Newsletter | November 21, 2022

11.21.22 -- The "Outsourcing Master Class": 10 Modules For Success

From The Editor
Featured Editorial
Industry Insights
Establishing A Remote Audit Process As A CDMO

Compliance audits are not immune to the effects of the pandemic. We have been required to adapt quickly to the changing environment to maintain high service levels while protecting employee and client safety.

A Molecule’s Journey: Break Down Roadblocks To Commercial Manufacturing Success

Our experts share key considerations for biopharmaceutical companies as they advance to commercial manufacturing and navigate complexities associated with business planning, process scale-up, optimization and validation, technology considerations, and regulatory compliance.

Spray-Dried Dispersions Enable Local Delivery For Lung Cancer

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

Development And Manufacturing: Success With HPAPI

Dr. Michiya Hayakawa shares strategies for manufacturing HPAPI (highly potent active pharmaceutical ingredient) drugs and key points for promoting projects that utilize special formulation technologies.

Insights On Cell And Gene Therapy Manufacturing

Since the early 1990s, gene therapy has revolutionized medicine. In the coming years, it will continue to become more relevant in the treatment and cure of some of the most severe diseases and disorders.

Three Reasons Integrated CDMO Models Are Best

Some of pharma’s top brands developed their own responses to the demand for strategic outsourcing, creating a distinct class of contract development and manufacturing services suppliers.

Biopharmaceutical Manufacturing: Why Australia?

World-class researchers, state-of-the-art facilities, a streamlined regulatory framework, and generous tax incentives have made Australia a prime location for the biotech industry.

It Hasn’t Been Easy For Pharma To Be Green

Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic wastes that pose safety concerns or require costly remediation.

Tuning Intermediate Volumes On Sepax C-Pro Cell Processing System

Discover how we automate the optimizing cell harvesting process and further minimize the potential for cell loss during wash steps.

Investing In Capacity: API Commercial Manufacturing

A pharmaceutical company sought a CMO partner with commercial manufacturing capabilities and expertise and exemplary quality systems to find a cost-effective process to produce the API for a new drug.

Risky Assumptions For Addressing Limited Bioavailability

Bioavailability challenges are an inherent part of the drug development process. Review some risky assumptions surrounding bioavailability issues during development and key considerations for addressing them.

Spotlight On Clinical Operations

The role of clinical operations plays an important part in the overall drug development process. Ian Nisbet, global vice president of clinical operations at Quotient Sciences, shares more about clinical operations.

Coating: Curing Your Complex Oral Solid Dose Challenges

Pfizer CentreOne’s oral solid dose experts discuss how advances in the mathematics and engineering involved in understanding the process can tackle challenges and ensure functional coating and drug layering continue to be a viable solution for the next generation of OSD drug products. Discover how coatings expertise could transform your OSD drug.

Reduce Inhalation Burden With High-Dose, Carrier-Free Spray-Dry Powders

Explore how spray-dried particles provide an attractive, carrier-free option for highly dispersed delivery of API to deep lung regions, utilizing an alternative approach to large, porous particles.

Outsourced Pharma Live

Available On Demand! Throughout the year, chief editor Louis Garguilo brings together industry experts to discuss some of the biggest challenges being faced by both sponsors and CDMOs. Our archived videos can be accessed at any time by registered site users.