The biomanufacturing industry makes products that sustain and improve life for many people. But creating vaccines, medications and therapeutics requires the right ingredients at the right time. The pandemic is rewriting how many companies do business. Whether securing raw materials, working with clients or training workers, the industry is evolving. 商业北卡罗莱纳杂志, along with North Carolina Biosciences Organization, invited six leaders to discuss their industry’s current status, 它最大的需求和它的发展方向.
BioNetwork顶点中心, BTEC, 富士胶片Diosynth生物技术, Nexsen Pruet and North Carolina Biosciences Organization sponsored the discussion.
北卡罗莱纳的业务 Publisher Ben Kinney moderated the discussion.
The transcript was edited for brevity and clarity.
What makes North Carolina so attractive to biomanufacturers? 为什么它们会在这里茁壮成长?
GILLESKIE: The industry’s workforce includes technicians and mechanics along with scientists and engineers. No one educational institution can provide them all. So, NCBioImpact — a consortium of community colleges and universities that’s focused on workforce development — is a big selling point for the state. If I’m the CEO of a biomanufacturer, my biggest concern is likely staffing. North Carolina is in as good a position as any place in the world to meet that need.
瓦格纳: 我在默克公司工作. After we chose North Carolina for our new plant in 2004, I was called to company headquarters. Representatives from Georgia and Virginia wanted to know why they weren’t selected. All three economic development packages were similar; it came down to NCBioImpact and the investment to train and sustain a workforce. 他们一致认为北卡罗来纳州做得更好. Brick and mortar can be done anywhere, and somebody will always offer you as much or more money. 但这个行业是GG电子手机版下载人的. 在2.m. 一个周六, when you’re running a batch worth a million dollars, 你不用为每小时节省1美元的工资而担心. You want the person who will make the correct decision so you don’t lose it. We care about labor costs but having qualified workers is most important. You can automate all you want, but you still need qualified workers to run your operation. 北卡罗莱纳州已经在它的人民身上投资了. Look at its economic history — tobacco to textiles to technology to biopharma. 它的劳动力已经发生了变化, retraining to meet the needs of the industries that are working here right now.
EDGETON: North Carolina has had incredible foresight over a long period of time for growing this industry by building a strong ecosystem. When we talk or work with site selectors, we’re not only the Biotech Center. 我们是全州范围内的合作伙伴. It’s a collaborative effort, something we hear from recruiters that many other states lack. We’ve driven down the corporate tax rate, which makes us more competitive. We’re fortunate to have four 水平-one research universities. They generate an enormous economic impact and many ideas. 那里的生活质量很高. I love talking to people from companies overseas who once worked in North Carolina. If they could move back, they say their family would pack immediately. 你喜欢听到这种背书.
罗伯茨: North Carolina’s sustained commitment to the industry. 我们在多个州工作，所以我可以比较. 大学系统, 社区学院制度, various collaborations and financial support from the legislature have all helped the industry.
罗伯茨: 这是GG电子官方软件下载的客户的弹性. We’re more than a year into the pandemic, and there has been growth during that time. They turned economic and health threats into opportunities. 有很多公司转向的例子, such as manufacturers converting production to hand sanitizer or personal protective equipment. We heard many questions about procuring or selling PPE.
VANNAIS: The pandemic affected operations and changed our employee safety programs. Things changed quickly in the first three to six months. It was challenging to keep operations going while implementing COVID countermeasures such as adjusting shifts, 增加社会距离, 需要戴口罩或更多. We responded to individuals who had health concerns for themselves, 他们的员工, 他们的家人和同事. It was tremendously helpful to have occupational health nurses on-site supporting our organization. 我们制定了应急计划, including training people as backups to ensure batches that were in process could be completed. Then we could pause until everything was ready and everyone was healthy before resuming production. It took a 115% effort and dedication to 关闭 gaps, including sending data to clients off-site who usually are on-site during critical process validation batches. 作为一个基于客户的组织, 与客户建立信任是我们的核心价值, 在这充满挑战的一年里，我们依靠的是什么. Transitioning some functions to videoconferencing is fine. 然而, 其他功能, such as being in a manufacturing suite or laboratory, 继续与对策. 我们一整年都在进化. 我们吸取了教训，其中一些教训将继续存在. We also learned that some things have to be done in person such as training new employees. 去年我们接待了100多人.
