Process Development

Space-time yield is a critical metric for comparison of upstream biomanufacturing processes and can be useful in reducing commercial production costs.

Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.

Lives are saved when time from vein to vein decreases.

Decreasing vein to vein time saves lives.

There is growing pressure for robust and economically scalable viral-vector manufacturing technologies.

A novel mathematical approach for fitting concentration-response curves is proposed that offers a more accurate estimation of potency data.

Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.

A simplified downstream process can save time and costs but requires enabling technologies.

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

As we reach further afield in the molecular universe, we encounter new types of problems to resolve.

Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.

An increasingly complex development pipeline and industry considerations, such as sustainability, are leading to a greater need for more efficient separation and purification in downstream processing.

Some progress has been made, but improvements are needed when harvesting cells for cell therapies.

This article summarizes industry views on PAT in bioprocess-related applications and presents a vision for the biopharmaceutical industry to achieve Industry 4.0.

New technologies are treatments are emerging to tackle COVID-19 and its assortment of new variants.

Flexible and efficient methods are needed for biopharmaceutical manufacturing.

Experience is an invaluable asset for outsourcing partners, particularly as more challenging method development services are in demand.

Shifting demands from industry innovators is leading to an increased need for flexible and agile outsourcing partners offering broad and integrated models.

Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.

Modeling techniques can improve process control and monitoring in biopharmaceutical production.

Qualified algorithms enable validation of machine learning models that can be used for process optimization.

Genezen has opened its new process development and analytical lab for viral vector production.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Ajinomoto and its subsidiary company, Ajinomoto Genexine, have partnered with Insilico Biotechnology to accelerate and improve process development and production of biologics using digital twin technology.

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

According to Charles River Laboratories, when asked how long it takes for a drug to be developed and approved for market in the United States, only 10% of 1,500 Americans polled correctly estimated that it takes between 10 and 15 years.

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.