Newsletter | October 19, 2021

10.19.21 -- COVID-19 Spurs Growth Of China's Domestic Bioprocessing Suppliers

 
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Featured Editorial
Industry Insights
Align Your Chemistry, Manufacturing, And Controls (CMC) Strategy With Clinical Path Requirements And Timelines
Manufacturers must understand the challenges associated with creating a CMC strategy in today’s crowded and diverse market and the expertise and resources needed to successfully execute it.
Sterile Formulation Strategies To Shorten Timelines For First-In-Human Studies

It is important to adopt strategies that create simple but stable formulations for your sterile injectable, thereby establishing a solid foundation for the entire life cycle of your product.

Does Your CDMO Have Sustainable API And RSM Strategies?

How can you be sure the CDMO you select has appropriate oversight and management of their RSM and API manufacturing supply chain, so you do not experience costly delays that disrupt your timeline and prevent your product from reaching the patients who need it?

Top 5 Remote Work And Data Security Risks In Life Sciences

Remote work increases the level of difficulty of proper data governance and security to prevent attacks such as hacks, ransomware, and data carelessness. Read how to mitigate the risks associated with the human side of data governance and information security.

Common Challenges And Solutions Of Equipment Ownership And Use
There are many factors to consider when tasked with acquiring the equipment needed to run a pharmaceutical facility. Being aware of every up-front cost is a must when determining optimal equipment ownership. See how state-of-the-art used equipment can be a great strategy for cost savings for businesses.
Driving Efficiency And Reducing Waste, New Approaches To Sustainable Chemistry Are Greener By Design

When it was conceived by the Environmental Protection Agency (EPA) more than 30 years ago, “green chemistry” was intended to prompt solutions to real-world environmental problems resulting from industrial processes, emissions, and waste. These drivers remain just as relevant now.

Mitigating Risks Associated With Single-Use Systems: Critical Considerations
Single-use systems have become a popular choice to “right size” operations and stay lean. If you plan to utilize a single-use system for your product manufacturing, there are specific factors to consider, all of which play an important role in determining your project’s total risk profile.
Key Considerations: How CDMOs Can Maximize Productivity And Scalability

Urgent demand for new vaccines and treatments has increased the biopharmaceutical industry’s need for resources in a way that requires transformational operational changes. To meet this demand and accelerate the delivery of life-saving medicines, the industry must maximize development and manufacturing efficiencies, as well as increase production capacity, while maintaining high quality and minimizing risk.

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.

A New Way Of Looking At De-Nesting And Re-Nesting Solutions

The emphasis for designing and manufacturing container systems is on container integrity and gentle handling to prevent breakages and product losses. We have developed the innovative, automatic handling unit Nestor to process ready-to-use containers, such as syringes, to and from nests and tubs.

Regulatory Services For Accelerated Development And Commercialization

The increase in breakthrough therapy designations and other allowances for expedited regulatory review has led to ever more innovative drug products being developed under shortened timelines. Learn how to navigate today’s regulatory environment, while shortening timelines to clinical trials and commercialization.

Mixing Cannabis-Infused Products

Gain insights from a pharmaceutical equipment manufacturer on factors that cannabis manufacturers should consider when they're looking to purchase a mixer.

Advancements In Antibody-Drug Conjugates (ADCs) Using SMARTag Technology

SMARTag technology enables site-specific, controlled drug-protein conjugation and uses only naturally occurring modifications to proteins requiring minimal cell-line engineering.

Achieving A Flexible, Integrated, And Sustainable Cryogenic Cold Chain Ecosystem

During this discussion, panelists examine the cell and gene therapy solutions that have been designed to overcome challenges in the cryogenic cold chain ecosystem.

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