From the Editor: Business Operations

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This special summer issue serves as an “expression platform” for as many different industry voices as we could squeeze in between our front and back covers. To get even more points of view than our authors could provide, we used a reader survey. Results elucidated in this Business Operations section continue to outline broadly the current working environment of some 200 readers who responded by focusing on staffing/training, outsourcing/partnering, data management, regulatory compliance, and sustainability.

In this section, BPI editorial advisor Jared Auclair shows how vocational schools and the biopharmaceutical industry can collaborate to build a future workforce. Consultant Filippo Pendin overviews the commercial journey of outsourced biologics. Oklahoma State University professor Sunderesh Heragu highlights opportunities presented by current supply chain challenges. BPI managing editor Brian Gazaille discusses industry 4.0 acceptance and implementation with consultants from CRB Group. Authors from Richter-Helm BioLogics describe end-to-end development and manufacturing services for microbially derived products. And finally, Balu Guduri describes Tosoh Bioscience’s approach to improving the sustainability of downstream-process operations.

Your Voice Here

Demographics: Nearly a fifth of our survey respondents chose the business-operations path in our survey. We had representation from management, business development, marketing/sales, regulatory affairs, information technologies, human resources, and regulatory affairs. We summarize the associated survey questions and answers below and thank respondents for their participation in this “expression platform.” Note that percentages are rounded off to the nearest whole number, and some questions allowed for “check all that apply.”

When we asked about industry experience, the answer with the most representation was “over 20 years” at 26%. Note, however, that the industry is skewing younger/newer overall, with 23% reporting 5–10 years and 22% reporting under five years. The midrange of 10–15 and 15–20 years came lower on the curve with 18% and 11%, respectively. Our readers are fairly mobile as well, as nearly half of them (47%) reported a job change within the past three years. Another 22% have changed employers between three and six years ago, and 15% between six and 10 years ago. A significant minority has remained company loyal, however, with 18% staying put longer than a decade.

Antibodies and derivatives continue to dominate the biopharmaceutical business, with 51% of our respondents’ companies working on them. We were somewhat surprised to find cell/gene therapies edging out all other options at 40%. Over a third (35%) are working on vaccines; fusion proteins and conjugates were tied at 33%, and 30% of respondents reported their companies to be working on nonantibody proteins. Over a quarter (27%) are involved in biosimilars, and a combined 10% reported working with tissue therapy, regenerative medicine, academic research, facilities and engineering concerns, or technology development.

A majority of respondents face continuing supply-chain concerns as we put the COVID-19 pandemic behind us. Only 11% of respondents said that they were seeing no problems; 60% reported “some,” 19% “quite a bit,” and 10% “a great deal.” Clearly the industry as a whole is not experiencing smooth sailing.

However, we did find some good news when we asked how important environmental sustainability has become to company operations. Only 14% of respondents said that it was a nonissue, with the remainder saying it’s at least “somewhat” important. Fully 38% called it very important — a sign that companies may be getting beyond lip service and making sustainability a priority.

We asked about difficulties encountered in trying to meet regulatory expectations. Over half of respondents (54%) highlighted a lack of harmonization across jurisdictions — despite the continued efforts of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the World Health Organization (WHO). Over a third of respondents (38%) lamented a lack of compliance experience on staff; documentation requirements and expenses associated with necessary testing each were challenging for 35%. Over a quarter (27%) decried a lack of available guidance (likely a common problem for those developing advanced therapies), and the same number highlighted a concern over different reviewers focusing on different aspects of compliance. Nearly as many (23%) reported a lack of communication with regulators. Only 15% found that available guidance conflicts with current technology/science, and under 10% have experienced partners disagreeing on compliance-related issues.

Outsourcing and Partnering: Speaking of working together, over half (55%) of our survey respondents said that their companies are involved in multiple licensing/partnership agreements — a number that could be higher because 17% were aware of but not directly involved in collaborative work. Another 17% said that their companies have one such deal in progress — a likely situation for small start-ups. Only 10% of survey participants reported no such relationships.

When asked which activities their companies were most likely to outsource, our readers indicated a wide array of contract work. Nearly half (48%) of their companies outsource drug-product fill–finish, and nearly as many (44%) send out drug-product formulation too. About 40% engage contract research organizations (CROs) for clinical testing, and 36% work with contract manufacturing organizations (CMOs) for drug-substance manufacturing. Over a quarter (28%) even outsource upstream and downstream process development as well as viral safety/microbiology testing. Nearly a quarter (24%) contract out their preclinical testing, and the same number reported outsourcing of analytical/quality activities. One in five (20%) go to outside experts for analytical assay development and for process validation, but only 12% look outward for discovery/developability testing. Among the activities highlighted by the 16% who checked “other” were regulatory submissions and safety testing.

Automation and Industry 4.0: We wondered what readers thought about using artificial intelligence (AI) to assist in biopharmaceutical development and manufacturing. Only 15% of respondents were concerned about security of operations and intellectual property. Most companies are interested, with nearly half (45%) of respondents saying that AI could be useful in the future but has no significant utility at this time and about the same number (44%) saying that it provides important tools that are making a difference today. Among those who are “all in” were the 17% who said that AI already is critical to operations (and those who don’t implement it will fall behind). Specific comments were cautiously optimistic, highlighting tools in development for process development and chemistry, manufacturing, and controls (CMC) while also wondering whether the use of AI “could lead to a loss of staff qualification.”

