06.15.22 -- Breaking Down The CDMO Size Barrier

As the field of biologics increases its focus on identifying new diseases to target and novel constructs to treat them, innovative administration devices are once again in the spotlight.

Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

Despite advantages, there are challenges associated with liquid dosage, such as stability and palatability, parameters that need to be considered in the design.

Changing the lives of patients living with rare diseases requires collaboration, communication, and careful planning that incorporates regulatory, clinical, scientific, and commercial strategy. It also requires a commitment to advancing science to speed solutions.

Successful tech transfer is how long-term strategic CDMO relationships begin. A product’s continued success may hinge on this critical exchange of product data and required regulatory filings.

A comprehensive gap analysis examines documented procedures, SOPs, and QMS processes, but also includes discussions with key personnel and scrutinizes outputs derived from those SOPs and processes. Learn about the “report card” — an independent key deliverable that helps the organization identify, prioritize, and remediate potentially problematic areas.

Explore the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.

When moving from vial systems to prefilled syringes and autoinjector systems, factors to consider include patient and caregiver needs, drug product requirements, system components, and performance.

Oral solid dose experts Amy Trotch and Kieran Coffey offer insight into OSD coating techniques and technologies, and how to effectively scale and transfer them for commercial manufacturing. 

Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for use in clinical research. How does it work and how is it different from commercial manufacturing?

A clear path for establishing equivalency is needed to facilitate more rapid advances in the gene therapy field and ultimately to enable lower-cost gene therapies that reach patients faster than ever.

There is increased demand for lyophilization services in the manufacturing of new biologic drugs and injectable formulations as well as in change of formulation presentation.

Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future filled with uncertainty and disruption.

Understanding the significant competitive advantages of FDC products and the difficulties and potential pitfalls associated with their development and manufacturing in oral solid dosage forms is critical.

Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations through a crisis situation.

Four experts in post-discovery strategy share insights into methodologies, robust platform process design, high-throughput automation technologies, optimized workflows, and life cycle approaches.

Review key considerations for formulation screening of therapeutic proteins and how consistency, planning, and communication are essential for a successful biologic drug product tech transfer.