03.04.24 -- FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

In addition to discussing how to implement Maruno’s method of analysis to identify various fill states in AAV preparation, we’ll also cover the utilization and technical limitations of other techniques, such as analytical CsCl density gradient analysis and SEC-MALS, for characterization of AAV samples. Click here to learn more.

In an example using rituximab and its biosimilars, explore the significance of differences in glycosylation in antibodies and its impact on their properties and functionality.

Review the needs of more complex candidates through case studies that demonstrate the range of expression capabilities across mammalian and microbial-derived molecules.

Examine the potential of the FDA and NIST's MOU to provide critical technical guidance that could greatly standardize the approaches to implementing AMTs, such as those used in continuous manufacturing.

A quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

The dual specificity of BsAbs opens a wide range of applications. Understand why consistent production of structurally complex molecules that exhibit high yield and purity requires keen expertise and experience.

When it comes to outsourcing drug development and manufacturing, are consultants important? Explore the role of consultants and industry trends that influence their relationships with organizations.

Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.

Understand how a CDMO with a commitment to quality and decades of experience can help overcome development hurdles and bring your treatment to patients in need.

Expedited regulatory pathways are being used more often, even as small molecule pipeline candidates grow in complexity, creating new risks for drug developers. Join Outsourced Pharma Live March 14th for a discussion with small molecule biopharma executives on the key considerations for CDMO selection, pitfalls to avoid with service providers, and tips for getting to the next development milestone.

Explore how our proven expertise and simplified execution with development, filling, and analytical under one roof ensures that safe, efficacious products reach patients in need.

We offer sampling and dispensing services for clients who store bulk API, excipients, and other ingredients in our storage facilities.

Our unique expertise enables us to express a variety of molecule types. Using scalable, high-density microbial fermentation, our clients benefit from shorter development at each phase and subsequently lower cost.

A small biotech developing precision medicines was seeking to develop a monoclonal antibody called CPI06, now known as Mupadolimab. Learn more about the biotech’s experience with Lonza.