Newsletter | October 13, 2020

10.13.20 -- A Quality Agreement Primer: Managing Risk When Working With Contractors

 
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Transportation Solutions For Cell And Gene Therapy Supply Chains

Developing a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.

Complex Parenteral Drug Manufacturing: A Foundation For Success

Developing and manufacturing complex parenteral drugs is one of the most difficult processes in the pharmaceutical industry. Successful drug manufacturing is built on a solid foundation of skilled professionals, quality systems, and comprehensive risk management.

How To Minimize Production Downtime By Maintaining Your Tablet Compression Tooling

Optimizing and maintaining tablet compression tooling surely brings challenges. Poorly performing tools are a challenge all pharmaceutical manufacturers must conquer. This blog reviews how to reduce common compression issues during production and eliminate tooling downtime, and offers tips on how to extend the life of your tablet compression tooling.

Is Your Biologics At Risk For Protein Aggregation? Part 2

How to prevent protein aggregation via considerations for the manufacturing process and container selection criteria. Part two of a three-part series.

Security Of Supply In Cell And Gene Therapy Manufacturing

With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.

Technology Selection For Bioavailability Enhancement

Due to the growing incidence of low drug solubility in the pharmaceutical discovery and development pipeline, the number of enabling technologies that are employed to improve oral drug absorption and bioavailability (BA) are growing. Rational selection methodologies across this array of technologies can improve chances of clinical success, reduce program complexity, and accelerate development timelines.

The 3 Cs You Should Expect From Your Pharma Service Provider

When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.  

Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product
Thermo Fisher’s stepwise approach to quality by design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign.
The Value Of A BD Integrated System For Combination Products

The growing complexity and regulatory rigor of combination products has called for increasingly innovative delivery devices. This article looks at the advantages of using an integrated system for these drug-device combination products, rather than sourcing components from different suppliers.

How To Implement Cleanroom Upgrades While Operating Your Facility

It goes without saying that upgrades during a manufacturing shutdown pose less risk as there are no products being produced, but there are instances when it is critical to expand capacity or modify functionality while maintaining some processing. Following are steps to follow to help maintain control of production and changes while keeping the involved workers and the products safe.

Are You Guilty Of Under-Using And Under-Investing In Your Most Valuable Resource?
Larger pharma organizations have evolved into hierarchical silos due to a combination of legacy organizational structures, mergers and acquisitions, and lack of a holistic approach to innovation.
Using Lipid Formulations To Enhance Bioavailability In Early Development

Lipid formulations offer an easily scalable approach that can cut timelines and considerably reduce costs during development and commercial manufacturing. To prevent delays and costly issues during the development of these molecules it is important to understand what potential mechanisms of increased absorption with lipid formulations and appropriate screening tools are available.

The Importance Of An Analytical Testing Strategy For Combination Products

As combination products evolve, and a preference for self-administration systems such as prefilled syringes, auto-injectors, and pen injectors commercialize, there is a need to ensure proper testing of both the primary and secondary components in compliance with regulatory guidelines. 

Indirect And Direct Loading Of Pharmaceutical Blenders Via Vacuum Conveying

Vacuum loading of blenders typically falls into two categories: indirect loading via pneumatic sequencing systems or direct loading, where the blender becomes the primary vacuum receiver.

Perfusion: Best Practices For Evaluating A Perfusion Medium

By using a perfusion process, cell density and product titer can reach higher levels than is possible with a conventional fed batch process. Selecting the right medium requires thoroughly knowing your process goal, test model, and cell line. It also means understanding not just what you are testing, but what you are not testing. This informative ebook from Gibco will help get you started on your path to perfusion success.

Highly Potent APIs Are Becoming More Potent And Complex

Dr. Andreas Meudt is the global head of exclusive synthesis for Evonik, one of the world’s top three CMOs for APIs and the largest for highly potent APIs (HPAPIs). In this interview, Dr. Meudt shares his thoughts on key growth trends for HPAPIs and why more pharma companies are outsourcing their production to contract specialists.

How To Effectively Manipulate Highly Potent Products In The Pharmaceutical Industry

This online event will give you the opportunity to gain insight on process innovation, occupational health and safety questions, and appropriate technologies available today to overcome the many challenges in high containment manufacturing facilities. The handling of HPAPIs is a highly complex process and calls for sophisticated equipment and process isolators. Dec offers comprehensive solutions for R&D teams to production plants.

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