For a Biopharma Giant like Pfizer, there is always limited production capacity and therefore a need to outsource much of its manufacturing, Fi Alonso, Senior Director of External Supply at Pfizer said at yesterday’s BioProcess International European Summit in Dusseldorf, Germany.
While Pfizer’s core abilities such as cell banking, purification development and process optimisation will always be kept in-house, the company outsources routine production of drug substance and product, and certain facility concerns, as well as services including stability and release testing.
“There is no perfect CMO, this is a myth,” she told delegates, “but if you have to rely on a [third party] manufacturer, if you pick the wrong one you are done for.”
Therefore “the CMO selection process is the most critical step in externalization,” she said, with the firm looking for a partner that fulfils its six guiding principles: quality, time to proof-of-concept, cost, risk, flexibility and adaptability (in order of importance).
For every prospective CMO, Pfizer completes a screening process, Alonso told the room. Vendors with poor financial stability or serious litigation issues are an instant “no-go" as are those that depend on a single client for most of their revenue.
“This is because we did encounter one small CMO which had about 60% of its revenue from one customer, which is kind of dangerous from the standpoint that they could fold if something happened to that particular customer.”
However, many other factors are also part of the screening process, with Pfizer looking at factors surrounding the CMO’s profile, management set-up, quality and capabilities/experience.
Geographic reach is a another consideration according to Alonso, who explained that one promising potential CMO had lost points because of its location.
“There was one CMO where we arrived at the airport, then there was a train ride, a subway ride, a train ride" he said.
Selecting an mAb manufacturer
As a case study, Alonso described Pfizer’s hunt for a manufacturer to produce commercial quantities of a monoclonal antibody (mAb). The company compared benchmark costs (Pfizer’s internal costs, standard external costs and initial set-up costs) across several markets and then selected nine CMOs – three in the US, three in Europe and three in emerging markets – to undergo its vendor screening process.
Finally Pfizer picked one in the US (the most expensive of the three at just under $4m) and the cheapest of the three in the external market (just under $2m), which both have their own strengths and have developed into strategic partners.
“[The emerging market CMO] was very strong on process analytical formulation, but less experience in the GMP space, but we have now used [the CMO] for other purposes. The US firm was very strong on the GMP part, so we’re actually utilizing that CMO currently.”
Perfect marriage or polygamy?
Alonso described the CMO-client relationship in terms of a courtship through a request for proposal (RfP), potentially turning into a marriage contract forged with a master service agreement (MSA).
However, in Pfizer’s eyes such a marriage could be tested through many more projects (“or anniversaries”) leading to a strategic partnership, or – if all goes wrong – a divorce, to terminate the contract.
Despite this analogy, when asked, Alonso admitted Pfizer had actually inked an MSA with each of the seven unsuccessful CMOs tested in the mAb example above in order to ensure capacity would be available for its biologics programme, leading to one comment from the audience implying that when it comes to CMOs, “perhaps polygamy can be more fun.”