Newsletter | November 21, 2023

11.21.23 -- 1 More Year For DSCSA Prep: Pros, Cons, & What To Do Next

SPONSOR

FEATURED EDITORIAL

1 More Year For DSCSA Prep: Pros, Cons, And What To Do Next

The FDA recently announced that they do not intend to take action to enforce drug distribution security requirements under section 82(g)(1) of the FD&C Act until November 27, 2024. What are the pros and cons of this announcement, and what should we do now? This expert shares his perspective and recommendations.

INDUSTRY INSIGHTS

Slide Down The Funnel To Stand Out

Explore the tremendous value of understanding brand position in the biopharmaceutical market and how research into strategic placement, target audience, and more can help companies stand out.

Has Your CMO’s Supply Chain Strategy Evolved In The Scarcity Era?

Organizations of all sizes must employ numerous skillsets to understand a product’s dependencies and levers — upstream and downstream — relevant to a specific supply chain.

Find The Right Construction Method For Your Drug Manufacturing Cleanroom

Compare and contrast the different construction methods available for designing and constructing a cleanroom.

Software Validation In Pharma: Top 5 Challenges

Software validation is crucial in heavily regulated industries such as pharma manufacturing. Learn about software validation in the context of pharma’s top priorities, perspectives, and process pain points.

Key Considerations When Filling Dual Chamber Syringes

Dual-chamber syringes (DCSs) are in high demand across the pharmaceutical and hospital industries. Learn about the challenges of the DCS filling manufacturing market and how to overcome them.

Improving Uptime In Aseptic Processing Of Pharmaceutical Liquids

Maximized uptime, minimized changeover time, and efficient OEE are key factors that have influenced the acceptance of aseptic blow/fill/seal in the packaging of pharmaceutical liquids.

How To Select The Ideal Leak Testing Method For Your Application

We present the pros and cons of electronic leak testing methods and their suitability for different leak detection applications as well as professional advice on selection criteria.

Hydrophilic Interaction Liquid Chromatography (HILIC) Method Migration

See results from an experiment analyzing the USP monograph for cetirizine hydrochloride assay and organic impurities on two legacy HPLC systems and migrating them to the Alliance™ iS HPLC System.

Essential Tubing Connectors For IVD Systems

Find the right tubing connectors for IVD instrumentation, explore a range of connectors, and review how to select and utilize the right tubing and connectors for different applications.

Have You Failed A Design Verification Test For Your Drug Delivery Device?

If a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Learn how to eliminate design verification failure.

Five Best Practices To Ensure Quality Active Pharmaceutical Ingredients

It is important to develop robust, reliable processes to safeguard APIs. Explore the best practices for providing patients with the highest quality of treatment that meets their therapeutic requirements.

Transitioning From Using RUO To cGMP Chemicals For Clinical Trials

Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.

ELISA Explained: From Basics To Practical Application

Explore the four major types of ELISAs (direct, indirect, competitive, and sandwich), how to use ELISA in various applications, and how to effectively choose and utilize these methods.

Integrated Systems For Sophisticated Drug Device Combination Products

Experts discuss the benefits of using integrated systems for sophisticated drug device combination products with multiple device subsystems, and the crucial role a partner can play as a systems integrator.

De-Risking Your Bioconjugate’s Path To Clinical Manufacturing

Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.

Packaging And Containment: Get Your Products To Market Faster

Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.

Engineering Drug Release In EVA Based Implants

Learn about a platform for creating injectable and implantable long-acting drug delivery products, including its technical basics and how it can be used to deliver small molecules, peptides, and biologics.

SPONSOR

Join The Clinical Supply Leader Community

We're excited to introduce a new online community focused on all aspects of clinical supply chain and logistics! Clinical Supply Leader  will help you pinpoint inefficiencies in your supply chain, stay up to date on regulatory changes, identify potential supplier partners, and much more. Sign up for the free Clinical Supply Leader newsletter, delivered to your inbox weekly.

SOLUTIONS

Go Beyond Storage And Distribution

Pinhole Inspector For Glass Vials And Ampoules

Solid Form Services

Cleaning And Disinfecting For Viruses And Other Pathogens

Laboratory High-Shear Mixers

Coated Magnetic Particles For RNA Preparation

LIFE SCIENCE LEADER MAGAZINE

Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.

Connect With Pharmaceutical Online: