WHAT ARE THE THERAPEUTIC AREAS WITH MOST GROWTH POTENTIAL?
In the injectable world, the therapeutic areas with the most growth potential are multiple sclerosis, diabetes, HIV, and oncology.
Indeed, the requests we get are mainly for finding the most convenient drug-delivery system for these areas.
WITH MORE ADVANCED PREFILLED SYRINGES, IS COST AN OBSTACLE WHEN CONSULTING WITH CLIENTS?
Initially, cost is not an obstacle, but it becomes a point of heavy discussion in later stages. First, companies need to understand
the technical challenges involved in the project. How long does it take? What are the benefits? What is the optimal drug-delivery
solution from a patient's point of view? As soon as the client knows exactly what solution or option they want to pursue,
they ask about the cost and begin weighing up the benefits.
We try to make our clients aware that it's the total cost of doing business that's important. It's also vital to consider
the robustness of the supply chain, as well as quality. Whenever the supply chain or quality become disrupted, cost is usually
no longer an issue as companies are willing to do whatever it takes to mend the situation.
ARE CLIENTS PLACING ANY PRIORITY ON ENVIRONMENTALLY FRIENDLY SOLUTIONS FOR THE DISPOSAL OF INJECTABLE SYSTEMS?
Looking back over our consultations during the past year, there is usually a small discussion about a product's environmental
impact, but it's not really a major concern. It's not that companies are ignoring the issue, but there is huge pressure on
too many other factors.
SUPPLY CHAIN SECURITY IS ONE OF THE TOP ISSUES OF CONCERN ON PHARMA COMPANIES' LIST. ARE YOU INNOVATING IN THE AREA OF TAMPER-EVIDENT
SYSTEMS?
We offer the opportunity for tamperevident features, but not all companies use these. In general, we find that it's not the
main priority, but discussions about it can fluctuate. If three or four tampering cases appear in the press then every discussion
we have will involve tamper evident systems.
HOW ARE YOU PLANNING TO DEAL WITH THE LATEST TRENDS IN THE PREFILLED MARKET?
The world of injectable processing and syringes has a lot to do with the materials used. At the moment, siliconization is
important so we're continuing to optimize this process by, for example, defining the optimal degree of siliconization that
matches the active ingredient.
Another issue is the stability of all the compounds used. Glass breakage, in particular, is a big topic. It has always been
an industry issue, but has extremely high visibility at the moment because the FDA is giving it a very strong focus. To deal
with this, we have intensive discussions with all suppliers along our supply chain to finding ways of reducing glass breakage,
such as by making the glass components more optimal for use with combination products. In parallel, we have increased the
number of our automated visual inspection systems to help detect and minimize glass breakage. We're putting programs in place
and are considerably increasing our quality teams.
FDA's view has changed quite rapidly compared with the past. With FDA's 2007 Safety Act, companies are requested to conduct
ongoing stability monitoring and to have risk-evaluation processes in place. The tolerance of minor defects has also decreased
significantly. If you make 6 million units and after half a year there is a report of three broken units in a pharmacy, you
need to detect when it happened and how. This requires investment in infrastructure and technology, which adds costs to the
supply chain.
Several years ago, there were clear contracts that outlined the responsibilities of the different parties involved, such as
the component manufacturer and the secondary packager. Now, however, we are made coresponsible. If there is a problem then
we have to show documented proof that we have done everything we can to resolve the matter. As a CMO, this means we have to
have dialogue with all our supply chain members.
DO YOU THINK THE INCREASINGLY STRINGENT REGULATIONS WILL CAUSE A PHASING OUT OF SMALLER CMOS/CDOS THAT CAN'T KEEP UP?
If you look at press releases from the last year, you'll notice that FDA has put out a number of serious observations to manufacturing
organizations that can't keep up with quality standards or new regulatory expectations, leading to market recalls, for example.
If you look at the number of events that have happened globally, companies who have not been able to correct their problems
have been severely punished from a financial perspective.
This is where the shake out takes place: the company either operates to cGMP and cGLP standards and has a future, or doesn't
and gets punished! Companies have to find the financial resources to make sure their quality systems and operating processes
are state of the art. For CMOs, there is increased pressure to do this for the client—if the CMO is producing their product,
then the client will want to ensure that the CMO can keep up with industry developments and GMP. The ones who can't keep up
will not be in the business for long.
|
