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Perspective On: A Drug Discovery Lab

Started up in 2000, A&G Pharmaceutical is an antibody-based drug theranostic (therapeutic and diagnostic) company focused on improving the screening, detection, and treatment of cancer as well as other diseases that affect people.

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Started up in 2000, A&G Pharmaceutical is an antibody-based drug theranostic (therapeutic and diagnostic) company focused on improving the screening, detection, and treatment of cancer as well as other diseases that affect people. Based in Columbia, Maryland, the company’s lab has 22 employees.

Co-founder and vice president of research and development Jun Hayashi, Ph.D., says there are two main aspects to the company.

“We develop therapeutic and diagnostic antibodies and they’re for our own purpose—that is, role number one, our drug development aspect,” Dr. Hayashi says. “It’s very early stage drug development that we really participate in.”

The second part of A&G Pharmaceutical is a service-oriented arm called Precision Antibody. “Precision Antibody is a service entity that many of our pharmaceutical clients use to develop their own pipelines—we provide custom monoclonal antibody development,” Dr. Hayashi explains.

It’s all about quality

Two other factors set the company apart from similar organizations.

“There are many antibody development companies out there, but something that we have that really differentiates us from other people is, number one, the speed,” he says. “We [also] make very highquality antibodies.”

By “high quality,” Dr. Hayashi explains he means “high affinity”— antibodies that are against many different parts of the molecule, which are known as “epitopes.”

“We can generate those in about thirty to forty days,” he says of the antibodies. “It all depends on the antigen and immunogenicity, but usually in about thirty or forty days we know that we have a clone.”

That process isn’t easy or cheap, but Dr. Hayashi says that A&G has a 90 percent success rate in delivering the antibody that meets a client’s specific needs, something that’s very important considering the costs involved.

“Monoclonal antibody development is an expensive and labor-intensive activity, so at the end of the day, if you do not get the antibody that works in your assay … then it is totally wasted money, resources, and effort,” he says. “Our technology, over 90 percent of the time, avoids that [waste].”

The company’s unique structure, with its Precision Antibody arm, also helps with its internal projects.

“Being a small biotech company, offering this platform technology that we have will provide funds for our internal projects as well,” Dr. Hayashi explains. “That’s the unique setup that we have and we’ve been quite successful doing that.”

Management and training

As head of R & D, Dr. Hayashi’s role is to oversee the Precision Antibody part of the company, with his work focusing on the company’s clients.

“When the client comes in with a specific project—if they want to get diagnostic antibodies or therapeutic antibodies out—then I get really engaged in the initial conversation, trying to understand the science, trying to come up with the best strategy for generating the antibody that they need,” he says. “From there, we develop SOWs [statements of work] that will be transmitted to the people in the lab.”

On the internal side of things, Dr. Hayashi is involved in the development of theranostic targets. The company also has an internal portfolio of antibodies against molecules that are involved in breast and lung cancer, and Dr. Hayashi’s work focuses on developing those antibodies as well.

“There, I work very closely with the CEO [and figure out] the first target on the molecule and have a market survey and those kinds of things, and then we will come in and aid their project by developing an antibody that meets their goal,” he says of the process.

As for education, many of A&G’s managers have a B.S. or M.S degree, while some of the R & D employees have Ph.D.s or M.D.s, and the CEO is also a Ph.D. And, of course, all new employees must go through the company’s training program, Dr. Hayashi says.

“Employees are trained and then we have all the SOPs [standard operating procedures] [where] we are training employees to do specific tasks,” he says of the training program. “It depends on the speed [at which] people learn, but usually I would say the training of people [who] are fresh out of college who have never really done any hands-on lab work … takes about three months or so.”

And what is an average day in the lab like?

“Hectic,” Dr. Hayashi says with a laugh, adding, however, that the days have a fairly simple structure: lab staff are tasked with several projects and are left to their own devices.

“Once a project starts, it goes on its own, so you just have to keep up and do certain things at certain times,” Dr, Hayashi explains, adding that the manager will keep tabs on who is doing what and how many projects are in the pipeline.

However, most of the daily activities are managed by lab workers themselves rather than by management ordering staff around. “They’re very good at keeping track of multiple projects that are going on at any given time,” Dr. Hayashi says of his lab’s employees. “Sometimes they’re handling more than ten projects at once.”

Each task also has an SOP and every step is documented and recorded, with that information being shared with clients.

“That’s very important for us, that we have a consistent performance,” Dr. Hayashi says. “Each project is different … but the basic flow of the project itself is pretty much the same.”

Dr. Hayashi notes that having a great work environment is a big part of keeping staff motivated, but the work itself is most important of all.

“It’s not just a pat on the shoulder and saying, ‘nice, nice’ and those kinds of things,” he shares. “I think the people do challenging work and at the end of the work, they deliver a successful antibody. Right there, there’s a reward. It’s not a monetary reward; it’s the reward of feeling that you accomplished the goal.”

He adds that being a part of discoveries that could save lives is also important. “I think people engaged at the lab level doing that work feel that they delivered something, especially if it’s for a large pharmaceutical company—hopefully, they [played] a small role in future drug discoveries.”

The tech

With its staff working on more than 100 external and internal projects at any one time, instrumentation—which includes liquid-handling robotics and advanced analytical equipment—is a very important part of A&G Pharmaceutical.

“All of these instruments are tied into antibody development, because when you’re looking for diagnostic and then therapeutic antibodies, just merely making an antibody against the target is not good enough,” Dr. Hayashi explains. “You really have to identify the monoclonal antibody that will target the site where it can exert its biological function or prevent the biological function.”

In order to identify the antibodies that fulfill the many requirements that clients or A&G itself may be looking for, the drug discovery lab must understand cell biology, immunology, biochemistry, and the broader sciences involved, Dr. Hayashi says.

“It cannot be just a really focused attempt,” he says. “I think you really have to understand the general biology— everything combined—and that really requires those indepth understandings of the project at various levels.”

That’s where the proper screening methods and technology come into play.

“Unlike many of the custom antibody makers that are just sending out the antibodies merely based on enzyme immunoassay, many of the diagnostic and therapeutic antibodies [we produce] cannot be captured by run-of-themill technology,” he says. “Application-specific screening must be applied to each project, and that applicationspecific screening is different from project to project.”

Over the past two years alone, A&G has invested nearly $1 million into that special technology so it can meet both its clients’ and its own antibody needs, Dr. Hayashi says.

Big challenges and enjoyment

Dr. Hayashi says the drug discovery lab’s biggest challenges are also its main goals—to figure out what is required for a client or internal project, comprehend the science involved, and deliver the antibody that is needed.

“Every project is different, and I think understanding the biology and what [the client] really needs and then delivering the antibody that meets their final goal— that is the biggest challenge,” he says. “And we do that quite well.”

Keeping up with its growing business while keeping quality high is a newer challenge for A&G.

“Maintaining that quality and then to deliver the product in a timely fashion, as the business expands, that’s really a big challenge and change,” Dr. Hayashi says. “That was also the motivation for modernizing and putting in all those robotics in the discovery platform.”

However, the variety involved in the work, along with meeting a project’s goals, is what Dr. Hayashi says he enjoys most about his job.

“Every day is different, a different challenge, and also when we deliver,” he says of his favorite aspects of his work. “When one [project] is done, you feel you’ve accomplished something and also for our internal projects … that really could be used for any of the applications outside, then you feel you’ve really done a decent job.”

Having worked in academia at the University of Maryland before officially joining A&G in 2007, Dr. Hayashi says he likes the differences of working in industry.

“I enjoy it very much,” he notes. “It’s quite different than being in academia where every project is more or less open-ended—but in industry you have to have a conclusion, and the conclusion is the delivery of the antibody that works in our client’s or our own hand.”

Major changes and looking ahead

As for what’s changed for A&G since it began in 2000, Dr. Hayashi says the company is more well-known to the pharmaceutical industry now and it also works closely with the U.S. government, making many of the antibodies for the National Institutes of Health, Centers for Disease Control, National Institute of Allergy and Infectious Diseases, and the Food and Drug Administration.

“The biggest change has been that a lot of pharmaceutical companies are using us, and also we are known in the federal government, in the research end, that we make quality antibodies,” he says. “For example, we make what we call gold-standard antibodies for cancer biomarkers for the NCI [National Cancer Institute].”

An increase in outsourcing from industry has also meant more work for A&G as other companies look to focus on other areas of their businesses.

For the future, the company hopes to continue delivering quality antibodies through its specialized instrumentation and is also getting started on a humanization service.

“The next challenge and where we are going is a sort of one-stop shop where people can start making antibodies to their targets and go all the way to drug development, utilizing our humanization service,” Dr. Hayashi says, adding they will likely get into developing fully human antibodies as well.

Dr. Hayashi couldn’t go into too much detail about the most interesting projects currently being worked on in the lab, only that he is very enthusiastic about the work being done.

“I’m quite excited right now about the things that are going on,” he says. “We are looking into new targets and also we are looking into some really neat ideas that we hope will change the face of detection in the future. I can’t wait to come to work.”

Main Instruments:

The Hamilton STAR liquid handling system is operated in the A&G drug discovery lab.