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BioPharm International, June 2022 Issue
Early Strategizing Tightens Development Timelines
June 02, 2022
Cover Story
35
6
Having a clear clinical strategy early on can shave time off overall development projects.
Employing Genomics Tools to Accelerate Drug Development
June 02, 2022
Cover Story
35
6
Advances in genomics tools can lead to quicker biotherapeutic development.
Bispecific Antibodies are Moving from Research to Clinical Development
June 02, 2022
Development
35
6
With recent approvals of bispecific antibodies, these complex molecules are fast moving out of the research box and into clinical pipelines.
Considerations for US Fetal Bovine Serum Sourcing
June 02, 2022
Upstream Processing
35
6
Extensive work has greatly expanded the possibilities for fetal bovine serum sourcing.
Advancing Process Chromatography in DSP
June 01, 2022
Downstream Processing
35
6
Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.
Pre-filled Syringes Show Strong Growth
June 01, 2022
Manufacturing
35
6
Demand spurs innovations in syringes and syringe fill/finish operations.
GMPs for Sterile Manufacturing of Biologics
June 01, 2022
35
6
The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.
Method Development for Biosimilar Analysis
June 01, 2022
Analytics
35
6
Linking structure with function is paramount.
When Is It Appropriate to Outsource Bioanalysis Work to a CRO?
June 01, 2022
Outsourcing
35
6
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 to Continue Inspection Efficiencies After Pandemic
June 01, 2022
Regulatory Beat
35
6
FDA will use virtual site visits even after resuming active inspections.
Coming Together to Enable Cell and Gene Therapy Manufacturing
June 01, 2022
BioBusiness
35
6
Precompetitive consortiums seek solutions to industry-wide challenges.
Productive Client-CDMO Relationships
June 01, 2022
35
6
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.
Pharmaceutical Transport Container
June 01, 2022
Product Spotlight
35
6
The KTEvolution from Tower Cold Chain is a lightweight, reusable container designed for the transport of pharmaceutical products.
Next-Generation Cas9 Proteins
June 01, 2022
Product Spotlight
35
6
Thermo Fisher's Invitrogen TrueCut HiFi Cas9 Protein significantly reduces off-target events while retaining maximum on-target editing efficiency.
Is AI a Panacea for Pharma’s Productivity Gap?
June 01, 2022
From the CEO
35
6
AI could provide solutions to critical manufacturing inefficiencies.