Newsletter | February 19, 2025

02.19.25 -- Regulatory-CMC: A Core Practice For Successful CDMO Partnerships

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FEATURED EDITORIAL

Regulatory-CMC: A Core Practice For Successful CDMO Partnerships

Regulatory-CMC is the denominator through the career of Sai Prathyusha Bhamidipati, currently at Moderna. Regulatory-CMC focuses on ensuring compliance with regulations regarding the production and quality control of your pharmaceutical products. Bhamidipati explains the importance for the practice of which when dealing with CDMOs.

These Were FDA's Top Citation Issues For Data Quality In 2024

Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.

INDUSTRY INSIGHTS

Continuous Manufacturing: An Evolving Technology For Drug Manufacturing

Explore the exciting developments in continuous manufacturing and see how leveraging this innovative technology can help improve manufacturing processes and discover new clinical candidates.

How T3P Is Helping To Advance API Development

Uncover how innovative reagent selection accelerates the development of promising drug-like molecules in challenging research environments.

The Development Of Nanosuspension Formulations For Poorly Soluble Drugs

Learn about key topics in nanomilling, including practical applications and advantages, specialized equipment, milling media, stabilizers, as well as manufacturing and scale-up considerations.

Pharmaceutical Spray Drying – Technology And Applications

Discover the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.

Designing Shelf-Stable, Dry Powder Vaccines To Improve Global Access

Spray dry technology is being leveraged to create shelf-stable, dry-powder vaccines to treat and prevent the spread of tuberculosis which could significantly improve our global response to disease.

Developing Assays For Insulin Analogues And Other Large Peptides

Here, we explain how a physicochemical-based approach can help accelerate the bioanalytical assay development for insulin analogs, avoiding delays and increasing efficiency in clinical trial processes.

SOLUTIONS

Automatic Pharmaceutical Capsule Filling System: NCF-45

The Natoli NCF-45 Capsule Filling Machine offers unmatched speed, precision, and versatility for efficient powder and pellet encapsulation, maximizing your production output and minimizing waste.

Link Your Antibody To Its Fullest Potential

Our parallel development service works seamlessly with our existing antibody capabilities, all under one roof, to ensure we meet the needs of our clients and help them reach the market faster.

R&D And Analytical Services

Receive experience, efficiency, and technical proficiency from our team of analytical experts in the development/validation of analytical methodology and GMP testing support for your project.

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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