Tackling the Challenges of Biologics Development and Manufacturing

February 25, 2019

It’s no secret that biologics are a growing, promising solution to address unmet medical needs.

* The global biologics market could reach U.S. $479.7 billion by 2024, up from $231.2 billion in 2017 [TMR report]
* Different market studies show compounded annual growth rates for biologics reaching — or even exceeding — 10 percent
* Eight of the 10 best-selling prescription drugs in 2016 were biologics [That’s Nice]
* Half of all new molecular entities approved in 2016 by the U.S. FDA were biologics [That’s Nice]
* IQ4Q estimates that approximately 21% of biopharma R&D spending is on biologics development [IQ4Q]

Biologics offer distinct advantages that small molecule drugs do not, but they are far more complex to develop and manufacture.

“Biologics manufacturing can be much riskier because it requires far more planning, investment and experienced personnel to carry it out,” says Jennifer Cannon, the new Vice President, Commercial Operations Development at AbbVie Contract Manufacturing. “Biologics are temperature and light sensitive, susceptible to shearing and degradation, and not as durable and robust as small molecules.”  It is therefore critical to have the right manufacturing partner to minimize challenges as a therapy moves from discovery to commercialization.

Transparency Market Research estimates it takes an average of $1 billion and nine years to launch a successful biologic.[i] These protein therapies are derived from living animal or plant materials and must be delivered by injection — which requires investment in vial-filling and syringe packaging capabilities. Manufacturing biologics requires expertise and highly engineered specialized equipment, such as single-use or stainless-steel bioreactors to prevent cross-contamination, and innovative downstream technologies. To manufacture at larger scales requires that the equipment and facilities be specifically designed and validated for such purpose, and that sophisticated quality assurance and quality control procedures be in place.

For pharmaceutical companies that have made biologics production a part of their strategic mission, the investment in biomanufacturing makes sense. TMR reports that the top 10 pharmaceutical companies have invested more than $1.5 billion in the past five years to expand biologics capacity and R&D capabilities. BioProcess Technology Consultants (BPTC) reports that in 2016 the majority of mammalian cell culture capacity (73%), was with “product companies” — those developing biologics products, while CMOs held 14% and “excess companies” — those developing biologics and selling excess manufacturing capacity — held 13%. They predict that by 2021, CMOs will hold steady at 15% capacity, product companies will decline to 68%, and excess companies will rise to 17%. With the majority of capacity in pharmaceutical companies, BPTC sites that a fundamental challenge in the industry is, “difficult for companies without capacity to access capacity at the right time and under the right conditions.” [reference American Pharmaceutical Review article]

“So, if you’re new to biologics, you will need a CMO that offers deep technical ability, quality expertise, regulatory certainty and flexible capacity,” notes Cannon. “For AbbVie Contract Manufacturing, those capabilities have been strengthened and proven for over 20 years of development and commercialization of our own biologic products.”

AbbVie, the maker of Humira, the most widely prescribed autoimmune biologic therapy, and other innovative and effective therapeutics for unmet medical needs, has extended its biologics development and manufacturing expertise to biopharma innovators through its embedded CMO, Cannon says. This includes expertise and capacity in cell line development, process optimization, fermentation biotechnology, analytical characterization, validation, and cGMP manufacturing, as well as an understanding of the importance of speed-to-market, consistency of supply, and patient safety.

AbbVie has made a significant investment in biologics capacity, with facilities for development and manufacturing in three additional locations including Singapore, Ireland, and Puerto Rico.

“We have a complete, state-of-the-art infrastructure, with unparalleled quality teams and expert intelligence, which our sponsor partners can tap into at any time,” Cannon says. “Our breadth of services has been tested through the development of our own products and bringing those products to market.”

AbbVie’s experience in bringing biologic therapies from development to commercial production offers significant value to its CMO clients. “We’ve seen nearly every kind of problem and challenge in bringing a biologic to market, so we are well versed on how to respond to it,” Cannon says. “As you would want a surgeon who’s performed the operation a million times before, you want a CMO that’s routinely performs at the highest level.  You want to be confident we’ll get you over any bump in the road, and AbbVie is well positioned to support your needs every step along the way.”

As a leading biologics producer, we offer our third-party clients monoclonal antibody production, conjugation and aseptic fill finish (including lyophilization and syringe filling).  Inclusive of development services, scale up and commercial production.

The call for market demand for biologics capacity is expected increase, potentially creating capacity shortages by 2021, and this is where AbbVie is committed to working with its partners to ensure secure supply chains.

“We love to learn from and along with our clients,” Cannon says. “It’s great when customers bring us a technical challenge that we can invest in learning. Other CMOs, particularly those steeped in small molecule drug products, may not have an appetite for this, but we want to take these on with our extensive infrastructure, experience, expertise, and people. That’s a true definition of partnership — learning together how to make biologic drug products for patients in need.”