HPLC to UPLC. The excess throughput/
capacity would configure the analytical/QC
lab to accept outside samples. The income
from the new contract analysis lab may be
used to finance newer process equipment
and monitors, allowing the contract manufacturer to become capable of performing
low impact formulation studies.
By low impact, I mean using CN equipment to perform design of experiments
for both clinical formulations and final
product. CM equipment and continuous
monitoring allows the formulator to use
far smaller amounts of raw materials and
APIs to develop the dosage form. In addition to saving materials, the time scale
from beginning to final dosage form
shrinks from weeks to one or two days.
There is also an opportunity for a number
of smaller organizations to pool resources
and develop a communal plant, either at
one of their properties or a neutral site. The
details would need to be worked out, as well
as proprietary information protected, but,
especially for companies making generics,
there would be less emphasis on secrecy.
The shared expenses would bring an
already less expensive alternative to classic formulation and production to lower
levels by assuring that the equipment
would only be used as needed, lowering
the yearly ownership costs.
Another benefit could be co-edu-cation of several members of each firm,
rather than having to support a huge staff
for each company. Mutual non-disclosure
agreements could protect each company’s interests, yet allowing the staffs to
Clients take charge
The third way is for larger companies (
clients) to simply install CM units at CRO/
CMO facilities. For a year or two, Pfizer
has been showing their modular CM
units. These are analogous to pre-fabri-cated houses, where the several pieces
are fabricated at a central location, tested
for functionality, and then transported to
a remote site. The remote sites for Pfizer,
so far, have been their own properties, not
already equipped with such equipment.
The stated purpose was to assure that
the products generated at the remote site
were nearly identical to the initiator site.
This concept could easily be expanded to
contract sites too. If the initiator company
wishes to have a CMO pick up production,
this approach would allow them to duplicate the initially submitted product with
minimum revalidation. The other benefit
is, when a blockbuster product either approaches or reaches its expiry date, the
major company could continue producing it, under its own brand name, but at a
greatly reduced price point and still make
a profit greater than producing it in their
own larger, higher overhead facility.
You might ask why the larger pharma
corporations would want potentially com-
petitive CRO/CMOs to exist, much less
pay for them to be so modern and cost-
effective. There are several truths that they
will recognize. First, when then initiator’s
patent runs out, some, if not many, gener-
ics will absolutely produce the product
and compete at a lower price. Second,
insurance companies and, by extension,
pharmaceutical companies, are coming
under pressure from governmental agen-
cies in multiple countries to lower costs.
This will be extremely painful under cur-
rent production paradigms.
What a cooperation between large
pharma, CRO/CMOs, and generics could
accomplish would be a so-called “
win-win-win”for the larger companies, smaller
companies, and the contract companies.
How could that work?
1. Using a CMO from the beginning
of a product’s lifecycle would, by avoiding the inherent overhead of the larger
company, allow the cost of the drug to be
more modest, yet allowing the originator
to make a well-earned profit.
2. This lower cost of production would
allow the parent company to produce the
product in the country in which it is being
sold, allowing the local agency to oversee
the facility and ensure a more robust supply
chain. Add to that no need for importation
inspections and savings on shipping costs,
and the prices can be even more competitive.
3. As the drug product comes off patent, the CMO with the mirror production
lines could be incorporated to continue
producing the drug under the initiator’s
copyrighted name, but at a cost comparable with generic competition.
4. If a generic or non-engaged CRO
decides to produce a product coming off
patent, the quality of that product could
well rival the original, named product.
So, point one is a win for the bottom
line of an initiator company and the CMO
involved; the former still makes money,
while the latter employs trained production and lab staff. Point two is a win for the
patients in the country where a product is
produced: lower costs and assured quality
are built in. Point three, the initiator can
continue to carry brand recognition, make
a profit, and, once again, employees of the
CRO keep their positions. Point four is
largely a win for the patients, who can use
the generics, which are often insurance
company mandated, with confidence.
So, to summarize, the spread of PAT/
QbD/CM capabilities is a win-win-win for
large, initiator pharma companies, CRO/
CMOs, and generics, and, not to be forgotten, the end user, for which the product
was, after all, intended. Of course, similar
arguments apply for large companies to
follow this blueprint for research, development, and clinical trials. CP
“With all the
incurred with orphan
drugs, there are still
engaged in making
them. In addition to
of the big boys are
outsourcing many of