An embedded CMO offers many advantages over other CMO models, not least being its access to the extensive capabilities and know-how of the parent organization.
Project Management To Meet Today’s Drug Development Challenges

Gain insights into the steps CDMOs can take to streamline project management to benefit the small and emerging biotech companies they work with.

Comparison Of Raman And Midrange Infrared (MIR) Spectroscopy For Bioprocess Monitoring Of Mammalian Cell Cultures

As both Raman and MIR spectroscopy measure in the molecules’ so-called fingerprint region, they can detect similar analytes but with differing sensitivities. A direct comparison between the two technologies was conducted to investigate which system is more suitable for analyzing mammalian cell culture(s).

Avoid Common Pitfalls When Outsourcing Your Fill/Finish Project

Any errors during the fill/finish stage can delay clinical trials or even prevent meeting funding milestones. Be sure to avoid these four common pitfalls when outsourcing your fill/finish project.

Exploring Best-Practice Manufacturing Strategies For Highly Potent Oral Solid Dosage Forms

As the number of highly potent oral solid dose (HPOSD) drugs in development and on the market increases, regulatory expectations continue to evolve. Review the regulatory considerations for today’s HPOSD products.

Six Principles For Getting Pharma Development Right From The Start

This paper highlights six keys that pharma and biotech companies should keep in mind when selecting a partner to synthesize an API to ensure the development process tracks toward success.

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.

Embrace Molecule Complexity With Optimized Expression Technologies

Explore the needs of more complex candidates through case studies that demonstrate the range of expression capabilities across mammalian and microbial derived molecules.

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.