Scale Up

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

Eli Lilly was awarded the 2017 FOYA Overall Winner for its continuous direct compression manufacturing installation projects.

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

Continuous twin-screw granulation offers several options for increasing production scale. Thermo Fisher Scientific explains factors to consider in scale-up projects for manufacturing oral solid-dosage drugs.

Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

PharmTech sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.

Transferring the manufacturing of a drug from one scale to another or between manufacturing sites presents both technical and business challenges.

Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.

Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with Pharmaceutical Technology about collaborative success strategies for biopharm companies.

Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.

Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.

This article focuses on the growing need for effective data management in the life sciences industry-especially among smaller pharmaceutical manufacturers.

Ties between the biotechnology industry and university research are crucial.

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

An understanding of the pan-coating process based on first principles can support successful scale up.

There are various theories about how to scale up a solid dosage coating operation in a pan coater. This article provides a basic process understanding and scale-up theory based on first principles.

Critical issues that should be considered when scaling up a hot-melt extrusion process.

With the increasing use of hot-melt extrusion, extruder manufacturers have developed mid-size twin-screw extruders that facilitate process development and scale-up to commercial processes.