Manufacturing

Adding to an existing $115-million investment, the 700,000-ft2 site in Longmont, CO will expand AveXis’ gene-therapy manufacturing capacity.

In OSD continuous manufacturing, flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.

FDA is moving to shift industry away from step-wise batch production.

Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.

Pharmaceutical Technology Europe spoke with Manuel Leal, business development director for Idifarma to learn more about spray drying and how it can support patient-centric drug development.

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Pharmaceutical Technology spoke with Roger Croucher, senior manager, R&D projects, at Catalent Pharma Solutions; Daniel M. Bowles, senior director, chemical development, at Cambrex; and Kurt J Kiewel, director, new product development and analytical services, also at Cambrex about best practices for a successful technology transfer.

Successful technology transfer depends on the ability to anticipate risks and plan ahead.

Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.

The Ross PowerMix is a hybrid planetary mixer suited to address the need for high shear in formulations too viscous for conventional dual-shaft mixers.

When specifying an automated powder transfer system for vacuum conveying of pharmaceutical powders, consider material properties, facility constraints, and designs to mitigate explosion.

The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.

Sticking and picking are common problems in tablet manufacturing. Considering tablet compression issues before tablet designs are finalized can prevent unanticipated problems during scale-up and full-scale production.

Flexibility and well considered manufacturing approaches could help tablet manufacturers face the increasing pressure resulting from the shifting bio/pharma development landscape.

Market demand and regulatory guidance continues to promote improved medication design.

The GE Healthcare and Rockwell Automation collaboration will help meet the needs of the biopharma 4.0 era.

NJII and Pall collaborate to address biomanufacturing technology and workforce development challenges.

The company has launched a comprehensive portfolio of custom cell biology solutions and a new cell-line engineering technology.

Valitacell, Solentim, and Microcoat were awarded EUR 3.5 million (US$4 million) to produce an integrated platform to deposit, culture, profile, and select optimal cells for biologic drug manufacturing.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

Distek, a provider of laboratory testing instruments, added a dual impeller single-use bioreactor (SUB) system to its BIOne portfolio.

A continuous peptide manufacturing process invented by Swedish Biomimetics 3000 Ltd is a platform technology also applicable to other solid-phase chemical processes, such as chromatography.

Belgium-based CDMO MaSTherCell will expand its European manufacturing capacity for cell and gene therapy products by setting up a new facility in Belgium.

Serialization-ready packing equipment and services to manage data assist companies with DSCSA compliance.

The Dual Cell-E Robotic Palletizer from ESS Technologies integrates a FANUC robot with custom-designed end-of-arm tooling for palletizing in a small footprint.

At INTERPHEX 2019, MG2/MG America stages a packaging/processing summit; exhibitors offer packaging equipment innovations for parenteral products.

Think ahead to production requirements when planning strategies in early development of gene and cell therapies.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

The Pharma Services business of Thermo Fisher Scientific will invest $150 Million at three facilities.