Pharmaceutical Outsourcing Q2 2024 - 38

INDUSTRY NEWS
Asahi Kasei Bioprocess, Axolabs Form
Strategic Partnership to Speed Up
Oligonucleotide Therapeutics Development
Asahi Kasei Bioprocess (AKB), part of the Asahi Kasei Group, and
Axolabs have announced a strategic partnership in the burgeoning
field of oligonucleotide therapeutics. The partners will collaborate
to build a cutting-edge oligonucleotide cGMP manufacturing facility
spanning an area of 59,000 square feet (approximately 5,481 square
meters) in Berlin. This cooperation aims to accelerate the development
and commercialization of oligonucleotide-based therapies to improve
quality of life for patients worldwide.
Oligonucleotide therapies offer a targeted approach to modulating
gene expression, splicing, and protein production. By selectively
manipulating specific molecular processes, these therapies hold
the potential to treat a wide range of diseases (e.g., genetic
disorders, cancer, and certain viral infections) at the genetic level,
providing new treatment options for patients. In recent years,
remarkable advancements in nucleic acid chemistry and cell
biology have contributed to refining the design and optimization
of oligonucleotide therapies, as well as their delivery mechanisms.
Currently, a total of 25 approved oligonucleotide therapeutics have
been approved by regulatory authorities worldwide, and numerous
others
are in pre-clinical and clinical studies with promising
prospects for further development.
To meet the escalating demand for oligonucleotide therapeutics,
Axolabs, a CRDMO providing drug substances for oligonucleotidebased
therapeutics, is establishing a new GMP manufacturing hub
in Berlin. By utilizing the unique expertise of AKB, specializing in the
field of oligosynthesis equipment, and Axolabs, the facility will serve
as a pivotal resource to expedite therapeutic breakthroughs in the
industry. It is designed to accommodate a wide range of production
scales (small to large/commercial) and will benefit from AKB's robust
suite of oligo manufacturing equipment-covering all upstream
and downstream manufacturing unit operations from synthesis to
concentration-all of which is purpose-built to maximize productivity
and provide years of reliable operation.
" We are thrilled to join forces with Axolabs in this transformative
endeavor. Our combined technical expertise and strategic alignment
will bolster our commitment to meet and exceed the growing needs
of the oligonucleotide therapeutics field, " said Chris Rombach, SVP of
Sales and Marketing at AKB. " Moreover, our involvement from the very
early stages of the project allows us to support and facilitate future
scale-up efficiently. "
Thomas Rupp, Managing Director of Technology & Production at
Axolabs, echoed the sentiment, " Partnering with AKB provides
a unique opportunity to blend our respective strengths. We are
confident that this collaboration will foster innovation and drive the
production of high-quality oligonucleotide therapeutics. "
Operations at the newly built facility are planned to commence in
late 2024.
Chargepoint Expands Product Range
with Multi-Million-Dollar Single-Use
Manufacturing Facility Investment
ChargePoint Technology, a specialist in powder and liquid transfer,
has invested in a new manufacturing facility dedicated to its singleuse
products in Speke, Liverpool, to address an increased demand in
the market for disposable technologies and equipment. The new site
will boast a new high-tech cleanroom alongside a temperature and
humidity-controlled storage facility for single-use solutions.
The new single-use centre of excellence is adjacent to ChargePoint's
current headquarters and will become fully operational in June 2024.
It will significantly increase ChargePoint's overall cleanroom capacity
at this location.
The investment supports a trio of product launches to meet
growing demand in the market for solutions that maintain optimum
containment and sterile integrity for closed powder transfer, for both
small and medium-scale production. These include:
* ChargeBag® XL: New 3D powder transfer bags have been
developed to increase the range of sizes available to
ChargePoint customers for batch transfers in excess of 150L
in volume in API, OSD and aseptic production. Using the
proprietary HiPure ULP7 film, the 3D powder takes the current
range of 2D bags beyond 40L capacity for the same effective
and efficient powder handling at enhanced scales.
Pharmaceutical Outsourcing | 38 | April/May/June 2024
Kühne Holding Acquires Pharma Contract
Manufacturer Aenova from BC Partners
Kühne Holding AG has entered into a definitive agreement to acquire
pharma contract development and manufacturing organization
Aenova Group from leading international investment firm BC Partners.
As part of the transaction, BC Partners' advised funds will reinvest
alongside Kühne Holding AG and continue to support Aenova as a
minority shareholder. Financial terms were not disclosed.
The Aenova Group is one of the world's leading CDMOs (Contract
Development and Manufacturing Organizations) in the pharmaceutical
and healthcare industry. Headquartered in Starnberg, near Munich,
and with approximately 4,000 employees in 14 manufacturing
sites worldwide, the company is a one-stop service provider for the
development, manufacturing, and packaging of drug products for
pharma companies around the globe.
Under the ownership of BC Partners, the Aenova Group has developed
into one of the ten largest CDMOs in the world. The company's
growth trajectory has accelerated under the leadership of CEO Jan
Kengelbach, who has repositioned the company into differentiated
and innovative growth platforms during his six-year tenure at the
helm of the Group. In 2023 Aenova delivered record results with proforma
revenue of €832m, an increase of 17% on the prior year.

