Upstream Processing

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

Improving the flexibility of cell line development through utilization of platform approaches and suitable partnerships can reduce potential bottlenecks in the development pathway of novel biologics.

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

Using a multi-pronged strategy to find optimum, tailored formulations is best.

This commentary summarizes the derivation of clonal HEK293 suspension cell lines, selection of clones for rAAV production, and design of experiments-based optimization strategies for characterization of one clonal isolate for high yield rAAV manufacture. Data shown provides proof of concept for the success of this strategy, its applicability for manufacturing different rAAV serotypes and lays the foundation of further clonal cell line characterization for scale up of production.

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.

This investment will bolster the company’s large-scale cell culture CDMO business at its planned Fujifilm Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina.

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

A tidal wave of questions floats the need for more upstream automation.

Challenges in fermentation can be addressed through equipment changes, facility design, and process development.

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.

Tome Bioscience is facilitating the transition in biology from the editing phase to the cut-and-paste phase.

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

The construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

Using a systematic approach and achieving run-to-run consistency are essential.

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.

Media developers and vector manufacturers face a combination of challenges and opportunities.