Newsletter | March 14, 2025

03.14.25 -- EMA On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety

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Explore how shifting demand for oligos and peptides is driving outsourcing relationships and innovation in CDMO partnerships. Join our next Outsourced Pharma Live as we cover best practices for outsourcing these specialized therapeutics, focusing on capacity, regulatory challenges, and technology transfer. Register today to learn about the unique challenges and opportunities in scaling production for these complex molecules.

INDUSTRY INSIGHTS

Understanding Technology Transfer In Pharmaceutical Contract Manufacturing

Technology transfer is a crucial process in the pharmaceutical industry, ensuring drugs developed in labs can be manufactured consistently at scale.

Spray-Dried Dispersions Enable Local Delivery For Lung Cancer

Learn more about spray drying, and explore case studies detailing its success as a critical tool in developing innovative and effective lung cancer therapies.

CMC And Clinical Strategies For Developing Injectable, Oral Peptide Drugs

In this session, Chief Scientific Officer Dr. Andy Lewis delves into the key drivers shaping peptide drug development and explores innovative delivery options to enhance therapeutic outcomes.

Strategic Space Management

A pharmaceutical company facing storage space issues decided to outsource its reference samples to Q1 Scientific, a stability storage service provider, resulting in cost savings.

The Paradigm Shift To Continuous Flow Processes: A Holistic View

Dr. Bert Metten, Tech. Dev. Manager at Ajinomoto Bio-Pharma Services, explores dangerous chemistries and continuous flow processes for the manufacture of safe, efficacious, cost-effective products.

FEATURED EDITORIAL

EMA On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety

There has been limited guidance for assessing new or elevated impurity levels. To address this, the EMA has issued a "reflection paper" to consider what is needed for a safety evaluation and how to make assessments. The public comment period ends April 30.

More AI But Fewer Process Chemists?

Artificial intelligence (AI) has made its way to the midsection of our new-drug life cycle, now enabling route-scouting and data scientists at drug sponsors and at your CDMOs. What does this look like in practice? Will there be fewer process chemists in the future, and who will they be?

SOLUTIONS

Process Development And Preclinical Manufacturing — India

Our innovative business model won't add additional costs to your project. Check out our network's process development and preclinical manufacturing capabilities to simplify your outsourcing solutions.

Comprehensive Regulatory Support In New Zealand

Review our expertise across a wide range of global markets. Our experience in securing regulatory approvals and navigating market challenges positions us as a trusted partner.

Over-Encapsulation/Blinded Study Materials

If the material is not adequately blinded, clinical trial participants may be able to tell the difference between the real drug and the placebo, resulting in a biased trial and a loss on your investment.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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