Pharmaceutical Outsourcing Q2 2024

Table of Contents for the Digital Edition of Pharmaceutical Outsourcing Q2 2024

EDITOR'S MESSAGE
EDITORIAL ADVISORY BOARD
SUPPLY CHAIN - Six of the Best Methods to Spark Distribution Improvement and Innovation for the Next Decade
CLINICAL TRIALS - Toward More Intelligent Collaboration: Implementing Data in Partnerships
CLINICAL TRIALS - Leveraging Machine Learning and Deep Learning for Natural Language Processing in Clinical Data Management
CLINICAL TRIALS - Beat the Clock: How an FSP Model Can Optimize a Follow-the-Sun Approach in Clinical Development Functions
CONTRACT RESEARCH - Elevating Laboratory and Manufacturing Equipment Health With AI-Predicted Health Score
AN INTERVIEW WITH GIANMARCO NEGRISOLI, FLAMMA USA
ROUNDTABLE - Pediatric Dosage Forms
SUPPLY CHAIN - Navigating Trends and Challenges Facing Pharmaceutical Supply Chains
HORIZON LINES
INDUSTRY NEWS
ADVERTISER'S INDEX
Pharmaceutical Outsourcing Q2 2024 - Cover1
Pharmaceutical Outsourcing Q2 2024 - Cover2
Pharmaceutical Outsourcing Q2 2024 - 1
Pharmaceutical Outsourcing Q2 2024 - EDITOR'S MESSAGE
Pharmaceutical Outsourcing Q2 2024 - 3
Pharmaceutical Outsourcing Q2 2024 - 4
Pharmaceutical Outsourcing Q2 2024 - 5
Pharmaceutical Outsourcing Q2 2024 - EDITORIAL ADVISORY BOARD
Pharmaceutical Outsourcing Q2 2024 - 7
Pharmaceutical Outsourcing Q2 2024 - SUPPLY CHAIN - Six of the Best Methods to Spark Distribution Improvement and Innovation for the Next Decade
Pharmaceutical Outsourcing Q2 2024 - 9
Pharmaceutical Outsourcing Q2 2024 - 10
Pharmaceutical Outsourcing Q2 2024 - 11
Pharmaceutical Outsourcing Q2 2024 - CLINICAL TRIALS - Toward More Intelligent Collaboration: Implementing Data in Partnerships
Pharmaceutical Outsourcing Q2 2024 - 13
Pharmaceutical Outsourcing Q2 2024 - CLINICAL TRIALS - Leveraging Machine Learning and Deep Learning for Natural Language Processing in Clinical Data Management
Pharmaceutical Outsourcing Q2 2024 - 15
Pharmaceutical Outsourcing Q2 2024 - 16
Pharmaceutical Outsourcing Q2 2024 - CLINICAL TRIALS - Beat the Clock: How an FSP Model Can Optimize a Follow-the-Sun Approach in Clinical Development Functions
Pharmaceutical Outsourcing Q2 2024 - 18
Pharmaceutical Outsourcing Q2 2024 - 19
Pharmaceutical Outsourcing Q2 2024 - CONTRACT RESEARCH - Elevating Laboratory and Manufacturing Equipment Health With AI-Predicted Health Score
Pharmaceutical Outsourcing Q2 2024 - 21
Pharmaceutical Outsourcing Q2 2024 - 22
Pharmaceutical Outsourcing Q2 2024 - 23
Pharmaceutical Outsourcing Q2 2024 - AN INTERVIEW WITH GIANMARCO NEGRISOLI, FLAMMA USA
Pharmaceutical Outsourcing Q2 2024 - 25
Pharmaceutical Outsourcing Q2 2024 - ROUNDTABLE - Pediatric Dosage Forms
Pharmaceutical Outsourcing Q2 2024 - 27
Pharmaceutical Outsourcing Q2 2024 - 28
Pharmaceutical Outsourcing Q2 2024 - 29
Pharmaceutical Outsourcing Q2 2024 - 30
Pharmaceutical Outsourcing Q2 2024 - 31
Pharmaceutical Outsourcing Q2 2024 - SUPPLY CHAIN - Navigating Trends and Challenges Facing Pharmaceutical Supply Chains
Pharmaceutical Outsourcing Q2 2024 - 33
Pharmaceutical Outsourcing Q2 2024 - 34
Pharmaceutical Outsourcing Q2 2024 - HORIZON LINES
Pharmaceutical Outsourcing Q2 2024 - 36
Pharmaceutical Outsourcing Q2 2024 - 37
Pharmaceutical Outsourcing Q2 2024 - INDUSTRY NEWS
Pharmaceutical Outsourcing Q2 2024 - 39
Pharmaceutical Outsourcing Q2 2024 - ADVERTISER'S INDEX
Pharmaceutical Outsourcing Q2 2024 - Cover3
Pharmaceutical Outsourcing Q2 2024 - Cover4
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