Newsletter | January 4, 2024

01.04.24 -- WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development

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Webinar: Quality Roundtable — Optimizing Biologics Manufacturing Processes With Raw Materials

Join this roundtable of regulatory and raw material experts as they discuss navigating important quality decisions associated with raw material selection throughout the biologics manufacturing process. Get your questions answered on how to help drive the most efficient regulatory submission and review during your development journey from preclinical to licensure. Click here to learn more.

FEATURED EDITORIAL

6 Principles For An AI Regulatory Framework For Product Development

In mid-October 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for AI should address and are starting to coalesce around.

INDUSTRY INSIGHTS

Gliding Toward De-Risked Combination Product Development

Learn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.

Recombinant Proteins: Understand 5 Key Process Development Challenges

Once a company has demonstrated proof of concept, it is critical to consider process elements such as scalability, sourcing raw materials, and GMP adherence.

Choosing The Right Pharmaceutical Containers For Your Needs

Choose the right pharmaceutical container for your powder transfer process following basic rules and guidance to determine which size container you need.

Validated HPLC-UV Method For Quantification Of Paxalisib

Examine research into the development and validation of an HPLC method for the quantitation of paxalisib in mouse plasma and its potential use for routine therapeutic drug monitoring.

Intensifying A mAb Polishing Platform

We demonstrate how a mAb purification batch process can be converted into a stepwise intensified batch process, successfully eliminating intermediate steps and achieving over 13% cost reductions.

Giving Production A Powerful Boost Through Digital Inline Printing

Gain insight into how technology is helping Recipharm in Pianezza reduce aluminum foil consumption in blister production by 30 percent while maximizing efficiency.

Media And Feed Development: A Guide To Workflow Optimization

Explore each development stage as well as best practices that will help achieve your project goals on time and within budget.

Utilizing Nanoparticle Technologies For A More Sustainable Value Chain

The pharma industry is identifying new ways to make processes more sustainable. See how nanoparticle engineering technology can both empower sustainability goals and lead to better patient outcomes.

Optimizing CMO Partnerships

SMC experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.

Expressing Next-Gen Immunotherapies And Other Advanced Biologics

Discover how the GS Gene Expression System and cell line engineering technology can rise to the challenge of producing novel IgG-engineered cancer immunotherapies.

Biological Indicators: Identification And Purification

In this session, an expert walks you through the purity testing process and explains identification methods for biological indicators to help end users.

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.

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High-Speed In-Line HVLD For Prefilled Syringes

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