Pharmaceutical Outsourcing Q2 2024 - 39

INDUSTRY NEWS
SECTION TITLE
* ChargeBag® QF (Quick-Fill): The ChargeBag QF (QuickFill) bag
is designed to speed up the dispensing and transfer of biopharmaceutical
and chemical powders in high throughput
production environments such as buffer and cell culture media
preparation. To reduce the risk of spillage and waste it features
a large 'full diameter' top-opening for fast filling and easy fine
tuning of target weight and a separate process connection port
meaning the bag does not need to be rotated. In addition, its
top-opening features and flexible skirt to protect the main bag
chamber and filling stand from external contamination during
this process to reduce clean up time. ChargeBag QF is available
in both 2D and 3D format at volumes from 10 to 150L and is
easy to implement into new or existing facilities.
* ChargePoint SUP: The larger sized DN150 (6 " ) Single Use
Passive adds to the existing DN100 offering and connects
to ChargePoint(R) Split Butterfly Valve (SBVs) with a 150mm
aperture and supports the transfer of powders up to and
beyond 150L in volume. The system can help contain a
broad spectrum of products such as HPAPI's (Highly Potent
Active Pharmaceutical Ingredients) and those with aseptic
processing as part of a hybrid single-use / multi-use system
ensuring manufacturers get both cost efficiency, flexibility
and also performance. The SUP works in perfect harmony
with the ChargeBag, in particular, welded directly to the new
3D ChargeBag XL for a complete single use container/closure
combination. The SUP can also be supplied with a Tri-Clamp
ferrule for connection to containers or other bag technology.
Chris Eccles, CEO of ChargePoint Technology, commented on the news:
" The new facility will become a center of excellence at ChargePoint
HQ as we introduce a dedicated product development and test cell.
Alongside the opening, we're about to launch three new products that
mark a significant milestone in ChargePoint's growth strategy as we
look to expand our operations and evolve our solutions to meet our
customers' ever-changing needs.
This is just the beginning of a busy year for ChargePoint and we
look forward to sharing further developments with our customers
very soon! "
Clinical Microbiomics Launches Advanced
Long-Read 16S, ITS, 18S, Isolate, and
Metagenomics Sequencing Services
Clinical Microbiomics, a leader in microbiome analysis, announces
the launch of its advanced long-read sequencing services. Tailored to
meet the stringent requirements of academic, clinical, and industrial
researchers, the expanded offerings deliver unmatched insights into
microbial communities, featuring the industry's highest quality scores
and read lengths.
Anders Grøn, CEO, states, " Our enhanced long-read sequencing
capabilities are redefining the standards in microbial analysis and
microbiome research. By broadening our range to include 16S, ITS, 18S
rRNA, custom gene sequencing, and comprehensive genomics and
metagenomics, we offer a more extensive and innovative perspective
on microbial ecosystems. This advancement marks a revolutionary
step in our ability to understand and leverage microbial interactions
within the realms of health, disease, and environmental studies. "
Manoj Dadlani, CCO and Chairman, adds, " The acquisition of
DNASense, co-founded by Profs. Mads Albertsen and Per Halkjær
Nielsen, esteemed members of the Oxford Nanopore Technologies
(ONT) developer community, has been crucial in boosting our
sequencing and analytical capabilities. DNASense's unique expertise
enables us to consistently deliver the market's highest-quality longread
data, establishing new standards for reliability and precision in
microbial sequencing. "
Naobios and Sumagen Partner to Develop
HIV Vaccine
Naobios, a CDMO (Contract Development and Manufacturing
Organization) providing bioprocess development and GMP
production of clinical batches of virus-based products, announced
the signing of a partnership with Sumagen, a Korean-Canadian
biotechnology company developing an HIV-1 vaccine candidate, to
manage the manufacturing process during its phase II clinical trials.
Financial terms were not disclosed.
At the end of 2022, the World Health Organization (WHO) reported
that approximately 39 million people were living with HIV. Developing
an HIV vaccine has been one of the most difficult challenges in
medical research, as it requires blocking a huge number of genetically
variable forms of HIV. Naobios will manage the manufacturing process
of Sumagen's whole-inactivated HIV vaccine candidate to confirm its
safety and efficacy in a Phase I clinical trial and perform further process
development to prepare the HIV-1 vaccine for phase II clinical trials.
With its BioSafety Level 3 (BSL3) production site, Naobios has the
capability to support the development and production of vaccines
for highly pathogenic viruses, like HIV, where no vaccine has yet been
identified. It will manage process development and optimization
activities for one year, after which it will support the launch of cGMP
manufacturing for phase II clinical trials.
" We are very happy that Sumagen's HIV vaccine project, which had
been delayed due to the COVID-19 pandemic, has resumed. As this is
the long-awaited resumption of production, we will make every effort
to initiate phase II clinical trials as soon as possible, " said Jung-Gee Cho,
CEO of Sumagen.
" As Sumagen's AIDS vaccine requires very sophisticated technology
and a high biosafety level facility, it was very difficult to find a company
pharmoutsourcing.com | 39 | April/May/June 2024
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Pharmaceutical Outsourcing Q2 2024

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