Search results for " interchangeability"
Article
Managing Biomanufacturing Capacity Expectations
…ore clear—but in the United States, physician acceptance and prescribing practices (as well as the interchangeability status of a biosimilar) may make launch and capacity predictions increasingly cha…
Article
Best Practices in Qualification of Single-Use Systems
When developing specifications, functional specifications should be taken into account to allow SUS or component interchangeability wherever feasible.
The next step is to perform a gap analysis in…
Article
What’s In a Name? For Biosimilars, A Lot
…shared compendial identity does not necessarily imply or mandate an FDA determination of sameness or interchangeability” (1). BioPharm International spoke to USP to find out a bit more about how the …
Article
Securing the Single-Use Supply Chain
One alternative to dual sourcing is, according to Philips, to limit the number of contact materials in single-use systems and aim to create interchangeability for any layer (e.g., films, filters, valv…
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
Article
Continuous Chromatography: Trends, Definitions and Approaches
Process Development Forum speaks with Karol Lacki, Customer Collaborations Leader at Cytiva, about continuous chromatography.
There is a lot of attention being paid to continuous chromat…
Article
New Era for Generic Drugs
…d over product “naming” to distinguish innovators from biosimilars, as brands look to discourage interchangeability and substitution of future biosimilars.
Successful biosimilar development must c…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
Article
Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…