GILLESKIE: It was a year of change for BTEC, which offers courses to N.C. 状态 students and professionals and operates a variety of labs and a simulated good manufacturing practices manufacturing area. 这一切都在2020年3月戛然而止.C. 状态 limited the number of people on campus and courses went online. We were forced to change our hands-on mindset and quickly create a virtual lab experience. I can’t say virtual labs are better; I look forward to the return of hands-on labs, 从最近的春季学期开始. But the move made us question if all our offerings had to be hands-on. 我们找到了在线课程的机会, 特别是对于专业人士, 一年前我们是不会考虑的. And we’re getting better at it now that we have demonstrated that we can do it. There’s demand: Several companies have requested online training. We’ll continue our hands-on approach and post more quality content online, 让我们接触到更多的人. In addition to online training, we partnered with other organizations in producing hand sanitizer. 我们供应N.C. 状态. And I would say there’s a better understanding of biopharmaceuticals, particularly vaccines. 我们对学生进行疫苗生产培训, and I am now in the position to discuss current events and biopharmaceuticals in class. 一年前我可不这么想.
ISENHOUR: The biggest challenge for us is envisioning what education will look like moving forward. Much of our training revolved around clean rooms and other equipment that was on campus. We were trying to create a more immersive environment for our students and industry partners. That disappeared quickly as industry focused on maintaining their outputs. 所以，我们开始研究虚拟学习. Many of our industry trainers retooled, becoming online-learning specialists. 我们的合作伙伴对这种转向表示赞赏. 生物网络的一个分支从事数字学习. It was a piece of the training puzzle before the pandemic. 现在这是一个很大的难题. 公司会希望我们保持虚拟吗, go back to in-person or create a hybrid of the two moving forward? That’s a question that all secondary educational entities are pondering. 我们必须听取行业的意见. 我们现在就在做.
EDGETON: The state deemed the industry essential, so production and operations continued. 在过去的一年里，增长非常迅速. 我们两年前做了一个研究. Based on interviews with the industry’s 58 largest employers, 我们需要5个,000年,7,在接下来的5年里，将有1万名新工人. 去年我们宣布了2800个新工作岗位.
瓦格纳: 这些工作(收入丰厚)而且稳定. Hiring 1,000 people is a billion-dollar investment. You don’t move that quickly, as some industries do, chasing $1 an hour less pay or similar things. 这些公司的领导者都很聪明. They figured out how to operate during the pandemic. 但它们的过程是复杂的. Workers are worried about their families and their co-worker who sneezed. Those are distractions, and the more workers are distracted the greater the risk. 你不能放松警惕. 这就像开车时发短信. You may get away with it 10 times, but the 11th time is catastrophic. So management and supervisors on the factory floor played an important role, 让员工专注于工作. Our role was advocating for biomanufacturers and helping them interpret new rules and their unintended consequences, which could be catastrophic in a manufacturing environment. 大流行将使企业变得更好. Weak points and opportunities have been uncovered. The challenges came with supply chain backward, where companies have less control. This isn’t an industry where you can change suppliers because your regular one is out of stock. 供应商必须经过验证. The pandemic pointed to the importance of securing your entire supply chain. 对关键材料的需求增加. Inventory 水平s are usually high, ensuring companies are covered for the short term. And the government has stockpiles of some critical materials. 但过去几个月, 你依赖于正在进行的生产, 在大流行期间，哪些方面受到了挑战. I never experienced anything like this in my 10 years running a plant. 这就像飞行员. 他们一直用自动驾驶仪飞行. But when they don’t, you want an experienced person at the controls.
How did the pandemic affect the industry’s supply chains, short and long term?
GILLESKIE: The pandemic has made sourcing raw materials and consumables a challenge. BTEC has had a difficult time getting its hands on materials needed to run labs. Much of the supply chain has been rerouted to COVID vaccine production.
VANNAIS: In 2020, we supported more than 50 different projects in North Carolina. One of them is the manufacturing of the Novavax COVID-19 vaccine candidate. Since July, we have been manufacturing 24/7 under management and support of Operation Warp Speed. 这包括对供应链的现场帮助. That was vital, because we needed every component to run each batch. But with all COVID-19 therapies and vaccines drawing from that supply chain, it is and will continue to be a challenging situation. You must have everything on hand before you start a batch. 你不会一开始就有风险. So a single consumable, a single salt, the media can prevent a batch from starting. There are many places where a supply chain delay can impact production. 过去许多物品都是单一采购的. Do we want to continue that way or should we find alternatives, 有资格的两个或三个供应商或系统? 那会增加冗余. We’re evaluating if that’s the new business model or simply a midterm plan until the supply chain is restored.
