Newsletter | September 15, 2023

09.15.23 -- Are KRAS Inhibitors Poised To Cure Cancer?


Are KRAS Inhibitors Poised To Cure Cancer?

The KRAS gene, a crucial component of cell signaling pathways involved in cell growth and division, is frequently mutated in various cancers. By targeting the gene, KRAS inhibitors aim to block the aberrant signaling that promotes cancer cell proliferation. Amgen's sotorasib became the first approved KRAS inhibitor, opening up an exciting field.


Accelerating Novel Therapies To The Market

The formulations for novel therapeutics require flexibility to support adaptive sterile manufacturing and an integrated approach for a path from development to small batch manufacturing, to commercialization.

Mitigate Human Error And Improve Performance In Pharma QC

Gain insight into how the quality control team at Almac Sciences developed processes and strategies to help ensure the high quality of safe and effective products while also maximizing efficiency.

Reducing Commissioning Time By 40% With A Digital Twin

Learn how industrial manufacturers are leveraging digital twins to accelerate the commissioning of new equipment and processes, as well as how best to get started with a virtual commissioning program.

PFAS And Biopharmaceuticals: What You Should Know

Here, we share reasons a more scientific approach should be taken to differentiate between the 9,000 chemicals under the blanket categorization of per- and polyfluoroalkyl substances (PFAS).

Four Trends Redefining The Life Sciences Industry

The COVID-19 crisis acted as a catalyst for digital transformation in the healthcare industry. Learn how this transformation has impacted trends and new possibilities in the life sciences sector.

Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems

Discover how USP 1207, the reference standard for container closure integrity testing (CCIT), applies to the CCIT inspection method of intravenous (IV) bags.

Optimizing CDMO Technical Transfer

Learn in detail how a CDMO helps biopharma organizations predict and mediate technical transfer risks before they become costly, time-consuming problems.

Choosing A Spray Drying Manufacturer: Why Flexibility And Customizability Matter

Finding the right manufacturing partner can be a complex endeavor, particularly for companies pursuing therapeutics with complex chemistries or spray-drying needs.

Industry Trends: CDMO Outsourcing

No single CDMO strategy or outsourcing model is appropriate for every project. Outsourcers can and should evaluate a strategy and partner(s) on a case-by-case basis.

bluebird Bio's Scott Cleve On New Therapies, New Regulatory Approaches

bluebird bio's Scott Cleve sat down with the Business of Biotech podcast to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.

Pediatric Dosage Formulation

A biopharmaceutical company known for its successful anti-infective products for adults sought to reformulate the product into an age-appropriate dosage form for young children and preteen patients.

Tailored CMC Solutions To Overcome The Challenges In Fabs And Fc-Fusion Development Programs

Explore an integrated drug substance and drug product CMC strategy, along with technical case studies from process and analytical development that provide insight into tailored product specific solutions.

FAT, SAT, IQ, OQ, SMEPAC: What Does It All Really Mean?

Gain insight into the proper timeline for process validation, the importance of linking the user requirements specification (URS) to each step of validation to ensure complete compliance, and more.

Why And How To Replace Dye Ingress Test By Deterministic CCIT Methods

Understand the challenges and limitations of the blue dye test and compare the sensitivity of the blue dye test to other methods based on a comprehensive study.


Get ready for the most anticipated event of 2023! Join us October 15-18 in Las Vegas, NV, for the 2023 ISPE Annual Meeting & Expo. Experience cutting-edge insights, networking opportunities, and the latest advancements in pharmaceutical engineering. Don't miss this chance to connect with industry leaders and shape the future of the pharmaceutical industry. Register today and be part of a transformative experience!


Space-Saving And Efficient Glass Washers For Superior Cleaning

Reducing Production Waste In Pharmaceutical Manufacturing

Highly Potent Active Pharmaceutical Ingredients (HPAPIs)

How Video Streaming And Wearable Headsets Are Changing Drug Manufacturing

Chemistry, Manufacturing, And Controls Solutions

Complete Monitoring System For Automatic, Continuous Ozone Measurement


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