Japan and the US). The intent of this Guidance is to define an
approach to drug development that encourages industry to
adopt more modern and innovative manufacturing technologies.
Central to the approach is the concept of “Quality by Design”
or QbD. QbD is a scientific approach that enables an enhanced
understanding of safety and control of chemical drug manufacturing processes. The approach is designed to yield more robust
manufacturing processes than that which can be achieved by
traditional approaches to drug substance development.
The EMA has also enacted new legislation to protect the security, integrity, and authenticity of drugs marketed in the EU. As
part of the new directive, starting July 2013, all active substances
manufactured outside the EU and imported into the EU must
be accompanied by a written confirmation from the regulatory
authority of the exporting country. The written authorization
statements are to be issued per manufacturing site and per active substance. The exporting country also has to ensure that the
standards of cGMP used to manufacture the API are equivalent to
those enforced in the EU.
QUALITY OVER COST
Given the significant risks and costs associated with the de-
velopment of innovator drugs, it is not surprising that sponsor
companies prioritize quality and reliability over pricing and seek
strategic partnerships over transactional relationships with CMOs.
Since innovator drugs are targeted for approval in established
pharmaceutical markets with strong patent protection, the po-
tential ROI lies in favor of quality over cost. The reason for this
is that even small delays in the development and/or API delivery
schedule of an innovator drug can rapidly wipe out any cost sav-
ings garnered from more risky lower-cost CMOs. Nonetheless,
there is tremendous pricing pressure in the current environment
to reduce the cost of development and manufacturing. Regulatory
compliance represents a significant portion of the cost of an API.
As Western regulatory agencies move to greater emphasis on
quality, transparency, and stakeholder engagement the cost differ-
ential between onshore and offshore manufacturing may narrow
even further. Conversely, as more R&D is conducted offshore and
as demand for innovator pharmaceuticals increases in emerging
markets, there will be greater incentives to develop and manu-
facture innovator drugs regionally. Since strategic outsourcing is
an interactive process, differences in time zones, culture, travel,
communication, and regulations will have to be taken into ac-
count to fully assess the “True Cost” of the outsourcing endeavor.
Experienced CMOs that can provide cost-effective pricing, sus-
tained quality manufacturing services, deliver on schedule, and
foster trusted and valued strategic outsourcing relationships will
prevail in the industry regardless of their global location.
1. BIO and BioMed Tracker “Release of BIO/Biomedtracker
Drug Approval Rates Study” BIO International Meeting: Chicago,
Il; April 22-25, 2013.
2. US Accountability Office, GAO-11-936T, Sep. 14, 2011 “Drug
Safety: FDA Faces Challenges Overseeing the Foreign Drug
Manufacturing Supply Chain.” ■
Experience makes a world of difference.
Ash Stevens has been providing the Life Sciences industry with contract
pharmaceutical manufacturing services for more than 50 years.
s;; Process research, development, and scale-up
s; Early-stage to commercial API manufacturing
s; Highly potent drug substance development and
s; Analytical development and validation
s; Comprehensive regulatory support
s; Preparation of documentation for submission
(IND, NDA, DMF, CTD)
To see how our experience can help your drug
development program succeed, call or click today.