1,719 research outputs found
Point-of-Care Manufacture: Regulatory Opportunities and Challenges for Advanced Biotherapeutics
On 29 June 2021, UCL’s Future Targeted Healthcare
Manufacturing Hub (FTHMH) held an online workshop to discuss
the concepts and rationale of a new point-of-care (POC)
manufacturing regulatory framework in development by the UK’s
Medicines and Healthcare products Regulatory Agency (MHRA).
The proposal, which seeks to address the unique challenges of
manufacturing healthcare products at, (or close to), the POC, is
anticipated for publication and public consultation in summer
2021
The UK’s emerging regulatory framework for point-of-care manufacture: insights from a workshop on advanced therapies
Point-of-care (POC) manufacture can be defined as the production of therapies in clinical settings or units close to hospitals and patients. This approach is becoming increasingly via- ble due to the emergence of flexible manufacturing technologies. Expecting an increase in this kind of production, the UK’s regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) is proposing a regulatory framework specifically designed for POC manufacture. To discuss the challenges of POC manufacture and the MHRA’s pro- posal, the EPSRC Future Targeted Healthcare Manufacturing Hub (FTHMH) organized a workshop drawing insights from specialists in cell and gene therapy manufacture. Through presentations and discussion roundtables, the workshop highlighted the challenges for the UK and other countries implementing POC manufacture. The workshop attendees stressed four main issues: quality control; standardization and equipment use; availability of qualified personnel; and the challenges to be met by hospitals participating in POC manufacture systems. This commentary provides a summary of the points discussed in this workshop
A Bichromatic Incidence Bound and an Application
We prove a new, tight upper bound on the number of incidences between points
and hyperplanes in Euclidean d-space. Given n points, of which k are colored
red, there are O_d(m^{2/3}k^{2/3}n^{(d-2)/3} + kn^{d-2} + m) incidences between
the k red points and m hyperplanes spanned by all n points provided that m =
\Omega(n^{d-2}). For the monochromatic case k = n, this was proved by Agarwal
and Aronov.
We use this incidence bound to prove that a set of n points, no more than n-k
of which lie on any plane or two lines, spans \Omega(nk^2) planes. We also
provide an infinite family of counterexamples to a conjecture of Purdy's on the
number of hyperplanes spanned by a set of points in dimensions higher than 3,
and present new conjectures not subject to the counterexample.Comment: 12 page
Translation rates of isolated liver mitochondria under conditions of hepatic mitochondrial proliferation
Simultaneous Embeddings with Few Bends and Crossings
A simultaneous embedding with fixed edges (SEFE) of two planar graphs and
is a pair of plane drawings of and that coincide when restricted to
the common vertices and edges of and . We show that whenever and
admit a SEFE, they also admit a SEFE in which every edge is a polygonal curve
with few bends and every pair of edges has few crossings. Specifically: (1) if
and are trees then one bend per edge and four crossings per edge pair
suffice (and one bend per edge is sometimes necessary), (2) if is a planar
graph and is a tree then six bends per edge and eight crossings per edge
pair suffice, and (3) if and are planar graphs then six bends per edge
and sixteen crossings per edge pair suffice. Our results improve on a paper by
Grilli et al. (GD'14), which proves that nine bends per edge suffice, and on a
paper by Chan et al. (GD'14), which proves that twenty-four crossings per edge
pair suffice.Comment: Full version of the paper "Simultaneous Embeddings with Few Bends and
Crossings" accepted at GD '1
On the Number of Facets of Three-Dimensional Dirichlet Stereohedra III: Full Cubic Groups
We are interested in the maximum possible number of facets that Dirichlet
stereohedra for three-dimensional crystallographic groups can have. The problem
for non-cubic groups was studied in previous papers by D. Bochis and the second
author (Discrete Comput. Geom. 25:3 (2001), 419-444, and Beitr. Algebra Geom.,
47:1 (2006), 89-120). This paper deals with ''full'' cubic groups, while
''quarter'' cubic groups are left for a subsequent paper. Here, ''full'' and
''quarter'' refers to the recent classification of three-dimensional
crystallographic groups by Conway, Delgado-Friedrichs, Huson and Thurston
(math.MG/9911185, Beitr. Algebra Geom. 42.2 (2001), 475-507).
Our main result in this paper is that Dirichlet stereohedra for any of the 27
full groups cannot have more than 25 facets. We also find stereohedra with 17
facets for one of these groups.Comment: 28 pages, 12 figures. Changes from v1: apart of some editing (mostly
at the end of the introduction) and addition of references, an appendix has
been added, which analyzes the case where the base point does not have
trivial stabilize
Mortality Measurement Matters: Improving Data Collection and Estimation Methods for Child and Adult Mortality
Colin Mathers and Ties Boerma discuss three research articles in PLoS Medicine that address the measurement and analysis of child and adult mortality data collected through death registration, censuses, and household surveys
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