Issue: Exclusive Online Content, Posted Date: 12/22/2016
Cartridge Filling: Combination Features That Can Help Gain a Competitive Edge
By 2050, it is projected that the proportion of people
aged 65 and older will be more than double that of children aged 5. This global
phenomenon is also leading to an increasing number of people suffering from
chronic diseases, such as diabetes and osteoporosis. Combined, these trends are
making it difficult for healthcare professionals to effectively treat patients
over the long-term. Thus, increased attention is leading to a growth in
patient-friendly administration systems, such as single-and dual-chamber
cartridges in combination with a pen device.
Cartridge Systems Offer a Competitive Advantage
For pharmaceutical and biotech companies looking to
gain a competitive edge, pen injectors and cartridges offer an attractive
alternative to vials because their combination of features offer advanced
design, product differentiation, and improved life cycle management. There are
a number of drivers for a cartridge-pen combination approach to drug
administration, including a growing concern for patient safety, compliance, and
consistency, an increasing need for self-medication in the home - particularly
for chronic diseases, and a preference for differentiation.
What are the Challenges of Cartridge Systems?
Along with the many advantages cartridge systems
offer, there are challenges to be considered as development of a cartridge-pen
combination can be complex. Such systems are essentially devices that are a
combination product. As such, they bring together a number of elements,
including a drug and a device, a device and a biological product, a biological
product and a drug, or a device and a biological product. The challenges of
such systems include:
Regulatory Demands – Combination products are subject to specific FDA
regulations related to their constituent parts, which means the components must
be addressed individually. Human factor and clinical study considerations must also
be taken into account for combination products.
cGMP requirements – GMP guidance for such products must
be followed. And, as with regulatory demands, cGMP requirements apply to all constituent
The Choice of Partner is Essential for Success
When the choice is a cartridge system,
partnering with a leader experienced in developing combination
products can be invaluable when navigating the special regulatory processes.
Along with regulatory know-how, the following criteria should be considered
when selecting a partner:
- A successful
track record in cartridge development
- Capabilities in
in cartridge filling – clinical and commercial
- Selection of packaging
Also consider that because cartridges require a filling and pen assembly
solution, a single point of contact can help simplify accountability and
response from your partner.
For more information about cartridge-pen
combinations, please follow this link:
filling: Understanding the complexities or visit www.vetter-pharma.com.
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