05.02.24 -- FDA Final Guidance: Reporting Listed Drug Amounts

Dive into the biopharmaceutical realm, where the synthesis of biologically derived APIs encompasses cell line development, fermentation, and sophisticated purification techniques. Outsourced Pharma Capacity Update’s new PARTNER WEEK will include a session featuring CDMOs with capacity for meeting the production demands of your Large Molecule Drug Substance and Development projects. Join this digital event happening May 21st.

Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.

Review the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver tomorrow’s medicines in a safe, compliant, and efficient manner.

Leveraging a CDMO's experience with sterile injectable product development and manufacturing, as well as maintaining transparent communication, is essential to ensuring a successful product launch.

Innovative solutions allow you to conceptualize and implement accelerated paths to compress processes while minimizing risk and ensuring product quality.

It is essential for biopharma companies to stay up to date on the future of CDMOs. Read about three key trends that are helping shape the CDMO industry.

The main challenges associated with the first clinical supplies of an aseptic drug product fall into one of three categories: formulation, fill/finish, or post-production.

Explore how MAPPS demonstrates promise as a valuable tool for comprehensive immunogenicity assessment in therapeutic protein development, contributing to safer and more effective biologics.

Review advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.

An experienced contract manufacturer can help developers better utilize internal resources, leverage industry experience, and mitigate risk across development cycles.

To support fast-track clinical programs, CMC professionals in early-stage biotechs find themselves behind the eight ball. Start-ups overestimate their understanding of the scope, complexity, and impact of CMC. They then rely on CDMOs to assist with arbitrarily decided clinical start dates. Outsourced Pharma Live is here to offer remedies for all this pushing a program into and through the clinic, and for effective utilization of CMC operations. Register today!

Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Review a holistic approach to DP development that anticipates and prevents problems early.

Examine how the earlier your CDMO is able to understand your process, the better prepared it will be to support development and clinical or commercial manufacturing.

BD Neopak XtraFlow Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.

At AGC Biologics, we have developed over 200 mammalian, bacteria and yeast-based processes, giving us the insight necessary to identify and optimize process parameters that are critical for achieving a high-quality, cost-effective manufacturing process.