Process Development

As the AI-first era matures, life sciences leaders must pivot from narrow, task-specific models toward integrated, interpretable frameworks that transform biological complexity into a sustainable competitive advantage.

Green chemistry is emerging as a strategic lever for biopharma manufacturing, enabling safer processes, efficiency gains, and long-term competitiveness.

As adenovirus vectors continue to evolve into versatile platforms for vaccines and complex therapeutics, advances in vector design and formulation are proving critical to ensuring manufacturing consistency, therapeutic potency, and patient-ready delivery at scale.

Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.

Incorporating sustainable practices into process designs as early as possible ensures optimal performance.

Hurdles exist across all aspects and phases of drug development and manufacturing.

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

The optimization of processes for the development and manufacture of biopharmaceuticals is pivotal for producing quality products.

Cambrex will provide Lilly’s biotech collaborators with accelerated access to clinical development capabilities.

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.