Newsletter | January 3, 2025

01.03.25 -- Stage 3a: A Key Indicator For Process Validation Maturity

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Webinar: Quantifying and Assessing Cleaning & Disinfection Residues: A Case Study

This presentation reviews the impact of cleaning and disinfectant residues in ATMP cGMP manufacturing, focusing on their risks and management. It addresses how Annex 1 revisions highlight the need for better residue control, offers methods to quantify residues beyond visual inspection, and discusses designing effective cleaning regimes. Click here to learn more.

INDUSTRY INSIGHTS

The Importance Of Operator Equipment Training

Learn why a strong commitment to operator training is essential to prevent production issues, ensure product quality, and safeguard patient safety.

Industrial-Scale Organoid Production: Challenges, Advantages And Solutions

Organoids, 3D models replicating human organs, are a growing topic of interest for researchers as they offer invaluable advantages, but come with several challenges.

An Executive's Checklist For CDMO Selection

Executives must take an early and active role in vetting potential partners, using a deeper understanding of the capabilities a CDMO should have to successfully bring a product to market.

Identify Lead Solid Form Early To Reduce Timelines And Downstream Costs

Devoting early-phase resources for solid form understanding and screening during a drug’s development lifecycle is critical, as doing so can help save time and resources on the path to market.

Developing Injectable Drug Placebo Formulations For Clinical Trials

Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.

Peptide-Based Therapeutics: Innovative Technologies To Develop And Scale

Watch as industry experts walk through a variety of technologies and case studies, focusing on LPPS, peptide crystallization, method development for peptide impurity analysis, and more.

Primary Packaging Solutions For Emerging Innovators

If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.

Making A Difference For Life Science Manufacturers

Explore the value of an ideal solution for manufacturing drug substances, drug products, intermediates, and other life science products—specifically designed to streamline processes and elevate quality.

Systems And Software For Compliant Serialization And Aggregation

This track and trace workflow illustrates the many moving parts involved in production and where two software solutions can be integrated into your systems and processes to maximize efficiency.

Best Practices For The Design-Build Of Hot Cells, Isolators, And Gloveboxes

Here, we address a number of OHS, regulatory, and process requirements imperative to the delivery of critical containment systems.

FEATURED EDITORIAL

Stage 3a: A Key Indicator For Process Validation Maturity

Process validation's stage 3a serves to reconfirm the assumptions made during design space development and is particularly pronounced for new modalities and emerging processes.

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The peptide market is booming, driving manufacturers to enhance processes and capacity. What key changes are shaping peptide manufacturing? How can continuous manufacturing boost efficiency and meet demand? Don’t miss our inaugural Pharmaceutical Online Live digital event on January 22nd. Registration is free thanks to the support of Federal Equipment Company.

SOLUTIONS

Formulation And Manufacturing Equipment

Integrated Operations Produce Top-Tier Raw Materials

Laboratory High Shear Mixers

A Comprehensive Approach To Cleaning And Disinfection

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