PMID- 32105759
OWN - NLM
STAT- MEDLINE
DCOM- 20210617
LR  - 20210617
IS  - 1873-4995 (Electronic)
IS  - 0168-3659 (Linking)
VI  - 321
DP  - 2020 May 10
TI  - Accelerating the development of novel technologies and tools for the subcutaneous 
      delivery of biotherapeutics.
PG  - 475-482
LID - S0168-3659(20)30126-7 [pii]
LID - 10.1016/j.jconrel.2020.02.036 [doi]
AB  - Subcutaneous (SC) delivery of biotherapeutics is well established as a route of 
      administration across many therapeutic areas and has been shown to be effective 
      and well-tolerated. It can offer several advantages over intravenous 
      administration. This notwithstanding, there remain critical development issues 
      and knowledge gaps in SC drug delivery. To articulate and address these issues, 
      the SC Drug Delivery and Development Consortium was convened in 2018 as a 
      pre-competitive collaboration of industry experts in drug delivery, device 
      development, and commercialization. In this review, we outline the Consortium's 
      vision and mission in advancing the development of patient-centered 
      biotherapeutics and establishing a collaborative organization that facilitates 
      open sharing of information and gives voice to diverse viewpoints from SC experts 
      across industries and disciplines. Additionally, we describe the current 
      landscape and challenges associated with SC administration of therapeutic 
      proteins (specifically monoclonal antibodies) and offer insights into potential 
      solutions to these challenges within the context of 8 problem statements 
      developed by the Consortium to highlight key gaps, unmet needs, and actionable 
      issues. Current and future opportunities to accelerate progress in the field 
      through technological advances and the development of drug delivery tools are 
      also discussed.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Collins, David S
AU  - Collins DS
AD  - Eli Lilly Innovation Center, 450 Kendall Street, Cambridge, MA 02142, USA. 
      Electronic address: collins_david_s@lilly.com.
FAU - Sanchez-Felix, Manuel
AU  - Sanchez-Felix M
AD  - Novartis Institutes for BioMedical Research, 700 Main Street, Cambridge, MA 
      02139, USA.
FAU - Badkar, Advait V
AU  - Badkar AV
AD  - Pharmaceutical R&D, Biotherapeutics Pharm Sci, Pfizer Inc, 1 Burtt Road, Andover, 
      MA 01810, USA.
FAU - Mrsny, Randall
AU  - Mrsny R
AD  - Department of Pharmacy and Pharmacology, University of Bath, Bath BA2 7AY, UK.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20200224
PL  - Netherlands
TA  - J Control Release
JT  - Journal of controlled release : official journal of the Controlled Release 
      Society
JID - 8607908
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - Administration, Intravenous
MH  - Antibodies, Monoclonal
MH  - *Drug Delivery Systems
MH  - Humans
MH  - Injections, Subcutaneous
MH  - *Subcutaneous Tissue
OTO - NOTNLM
OT  - Bioavailability
OT  - Biotherapeutics
OT  - High dose/volume
OT  - Patient-centered drug development
OT  - Preclinical modeling
OT  - Subcutaneous drug delivery
EDAT- 2020/02/28 06:00
MHDA- 2021/06/22 06:00
CRDT- 2020/02/28 06:00
PHST- 2020/01/28 00:00 [received]
PHST- 2020/02/21 00:00 [revised]
PHST- 2020/02/23 00:00 [accepted]
PHST- 2020/02/28 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/02/28 06:00 [entrez]
AID - S0168-3659(20)30126-7 [pii]
AID - 10.1016/j.jconrel.2020.02.036 [doi]
PST - ppublish
SO  - J Control Release. 2020 May 10;321:475-482. doi: 10.1016/j.jconrel.2020.02.036. 
      Epub 2020 Feb 24.