Alcura Obtains Manufacturing and Importation Authorization License, Expanding its Capabilities to Support Cell & Gene Therapy Developers
2024年8月14日 - 8:30PM
ビジネスワイヤ(英語)
With the license, Alcura can offer import,
storage and QP Batch Certification of investigational and
commercial cell and gene therapy products
Alcura, a provider of specialized clinical trial services and a
part of Cencora, has been granted a Manufacturing and Importation
Authorization (MIA) license for cell and gene therapies (CGT) by
the Spanish Agency of Medicines and Medical Devices. The
certification, coupled with Alcura’s cryogenic storage capacity and
team of experts, enables the company to provide enhanced support to
developers planning to bring investigational or commercially
approved CGTs into Europe.
Alcura can now import CGTs — or advanced therapy medicinal
products (ATMPs) — manufactured outside the European Union (EU) via
its facility in Viladecans, Spain. The batches are stored in
temperature-controlled units while Alcura’s team of qualified
persons conduct necessary reviews, including ensuring batches are
manufactured in compliance with the clinical trial or marketing
authorization and Good Manufacturing Practice (GMP) requirements.
Once the batch is certified, Alcura will release the products for
distribution across Europe.
“Managing ATMPs requires a deep understanding of the intricate
regulatory requirements and specialized logistical support to
ensure product quality and safety,” said Javier Casas,
Vice President and Regional Director at Alliance Healthcare and
Vice President of Clinical Trials. “We continue to expand our
portfolio of solutions through strategic investments in
infrastructure and innovative services, allowing us to offer more
comprehensive support that can be tailored to our partners’ needs.
With this MIA license, we can import and release ATMPs developed
outside the EU, helping to facilitate efficient and secure access
to quality products across Europe.”
There are nearly 2,000 clinical trials underway globally,
according to the Alliance for Regenerative Medicine. In its 2024
State of the Industry Briefing, ARM forecasted a possible 17 CGT
regulatory approvals across the United States and Europe this
year.
Alcura offers a variety of logistics and regulatory services,
including importation, batch certification, storage, packaging and
labeling, export, and regulatory assessment. Alcura recently added
liquid nitrogen tanks and additional temperature-controlled
capabilities at its Viladecans facility, expanding its capacity to
hold products that require storage at frozen or cryogenic (as low
as -196 degrees Celsius) temperatures.
The new capabilities further expand the services available to
CGT developers via Cencora’s network of businesses, including
third-party logistics services, regulatory consulting, market
access and reimbursement support, clinical trial and commercial
distribution and patient services.
“The growing pipeline of cell and gene therapies offers
tremendous promise for patients worldwide,” said Lung-I Cheng,
Vice President and Head of Cell & Gene Therapy Service Line at
Cencora. “Alcura’s MIA certification reflects the commitment
across Cencora to continually elevate and expand our capabilities,
enabling us to deliver integrated support across the product
lifecycle to help our partners advance innovation and ensure they
can reach the patients who need them.”
As part of its commitment to support CGT, Alcura is hosting a
summit on September 19, 2024, “Overcoming Hurdles to Promote
Advancements in Cell and Gene Therapies,” which will convene
leaders across the industry to discuss the latest developments in
the CGT sector and strategies to support the unique logistics and
distribution requirements. For more information on Alcura’s
capabilities or to register for the event, visit Alcura’s
website.
About Cencora Cencora is a leading global pharmaceutical
solutions organization centered on improving the lives of people
and animals around the world. We partner with pharmaceutical
innovators across the value chain to facilitate and optimize market
access to therapies. Care providers depend on us for the secure,
reliable delivery of pharmaceuticals, healthcare products, and
solutions. Our 46,000+ worldwide team members contribute to
positive health outcomes through the power of our purpose: We are
united in our responsibility to create healthier futures. Cencora
is ranked #10 on the Fortune 500 and #24 on the Global Fortune 500
with more than $250 billion in annual revenue. Learn more at
www.cencora.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20240814175480/en/
Mike Iorfino 610.545.9189 mike.iorfino@cencora.com