When asked specifically about the impact of biomanufacturing 4.0, our business-minded readers seemed to be a bit more wary. Over a third (37%) say they’re not using any of such technology and have no plans to. Nearly as many (30%) are using some but for a limited number of applications, and 20% reported but expecting to implement 4.0 strategy in the future. Just 10% already are using these new technologies in a transformative way that assists in daily operations.

A number of obstacles stand in the way. Business readers especially highlighted regulatory concerns, the learning curve related to software/control systems, and training/hiring for necessary skills in a three-way tie for top of mind (48% each). Capital expenditure and management buy-in both came in at 40%; the ability to customize software and the reliability and accuracy of software/control systems concerned 36%. Nearly a quarter (24%) questioned the ability to customize hardware, but only 4% reported a limited number of options available.

Human Resources: We were surprised to find that fully half of companies represented in our survey are actively hiring support staff. Less surprising is that 41% of respondents’ companies seek to add process engineers. Executives, statisticians, quality personnel, and data analysts each come in at 23%. Trailing at 14% each are information technology (IT) specialists, manufacturing-floor technicians, and managers. That three-way tie might reflect the relative stability of directors and department heads in their jobs and experience — while suggesting that automation could be aiding in the IT and manufacturing areas particularly. Open positions are getting filled pretty quickly, most within weeks or a few months. Only 15% are taking over six months, and very few (4% each) take either a few days — perhaps accounting for internal transfers — or over a year.

Are companies leveraging automation to address talent needs and shortages? The answer appears to depend on the type of work being automated. Over a third (38%) of respondents said that automation helps to streamline work but doesn’t change head count. Nearly a quarter (24%) admitted that it allows fewer people to do the same amount of work. But 17% reported no talent shortage while 14% noted no significant use of automation. Just 7% suggested that it might lower labor requirements in one area but increases them elsewhere.

Editors’ Perspective

At the 2023 BioProcess International Conference in Boston, MA, BioProcess Insider editor in chief Dan Stanton moderated a discussion panel including Renaud Jacquemart (chief executive at Omnium Global), Andrew Harmon (strategic consultant with Latham BioPharm Group), and Jeffrey Baker (strategic advisor for the Massachusetts Institute of Technology’s Center for Biomedical Innovation). They addressed a number of topics that we presented in our survey along with some capacity, funding, and other business issues.

Harmon pointed out a near doubling in the number of contract development and manufacturing organizations (CDMOs) operating in the biopharmaceutical sector between 2018 and 2022. The pandemic catalyzed such growth, with a flood of investments that came and went — followed by the inevitable global inflation. “Money’s hard to come by right now,” said Jacquemart. “Issues with workforce and supply chain, all these compounding factors have created the perfect storm. And it’s putting a dampener on innovation and slowing timelines.”

Baker countered with some good news: “The number of new-product launches is unprecedentedly high even after COVID. The number of [regulatory] submissions is unprecedentedly high. The number of supplements for deployment of new manufacturing sites is at an all-time high. We’re up to almost 50 biosimilars” [approved globally].

Jacquemart noted that government money hasn’t gone away, highlighting a vaccine project in West Africa that’s funded by US, EU, and other international sources. Infectious disease, in particular, is an aspect of national security for everyone. “I’ve been in biotech over 30 years,” Baker observed, “and I don’t ever remember the White House saying this is a national priority.”

A substantial amount of government money, Jacquemart pointed out, has gone toward training a biotechnology-ready workforce. Companies need operators who know how to assemble single-use equipment — and have found themselves hiring plumbers who need to learn quickly about good manufacturing practice (GMP) concerns. Meanwhile, with so many new CDMOs popping up, employee retention can become a concern. Harmon said that the biopharmaceutical employment market has shifted to favor workers, which is the situation in most industries now.

“I think we’re in a workforce crisis in biomanufacturing,” Baker admitted. “Talent management is a verb, not a noun, and somewhere along the way it became a noun. We’re using 20th-century constructs, but in the 21st century, it’s less about being qualified and more about being highly suited. Veterans who don’t have degrees in biology do know what ‘right first time’ means.” He pointed out the problem with the word workforce itself, which brings to many modern students’ minds the image of an assembly line. That doesn’t appeal to those who are interested in innovation and making a difference in people’s lives. “We no longer are in an apprenticeship environment. It’s about being interdisciplinary, adaptive, highly suited, highly productive, and under stress — and most importantly, right first time. And that’s not always on the resume.”

Even so, Stanton noted, a number of layoffs were announced in 2023. And although those can be disruptive to people’s lives, they also can lead to opportunity. That’s especially the case, as Baker said, for those in a region with many other biotechnology companies. He also pointed out that facility expansions don’t always get the same media attention as layoffs (and that many expansions are in progress).

Harmon said that the data show a reversal in the wave of job losses that especially swept through suppliers after the pandemic. Being located in a biotechnology hub helps, he indicated, but remote working has expanded opportunities for mid-level workers who don’t need to be present in a laboratory or on the manufacturing floor. Meanwhile, start-ups that bring jobs to new non-hub areas can benefit from government and other types of help — even though culturally, manufacturing jobs aren’t necessarily considered to be exciting.

“Companies that are real about sustainability have no issue in hiring for manufacturing,” Jacquemart offered as an example of the changing business environment. “They have no problem hiring because that workforce has changed. People want their life to mean something.”

The final word was normalization — as in finding a new postpandemic normal. All the panelists agreed that things will never go back to the way they were before. “COVID was the great magnifier,” Baker said. “It didn’t bring us a lot of new problems; it accelerated and amplified those that were already there. Supply chains that were robust have rebounded. Do we have the courage to create a new normal rather than desperately hoping that 2017 comes back?”