BioPharm International, June 2022 Issue

Having a clear clinical strategy early on can shave time off overall development projects.

Advances in genomics tools can lead to quicker biotherapeutic development.

With recent approvals of bispecific antibodies, these complex molecules are fast moving out of the research box and into clinical pipelines.

Extensive work has greatly expanded the possibilities for fetal bovine serum sourcing.

Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.

Demand spurs innovations in syringes and syringe fill/finish operations.

The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.

Linking structure with function is paramount.

When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

FDA will use virtual site visits even after resuming active inspections.

Lions and tigers and monkeypox, oh my!

Precompetitive consortiums seek solutions to industry-wide challenges.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

The KTEvolution from Tower Cold Chain is a lightweight, reusable container designed for the transport of pharmaceutical products.

Thermo Fisher's Invitrogen TrueCut HiFi Cas9 Protein significantly reduces off-target events while retaining maximum on-target editing efficiency.

AI could provide solutions to critical manufacturing inefficiencies.