Biologics have revolutionized cancer treatment, reversed the course of immune-related conditions, and offered new hope for patients with compromised health conditions. Northway Biotech, an end-to-end biologics CDMO, supports its biopharmaceutical clients with a new, state-of-the-art, process development and cGMP manufacturing facility. Having scientific expertise that accelerates time-to-market and that is invested in technology supporting gene to drug product, Northway Biotech presents a virtual, grand opening experience. Click here to register.
In its quest to produce affordable, scalable lentiviral-based gene therapies, AVROBIO is applying concepts from small molecule, biologics, and transplant technologies to pioneer automated gene therapy manufacturing systems.
When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP.
By Michael Sibley, Angus Woodhams, et al.,Sartorius Stedim Biotech
This poster describes the rapid transfer of Raman spectroscopy models from process development (PD) to commercial manufacturing scale, including results of process scalability tests and successful model transfer.
Adding biologics to your pipeline requires innovative approaches to drug development and cost mitigation. Simplifying the recombinant protein production and purification processes is a good place to start.
Centrifugation and filtration have been widely accepted as techniques required for clarifying complex cell cultures to recover extracellular proteins such as monoclonal antibodies (mAbs). This scientific brief offers an alternative.
This webinar covers the key considerations for formulation screening of therapeutic proteins with a focus on maintaining protein stability and avoiding aggregation.
Join us on January 26, 2021, at 10:00 a.m. EST when Cell & Gene’s chief editor, Erin Harris, talks to Acepodia’s Mark Gilbert, M.D., Celyad Oncology’s Thomas Lequertier, and SOTIO’s Luděk Sojka, Ph.D., about the innovations in manufacturing that can reduce both costs and risks in producing new cell and gene therapies.