Page 166 - CW E-Magazine (19-3-2024)

News from Abroad

SUSTAINABLE ALTERNATIVE
Hovione partners Dragonfly Technologies to advance

micellar chemistry tech

Hovione, the Portugal-based inte- product manufacturing. Gaining access
grated CDMO and leader in spray drying to Dragonfly’s groundbreaking micellar
and particle engineering, has signed an technology is a key step in our journey
agreement with Dragonfly Technologies to introduce more sustainable manu-
to gain access to its micellar technology facturing options at an industrial scale.
for chemistry-in-water processes, deve- This proprietary process technology
loped by Prof. Bruce Lipshutz of the enables the use of less energy-intensive
University of California, Santa Barbara avoidance of rare and expensive metal conditions, lower levels of precious
(UCSB). Hovione will further progress catalysts. At the same time, by minimis- metal-containing catalysts, and lesser
the technology to make it an integral ing the use of organic solvents, it can use of organic solvents.”
part of its API manufacturing techno- also reduce the carbon footprint of the
logy offering. Micellar chemistry enables desired chemical reactions. Prof. Bruce Lipshutz said, “This
multiple chemical transformations to agreement will help ensure that aque-
take place in nanomicelles dispersed Dr. Jean-Luc Herbeaux, Hovione’s ous micellar technologies will have
in water, mimicking natural chemical CEO commented, “Manufacturing of wider and faster market adoption, bene-
transformations. The technology allows APIs and their intermediates make up fiting the industry as a whole, by ena-
reactions to occur at lower temperatures a significant proportion of the overall bling the development of nature-based
and enables the reduction or even the carbon footprint of pharmaceutical sustainable processes in water.”
EXPANDED CAPABILITIES
CordenPharma expands early clinical phase peptide

APIs capacity in Germany

German full-service pharma Con-
tract Development & Manufacturing
(CDMO), CordenPharma, has commis-
sioned its new GMP capacities at Frank-
furt to manufacture early clinical phase
peptide APIs for pharma and biotech
customers. The investment, which is still
being finalised, will be fully operational
in Q2 2024 and authorised by German
authorities in H2 2024. This follows an starting material batch release, and of an integrated service offering bet-
expansion of the Frankfurt site in 2020 GMP stabilities. The GMP manufactur- ween the Frankfurt site (for peptide drug
for non-GMP manufacturing. ing area is designed to produce peptide substance) and Caponago, Italy site (for
APIs from gram to kilogram range for injectable drug products) to deliver fully
The Frankfurt site will add 1,000-m clinical phase 1 and 2 requirements. As customisable technical, manufacturing,
2
of manufacturing space, including two the project progresses along the custo- and regulatory support that is specifi-
fully equipped lines comprised of a mer lifecycle, the new state-of-the-art cally targeted to enable efficient IND
Solid Phase Peptide Synthesiser (SPPS), technologies will enable a smooth and (Investigational New Drug)/Investiga-
High Pressure Liquid Chromatography seamless transfer to the late phase and tional Medicinal Product Dossier (IMPD)
(HPLC), Liquid Phase (LP), isolation commercial manufacturing site of the filings, with all the necessary materials
equipment and quality control laborato- company in Colorado (Boulder, US). needed to initiate customers’ First In-
ries including In Process Control (IPC), The GMP expansion supports the launch Human (FIH) clinical trials.

166 Chemical Weekly March 19, 2024

Contents Index to Advertisers Index to Products Advertised