Manufacturing, Continuous Biologics Processing

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

Flexibility and process intensification are advantages of continuous biopharmaceutical manufacturing, but some challenges remain.

Silicone is one of the polymeric materials that can be used for single-use components and assemblies in biopharmaceutical manufacturing.

WuXi Biologics will invest $60 Million to establish a biologics production facility in Massachusetts.

WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Early adopters are benefiting from lower costs and increased productivity.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

Single-use systems provide replaceable fluid paths.

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.

The agency is looking for industry input on best practices for continuous manufacturing.

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

The authors present a shift toward more integrated purification processes.

Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

Continuous downstream bioprocessing is proving its worth, but connecting different operations and integrating upstream remains a challenge.

Richard D. Braatz, PhD, will discuss using mathematical models to design a continuous drug manufacturing plant and the differences between batch and continuous operations for biologics.

A novel coiled flow inversion reactor (CFIR) improves process productivity and performance.

Biopharmaceutical manufacturers continue to put quality at the forefront of their relationships.

Advances in single-use systems, consumables, and continuous manufacturing show steady progress.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.

FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.

The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.

In semiconductor manufacturing, for example, a thorough understanding of process variation allows companies to manufacture circuits with billions of transistors at high yields. These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.

The “next-generation” design for the pods will build on Pfizer’s existing modular prototype for oral solid-dose manufacturing.

BioSC Lab biochromatography system performs protein purification in batch and continuous modes.