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Feliza Mirasol

Hollie Barton with Thermo Fisher Scientific, discusses ways that labs are addressing the pressure of rapid analytical turnaround times.

Addressing the Analytical Challenge of Meeting Quick Turnaround Times (AAPS PharmSci 360)

Hollie Barton, senior director, Chromatographic Services, for the PPD clinical research business of Thermo Fisher Scientific, spoke with 

® at AAPS PharmSci 360 where she discussed the challenges of increased demand for longer lead times from analytical labs in an environment where clinical pressures are calling for drastically reduced turnaround times. In this interview, Barton emphasizes how one such group, BioA labs, has been addressing the need to move faster when cycle times are being determined by methodology.

“Actually, the labs are kind of taking a two-tiered approach to that. They are doing some internal and some external things. Internally, we're watching BioA labs move to 24 hour, seven-day- week work shifts [but also with] fluid shifts within that. When I say fluid shifts, we're really looking at folks to work possibly five–eight hour shifts, and then the next week possibly moved to four–10 [shifts], maybe even three–twelve [shifts], to attack [the] methodology they're having to run,” Barton says.

She also notes that project management is being added to the BioA labs. Normally, those lab personnel reside at the central laboratory or clinical sites. “What we're seeing is them being placed in the BioA lab to provide a single point-of-contact with communication that's flowing through. [That] addition has really cut down on the work that the PI [principal investigator] has to do in regard to communication and point-of-contact,” Barton explains.

This slight change has allowed labs, particularly PIs, to better focus better on the science, which is where the investigators’ attention should be, Barton emphasizes. Barton also notes that, externally, she is seeing BioA labs pushing back on contracts, especially in situations where there are no central laboratories involved. “That moves the needle in the wrong direction if you don't bring in the central lab because the BioA lab should not be performing those responsibilities,” she observes.

“We're also seeing where we've added additional teams to the back-end, externally, to better look at protocols. So, we're adding site tech teams to understand exactly what we need to be quoting and looking at. We're seeing all of those things from an internal and external push on clients,” Barton concludes.

AAPS PharmSci 360 ran Oct. 22–25 in Orlando, Fl.

Articles

Hollie Barton, senior director, Chromatographic Services, for the PPD clinical research business of Thermo Fisher Scientific, discusses ways that labs are addressing the pressure of rapid analytical turnaround times.

On Oct. 30, 2023, Aragen, a contract research development and manufacturing organization (CRDMO), announced that it was setting up a new biologics manufacturing facility in Bangalore, India as part of a $30 million investment.

The new 160,000 m2 facility will include process development labs and multiple good manufacturing practice (GMP) suites as well as supporting functions such as quality control labs (analytical and microbiology). The GMP manufacturing suites will be equipped to conduct intensified bioprocessing using single-use bioreactors and will have advanced downstream purification capability, according to a company press release.

The facility will be designed to offer integrated solutions across the biomanufacturing lifecycle—from process development to process validation, analytical development, pilot production, large-scale drug substance manufacturing, and stability services. The facility will also be equipped to develop and manufacture monoclonal antibodies, therapeutic proteins, and fusion proteins to augment the company’s bioproduction capability in California.

The process development laboratory is slated to be operational by the third quarter of 2024. The first manufacturing suite will open in the third quarter of 2025. The facility will include plasmid DNA, messenger RNA, cell and gene therapy, microbial manufacturing, and additional GMP manufacturing suites in the future to meet demand.

“With the opening of our bio-manufacturing facility, we will empower our customers with even faster development timelines and support their full lifecycle journey from clone development to cell culture manufacturing …, ” said Subodh Deshmukh, CEO, Aragen Bioscience, in the press release.

“Setting up of a biologics manufacturing facility in India is part of our forward integration strategy for our US-based biologics business, allowing Aragen to offer integrated gene-to-GMP solutions to our customers. Once this facility is commissioned, Aragen will offer a unique value proposition to our biologics customers where the early stage discovery will be executed in our R&D labs in California … As the molecule advances, Aragen can tech-transfer the program to our … manufacturing facility in Bangalore, offering better COGS [cost of goods and services] to our customers,” said Manni Kantipudi, CEO, Aragen Life Sciences, in the press release.

