Newsletter | June 30, 2020

06.30.20 -- Merck, Walmart, IBM, & KPMG's FDA Blockchain Pilot: Here's What We Learned

 
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What You Need To Know To Avoid Costly Delays In Your API Scale-Up

If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. 

Robotics, Isolators, And Restricted Access Barrier Systems (RABS)

The aim of advanced aseptic processing is the elimination and absolute control of all sources of contaminations — most importantly, human-generated contamination. Robotics and isolator-barrier systems will be the core technologies in meeting this endeavor.

Can You Meet The Diverse Manufacturing Needs Of The Biopharma Market?

Meeting the needs of the modern biomanufacturing landscape requires a combination of technology and digital solutions working together to meet your goals effectively and efficiently.

Embrace Quality Risk Management To Build A Strong Quality Culture
Using quality risk management (QRM) gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.
The Race To Phase 3: A Cautionary Tale Of Scalability

Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

Guidance For Lab Washer Cleaning In Life Sciences

The principal concern for any scientist or technician working in the laboratory is that glassware, instruments, and equipment be free of interfering residues.

Blow-Fill-Seal For Biologics: Breaking Through In Pharma Packaging

As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs. 

Standardization Is Key To Building A Successful Global Business Strategy

Standardized approaches to biomanufacturing can lower costs, improve outcomes, and alter the landscape of the global pharmaceutical market.

Five Tests For Pharmaceutical Containment

As active pharmaceutical ingredients increase in potency and become more hazardous to work with, pharmacological and chemical containment devices are required to meet containment performance targets through independent testing before use in laboratories can begin. Typically, we test containment equipment against some minimum performance standard. This is necessary to protect procedural integrity and the sensitive products undergoing processing.

Serialization And Aggregation Requirements In Russia

Russian president Vladimir Putin signed Federal Law No. 488-FZ, which deals with the amendments to the “Principles of State Regulation of Trading Activities in the Russian Federation.”

Shedding Light On Insulin Aggregation With The Litesizer 500

Formulation of stable protein drugs is challenging, as most proteins are sensitive to sunlight, high and low temperatures, pH, and so on. This application note demonstrates how protein aggregation can be monitored and particle size and mass measured quickly and conveniently by using light-scattering techniques. Furthermore, the transmittance can also provide a very rapid indication of the extent of aggregation.

Comparative TOC Rinse-Up Study Of Pharmaceutical Tubing

Total organic carbon (TOC) content provides a measure of the cleanliness of single-use materials and components considered for use in pharmaceutical manufacturing processes. In this application note, the results of a rinse-up study to measure the TOC from four different tubing types is presented. The silicone tubings were each rinsed with deionized (DI) water, which was then sampled and analyzed off-line to determine the TOC content from each.

Pfizer Installs Feeding Systems For Continuous Manufacturing Operations

A compact arrangement of pharmaceutical feeders supplied by Coperion K-Tron accurately delivers ingredients into the continuous mixing process, guaranteeing consistent and high-quality end products.

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