Some biomanufacturing experts have recently begun referring to the expected growth of biologic therapeutics as an oncoming tidal wave or tsunami. Like the natural disasters these terms describe, there can be harmful repercussions — both to the industry’s reputation and the patients in need — if companies are not adequately prepared for the impending biologic manufacturing capacity crunch.
Although biologics make up a mere 20 percent of branded prescription drug sales today, this number is expected to exceed 50 percent by the year 2020. One person sounding the alarm on the importance of preparing manufacturing for this significant increase is Andy Skibo. A 40+ year biomanufacturing veteran, the EVP of biologics supply at MedImmune/AstraZeneca (AZ), and 2015 chair of the International Society for Pharmaceutical Engineers (ISPE) says using terms like “massive,” “unprecedented,” and “historical” to describe the current situation is not an exaggeration. According to Skibo, “Companies are no longer using thousand-liter multiples to describe their oncoming biologic manufacturing needs. Instead, we are using whole sites (i.e., three to five ‘Fredericks’) as measuring sticks.” The AZ Frederick, MD facility to which he is referring originally encompassed 90,500 square feet. But that isn’t the three to five times figure Skibo suggests you consider. Rather, contemplate Frederick’s more current and expanded size, 710,000 square feet (i.e., 16 acres), with plans soon to add 40,000 more. Biologics already represent nearly half of AZ’s R&D pipeline (i.e., approximately 120 with more than 30 in clinical development). As a result, Skibo is well attuned to the significance of the situation.
If you are involved in planning for biomanufacturing capacity needs at your company, Skibo recommends taking into account the following considerations. Through 2020, the CMO space for bulk bio drug substance production will be very constrained. “We are not in a time period where if we guess wrong on the low side, we can just pick up the phone and find a CMO or partner with a lot of spare capacity,” he states. “Further, pipeline accelerations have cut drug development cycle times from eight to 10 years down to three to four. However, it still takes about five years to design, build, commission, and license a large-scale bio drug-substance facility.” Committing to these major capacity builds without a confirmed need is a major financial guessing game.
One company currently involved in a major biomanufacturing capacity initiative is Biogen. Sparked by positive Phase 1b clinical trial results for aducanumab, its experimental drug for Alzheimer’s disease (AD), Biogen fast-tracked the compound straight to Phase 3 clinical trials. Imagine being faced with the prospect of being manufacture-ready to potentially serve millions of people suffering from a very debilitating disease, now under a much more accelerated time line. What would you do? This month’s cover article on p. 20 features Biogen’s top manufacturing exec, John Cox, EVP of pharmaceutical operations and technology. Cox shares his insights as to how exactly Biogen is preparing to meet its biologic manufacturing needs, including the decision to build a billion-dollar biologic facility in Solothurn, Switzerland. Interestingly enough, the word “panic” never seemed to enter into the conversation.