Newsletter | January 7, 2025

01.07.25 -- Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides?

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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

How To Establish Effective, Scalable Drug Safety Ops Across Vendors

Numerous factors impact a drug safety program, but proper management of three key elements drives success while creating a scalable drug safety model.

Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives

A gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.

Reshoring A Nation's API And Pharmaceutical Production

A variety of concerns — underscored by supply chain disruptions driven by the COVID-19 pandemic — are pushing companies to redraw global supply chains to resume more domestic manufacturing.

Optimizing Chromatography Media In Bioprocessing

How can you optimize your media for chromatography and improve consistency, yield, and purity through the integration of automation technologies such as advanced slurry preparation systems?

Optimizing Formulations With Bioavailability Enhancement Technologies

API-sparing development techniques and identifying the appropriate scalable formulation technology to improve drug solubility and enhance oral bioavailability can help increase your chances of success.

What Changes When Your CPV Goes Digital

Gain insight into the advantages of digitalizing Continued Process Verification (CPV) through the experience of a pharmaceutical company step-by-step.

Early Preclinical Development: A Successful Transition To Manufacturing

Explore the development steps that lead to an mRNA construct optimized for your requirements and that meets future-proof cGMP manufacturing requirements, thereby de-risking the development.

Leading Biopharma Increases The Efficiency Of Aliquoting Process

A leader in the biopharmaceutical industry collaborated with Sartorius to improve the efficiency of their CAR-T cell therapy media preparation. Discover their aliquoting solution.

Why A Leading Manufacturing Partner Chose NeoTOP Packaging Machines

Learn how a leading CDMO partnered with Körber to quickly deploy a high-speed packaging solution to meet tight production deadlines in the face of a global pandemic.

FEATURED EDITORIAL

Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides?

Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.

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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

Level Up Your Data With Data Intelligence Software

Nasal Dosage Form Development

An Active Air Sampler For Multiple Applications

PBPK Predictive Modeling Services

Pinhole Inspector For IV Bags And Flexible Packaging

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