Articles
-
6 capabilities to look for in a CDMO
Before making a commitment, do a deep dive into whether a prospect is right for your emerging biotech company.
-
Basics of process development for biotherapeutics
Definitions, activities by stage of drug development, and things to consider when developing an upstream or downstream bioprocess.
-
Cell line development for viral vector production
Lentiviral vector production represents a large portion of the costs for CAR T cell therapies. Here we discuss ways to reduce LV costs and describe a case study.
-
Cell therapy development and validation
Options to minimize risks and prepare for successful commercial production.
-
China’s pharmaceutical market surging
Driven by market gaps and R and D investments three times the global average
-
Flexible single-use biomanufacturing design
Thomas Page and Parrish Galliher reflect on lessons learned from implementing the modified ballroom concept for biomanufacturing. They also share some points to consider and discuss future moves.
-
Funding considerations for early-stage biopharma
Deliver groundbreaking treatments to patients in need quickly by pursuing the right funds at the right time.
-
GMP in house or outsource
Considerations to help you determine which strategy best suits your process, product, and team.
-
Improving lentiviral vector downstream processing workflows
Industry experts address industry pain points during a cell and gene therapy event for emerging biotech companies.
-
Platform cell and gene therapy media development
A rigorous approach uses design of experiments and high-throughput screening to identify a robust serum-free formulation.
-
Pluripotent stem cell expansion and scale-up
Best practices for development and scale-up of an upstream stem cell therapy process.
-
Regulatory review of new drugs
Navigate regulatory policies effectively and achieve regulatory compliance efficiently with discerning strategies for drug study, review, and approval.
-
Robust process design for cell therapies
Set yourself up for success in cGMP manufacturing by understanding, measuring, and controlling variability.
-
Staying flexible in biomanufacturing
Buy vs build decision in biomanufacturing: financial analysis should include intangibles such as loss of market share and tying up Capex early in drug development.
-
The role of CDMOs in cell and gene therapy process development
Scale-up, tech transfer, and other areas where they can help.
Webinars
-
Automation solutions
Automation in process development and biomanufacturing
-
Risk management
Sustainable supply and risk management programs: challenges and considerations
-
Single-use – impact on operations
Shire and Cytiva discuss impacts and propose solutions for successful MES implementation
-
Build or buy
The decision to outsource manufacturing or produce a therapeutic product in house
Tools
-
Online tools and calculators
Check out our range of calculators, converters and selection guides will help save you time in the lab
-
Life science online courses
Browse our free eLearning courses and grow your skills
-
Glossary of regulatory terms
Navigating the regulatory landscape can be challenging if you’re not familiar with all the terms. Familiarize yourself with key regulatory processes, terms, and acronyms.
Videos
-
Chronicle™ Software: Scaling for needs in cell therapy
-
Chronicle™ Software: Automating batch records
-
Chronicle™ Software: Mitigating risks in production
-
KUBio: The proven response for rapid biomanufacturing
-
Preclinical and clinical biologics CDMO services up to phase II
-
Convert processes to single-use technologies
-
Visit Cytiva YouTube Library