Formulation and Device Lifecycle Management of Biotherapeutics
A Guidance for Researchers and Drug Developers

Explores various aspects of Formulation Device Lifecycle Management for biotherapeutics, including how and when to conduct related development activities

Beate Bittner (Author), Johannes Schmidt (Author)

9780128237410

Paperback, published 20 January 2022

228 pages, 35 illustrations (10 in full color)
22.9 x 15.2 x 1.6 cm, 0.45 kg

Approx.214 pages

1. Enabling customer-centric and sustainable drug delivery—formulation and device lifecycle management of biotherapeutics
2. Clinical development of subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies—pharmacokinetic-based bridging approach
3. Clinical development of automated subcutaneous injection devices—established pathways and novel concepts
4. Enabling a flexible care setting in oncology—how to realize home- and self-administration of biotherapeutics in cancer care
5. Formulation and device lifecycle management of biotherapeutics—leveraging synergies across therapeutic areas
6. Formulation and device lifecycle management of biotherapeutics—decision architecture
7. Summary and outlook

Subject Areas: Materials science [TGM], Biotechnology [TCB], Pharmacology [MMG], Pharmaceutical industries [KNDP]