Life Sciences Horizons Brochure 2025 - Flipbook - Page 6
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2025 Horizons Life Sciences and Health Care
Decentralized manufacturing considerations for cell and gene therapies
Manufacturing and supply chain models for cell
and gene therapies (CGTs) are currently complex and
expensive. Entities that can scale-up and scale-out
the manufacturing and distribution in a cost-effective
manner will be market leaders as CGTs become the
pharmaceutical industry’s “new normal.”
Agreements with decentralized sites should set clear parameters
for a successful technology transfer and measures for managing
manufacturing capacity. A patient-centered approach to
manufacturing capacity is required and will need to align with
patient scheduling and treatment administration. Robust
systems need to be harmonized and operate across the full
bandwidth of potential customers/treatment centers to manage
time-sensitive ordering protocols and capacity constraints.
Conventional supply chains, where patient cells must be
transported to a manufacturing site, processed, and returned to
treatment centers, pose various challenges for CGTs, including
manufacturing and supply bottlenecks, heightened risks of
batch rejections, and high costs (partly due to cold-chain
transport requirements). Costly supply chains mean high price
points, making reimbursement in relevant markets less likely.
Particular challenges apply for the implementation of POC
models where CGTs are manufactured at treatment centers.
Many specialized treatment centers are not equipped to
manufacture finished medicinal products on a commercial
scale, and some points of care are increasingly resistant to
adopting any on-site risk or operational responsibility for
production.
In response, there is recognition that a shift towards
decentralized models, where production takes place at or
near the point of treatment, is needed. Larger pharmaceutical
companies that adopt this approach could have significant
annual cost savings. Decentralization models can include:
In addition, the negotiation of CGT-related contracts with health
care organizations (HCOs) can be lengthy and challenging. For
example, German HCOs often ask for very particular contractual
terms and are generally unwilling to take on any substantial
financial risks or liabilities.1 We anticipate HCOs taking similar
approaches in other jurisdictions. Contracting with much more
customer-friendly and commercially experienced private CMOs
may be preferable when working towards decentralizing CGT
supply chains.
setting up facilities at treatment centers (point of care (POC)
model);
setting up manufacturing facilities near treatment centers; or
appointing a contract manufacturing organization (CMO)
with facilities near the treatment center.
At present, most manufacturers with approved CGTs on
the market still rely on centralized models, resulting in the
challenges mentioned above. The radiopharmaceutical industry
has already shifted to decentralized manufacturing to overcome
the logistical challenges associated with products with a very
short half-life (typically hours). CGT companies could look
to the radiopharmaceutical industry for guidance (although
requirements for manufacturing sites in the CGT space are
different than those for radiopharmaceuticals).
For those wanting to adopt this approach, a central reference
(i.e., manufacturing) site should be established and control
strategies put in place to ensure decentralized sites follow the
same production process as the central site. A quality protocol
will also need to be developed to ensure harmonized standards
across the sites.
1
See Planning contract negotiations with treatment centers in Germany article on page 41
Mike Druckman
Partner
Washington, D.C.
Penny Powell
Partner
London
Dr. Benjamin Goehl
Senior Associate
Munich
Sally Gu
Senior Associate
Washington, D.C.
Alexandra Wood
Associate
London
