11.01.22 -- Jump-Start Your Next CDMO Outsourcing Project With This Checklist

In batch processing operations, numerous concurrent and independent steps can lead to bottlenecks, causing a process pause as downstream operations finish before preceding steps can move forward. 

The FDA believes a pre-submission meeting when a complex generic application has unusual elements will lead to more first-cycle approvals. Learn more communication enhancements in GDUFA III.

Using a case study, the author demonstrates how comparative statistical analysis enabled his team to improve the yield of a component used in API synthesis by more than 2.5 x 10⁸ U/batch.

Spray-dried dispersions, hot-melt extrusion, and solubilizing excipients are common solubility enhancement techniques, but new developments to maximize amorphous solid dispersion benefits are needed.

Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

We review a chemically defined Vero cell medium that provides the ultimate environment for improved Vero cell viability and yield, as well as high virus production, while maintaining a complete defined animal component-free manufacturing process.

Spray dryers today support the development of some of the most advanced drug formulations, meeting the most precise morphological requirements to ensure performance, stability, and manufacturability.

The increasing complexity of the drugs currently in clinical development has created mounting pressure for companies hoping to surmount the myriad of challenges that typify these therapeutic modalities.

Degradable polymers evolved from aliphatic polyesters to nitrogen-bearing biomaterials such as polyurethanes, polyester amides, and polyureas. Explore a brief history of the development of polyester amide (PEA) polymers.

We review a solution for the need for human models of GI risk assessment that can be utilized for drug optimization in early development.

A biopharmaceutical company known for its successful anti-infective products for adults sought to reformulate the product into an age-appropriate dosage form for young children and preteen patients.

Biotech investigators can’t possibly know everything required to move their drug candidate from the lab bench to the marketplace. Accepting that reality is the first step toward finding a strategic partner.

This article recounts a recent discussion with the general manager of Pfizer CentreOne, regarding what it’s like to lead an embedded CDMO within one of the largest pharmaceutical companies.

Kimberly Shepard, Ph.D., principal engineer in R&D, addresses the challenges associated with spray-drying late-stage lung cancer treatments, including proteins, peptides, and mAbs.

Three studies of a product that addresses unmet needs around the development of subcutaneous drug therapies for chronic disease treatment, including methods for sterilization and a human factors evaluation.

An ongoing strategic growth plan is expanding our manufacturing capacity and services across geographies so that we are better able to meet increased demand and have improved lead times for key products.

Hear from a global leader in contamination monitoring about how they are actively monitoring and reducing their environmental contamination on a path to NetZero.

In today’s global economy, your pharmaceutical materials and components may be sourced from all over the world. Learn about foreign trade zones and how they can improve your speed-to-market while saving thousands in duties.

This webinar will highlight recent advances in the development of a one-part chemically defined (CD) microbial medium to simplify workflows and achieve high-density cultures ideal for recombinant protein or plasmid production applications supporting therapeutics, gene therapy, and vaccine advancement.