瓦格纳: Everybody will think everything is fine once we’re out of the pandemic. 但是会有一个延迟. There are buffer inventories at every link in the supply chain. 但当他们受到压力时，他们就会筋疲力尽. 重新填充供应链需要很长时间, so some critical components will be hand-to-mouth for a while. 在大流行开始后不久, 当情绪高涨时, everybody was surprised at how reliant we’ve become on China for some critical items. What happens when it’s back to business and that emotion disappears? 当有情绪的时候，成本不是问题. 但成本很重要——这就是现实. 当尘埃落定，头脑冷却, there should be some deep analysis around sourcing of critical components. Large corporations chase buying power, but sometimes the cheapest isn’t always the best. 他们也不把重点放在寻找本地供应上. And in situations such as the pandemic, that can be valuable. 你可以去坐在别人的桌子上, 给他们施加压力, 而不是无视你的电话. An expansion of local suppliers could be a boon to the state.
罗伯茨: There’s a political push for repatriating supply chains. 我们有几个客户正在研究这个. 我们看看是否有可能. 成本将是决定因素.
How is workforce training evolving to meet the industry’s needs?
ISENHOUR: The community college system and industry have a dynamic partnership in which the former customizes training using the latest technology to the latter’s needs and goals. 这不是你在任何地方都能找到的东西. 大部分的研究和开发, clinical trials and lab-based roles are found west of Raleigh, 包括三角研究园. Most of the manufacturing is done from that point east. When I worked at Johnston Community College, I mapped the state’s major biomanufacturers. I wanted to see where my students could work and our training would be needed. Within an hour’s drive — which most people would make for a good job — is 75% of the state’s biomanufacturing. 主要的高速公路, 包括40号和95号洲际公路, 连接这些公司和他们的社区, 包括威尔逊, 克莱顿, 格林维尔和四橡树街. They also connect both ends of the industry — scientific and manufacturing. Wake Tech只有一个学位, but you can’t get all that training to meet both lab technician and manufacturing skillsets in one two-year program. So, we let biotechnology remain the traditional pathway to lab and scientific careers and offered that on the county’s western side. On its eastern side the focus is manufacturing, so we target our new degree there. 你必须是区域性的. 你必须看需求. It’s about the partnerships and listening and being strategic about how you place programs.
GILLESKIE: 这是一个很好的拓展机会, 传播生物制药行业的消息, 它生产的产品, 在北卡罗来纳州流行, 以及它的经济和社会影响. N.C. 状态 students usually start taking courses at BTEC as juniors or seniors. So, we reach out to freshmen and sophomores to recruit them into our program. There will be a big emphasis on vaccine manufacturing over the next few years. In addition, gene therapy, which has taken off here over the last five years, will continue to grow. Educational institutions need to be prepared for that. BTEC has recently added manufacturing of gene therapies to its capabilities. That capability wasn’t crucial when BTEC started 14 years ago.
VANNAIS: We need to find students from middle school through college. We need to find people who want to change careers. 例如，那些离开军队的人. We need biopharma engineers and mechanics to work on large centrifuges and large 20,000L bioreactors. We’re building the largest end-to-end cell culture facility in Holly Springs, 哪个将是高度自动化的. We need automation engineers and many other professionals and trades. Some of them might not be someone who traditionally signs up for a BioWorks program. During site selection for our new facility, workforce development set North Carolina apart. Over the coming years, hiring more than 700 colleagues will not be easy. The biopharma industry is a small community in the RTP region. Knowledgeable workers are moving within it; however, retention is critical for building workplace culture and increasing efficiency. When workers move in and out of a company, it has a hard time embedding and sustaining its culture. 我们想要接触到更广泛的受众, filling jobs with community college and university graduates and people coming from other states.
EDGETON: This year will bring growth and a continued emphasis on cultivating talent. Interest in relocating to or setting up shop in North Carolina remains strong. There’s a lot of work to do on talent development. 我们启动了生物就业中心, promoting the life-sciences sector’s good jobs to K through 12 students and those in community colleges and universities, 最终是Ph.D. 水平. We also worked with partners in Durham to start BULLS: Building Up Local Life Sciences, 哪一个是接触到社区, 强调就业信息. The opportunities are promoted on Durham buses right now.
罗伯茨: We should see more growth and collaboration among biomanufacturers and life-sciences companies. Some of this collaboration has already started happening in response to the pandemic and includes working together on supply chains and even working with folks that are in different sub-industries. 一些行业协会为此提供了便利. 这种合作令人兴奋.
瓦格纳: There will be tremendous pressure to train more workers and on the state to pay for it. Everybody likes to get the jobs, but they bring responsibility. 我把默克公司带到这个州的时候, 决定因素是劳动力发展, including the Golden LEAF Foundation’s investment in NCBioImpact Network, 其中包括BTEC, Biomanufacturing Research Institute and Technology Enterprise at N.C. Central University and 社区学院制度’s BioNetwork. The industry’s employment numbers jumped in the mid-2000s then stagnated for a while. 我们现在看到了海啸. ■