Manufacturing Equipment, Upstream Processing

Optimizing the harvest of viral particles is important for the yield and purity of the final product.

Under a £15.7 million (US$20.7 million) investment, SEKISUI has expanded its UK site for clinical-grade drug substance manufacturing.

With financing led by OrbiMed, Novo Holdings, and Jeito Capital, Alentis Therapeutics will develop a pipeline of Claudin-1-targeted ADCs to treat solid tumors.

Stable cell line development can benefit from applying integrated analytical technologies.

Optimizing AAV vector manufacturing will be necessary to meet anticipated future market demand.

Freudenberg Medical now offers custom single-use assemblies to expand its offerings in silicone extrusion and molding for biopharma applications.

Under the expanded agreement, Univercells and University of Pennsylvania will evaluate certain bioreactors for scalable gene therapy production.

AGC Biologics has completed an expansion at its Copenhagen, Denmark, site, which doubles its bioreactor capacity for mammalian-based cell culture.

Global product manager at Cytiva, Eric Corti, discusses the challenges with designing a new single-use mixing system that ensures leak-free fluid handling operations at INTERPHEX 2024.

Despite a growing trend toward single-use bioreactors, stainless-steel retains its relevance for certain products.

The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.

Abzena has launched its AbZelect platforms, designed for improving cell line development.

The authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.

Both adherent and suspension cell culture approaches have their pros and cons, which must be considered for process development.

Pharmaceutical Technology Europe® spoke with Fiona Bellot, sales director, Cellexus BioreactorSystems, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Re-evaluating the basics of mAb production may be beneficial for the biopharma industry as a whole.

Process and bioreactor performance are directly impacted by real-time monitoring capabilities.

Sartorius’ Biostat STR now incorporates Repligen’s XCell ATF hardware.

Scale-up strategies for cell culture will require a deep understanding of overall bioprocess workflows.

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.

The choice of expression system requires wise consideration of product complexities.

The bioreactor scaler tool helps scaling between development and manufacturing and to de-risk scaling activities and ensure product quality.

The innovation of going from stainless-steel bioreactors to fixed-bed bioreactors shows an evolution in upstream optimization.

Using a predictive modeling approach can help tighten up operator control over bioprocessing, which in turn can increase bioreactor output.

Cytiva’s acquisition of CEVEC Pharmaceuticals strengthens the company’s cell line development and biomanufacturing capabilities.

The industry revisits the pros and cons of microbial fermentation at scale for biotherapeutics.

Successful scale-up and BLA filings for products manufactured by microbial biomanufacturing require strategic planning.

Industry adoption of plant-made biologics remains slow, but plant-based technology gains an advantage by mainstream exposure.

MilliporeSigma’s new BioContinuum Seed Train Platform offering enables a fully closed bioprocessing environment for both fed-batch and perfusion N-production.

The expansion at Seqirus’ Holly Springs, N.C., manufacturing facility will support the formulation and fill/finish of influenza vaccines.