As part of a $30 million investment, Aragen is setting up a new biologics manufacturing facility in Bangalore, India.

Aragen to Establish $30 Million Biomanufacturing Facility in India

® at AAPS PharmSci 360, Sara Fathollahi, PhD, product application specialist, DFE Pharma, gives a summary of the takeaway message from her presentation at the conference.

“My main point … was [about] how excipient suppliers (taking DFE Pharma as an example) can support a smooth transition from batch to continuous manufacturing. I believe that the pharma industry is like a big complex puzzle. Each of us—excipient suppliers, manufacturers, machinery suppliers, universities, research centers—we are pieces of this puzzle, and we are individual pieces, but, together, we make the big, impressive image of innovation,” Fathollahi explains.

In her talk, Fathollahi showed how her company supports its customers by using excipients to de-risk the manufacturing process. “What we do is that we share [internal] … data. We have historical data of all batches that we produce and that support us [in showing] which variation the customer can expect from our material. Then, we can also select batches for them, and with [those] batches—in addition to experiments that they do on their end—they can prove robustness to the regulatory bodies,” she states.

“To give you a more specific example, let's say that the manufacturer received one, five, or ten batches from us; even though, after conducting really complete characteristics on the batches they received from us, thedata that they have [are] limited to those batches. As a supplier, we have historical data, we can really provide much more information and can give insight about which variation can be expected from our product in the next five years, for example,” Fathollahi emphasizes. In addition, DFE Pharma can also select batches that are representative of the variation that can be expected from a specific product, and those batches can be tested by customers.

“This is the way that we … support a smooth transition from batch to continuous manufacturing—by addressing the challenge of raw material variability,” Fathollahi adds.

Fathollahi was featured as a speaker at AAPS PharmSci 360 where she gave her talk, “

Impact of Raw Materials Variation On Continuous Feeders Performance

.” Her presentation centered around gaining a better understanding of the natural batch-to-batch variability of raw materials; understanding the link between raw material variation and the manufacturing process; understanding which variation is present in a given raw material and what that specific variation means for the manufacturing process; assessing the risk of using raw materials (with their natural variation) on process robustness and consistency of the final product; and understanding how to derisk the use of excipients in continuous manufacturing processes.

redesign concepts for continuous manufacturing

Sara Fathollahi, PhD, product application specialist at DFE Pharma, makes the case of how excipient suppliers can support the transition from batch to continuous manufacturing.

A Look at How Excipient Suppliers Can Support Adoption of Continuous Manufacturing (AAPS PharmSci 360)

® at AAPS PharmSci 360, Sara Fathollahi, PhD, product application specialist, DFE Pharma, discusses one of the major challenges in the adoption of continuous manufacturing: variation in raw materials.

There is variation in raw materials, including both excipients and active pharmaceutical ingredients. Variations can include particle size, white density, etc., and these variations may impact the quality of the final product, Fathollahi states.

“This is very important to consider, and the manufacturers that want to enjoy the benefits of continuous manufacturing, such as faster production, more efficient production, and lower cost, [should] plan to overcome this challenge,” says Fathollahi.

Typically, manufacturers manage this challenge by, first of all, selecting a reliable raw material supplier to ensure consistent delivery of raw material with high quality. “[Manufacturers] work closely with excipient suppliers to understand the variation in their raw materials that they receive from them, and also, in line with what is designed for continuous manufacturing, they assist this variation in what it means for their process and what is the impact on the final product,” she says.

excipient suppliers supporting continuous manufacturing adoption

Sara Fathollahi, PhD, product application specialist at DFE Pharma, discusses a major challenge in the adoption of continuous manufacturing.

The Challenge of Raw Material Variation in Adopting Continuous Manufacturing (AAPS PharmSci 360)

® at AAPS PharmSci 360, Sara Fathollahi, PhD, product application specialist, DFE Pharma, points out certain redesign concepts that are critical for switching from batch manufacturing to continuous manufacturing.

One key critical concept involves quality by design (QbD), in which a systematic approach is used in pharmaceutical development that focuses on designing quality into the product from the beginning, she says. “It includes defining critical quality attributes, identifying critical material attributes, [and] critical process parameters using their risk assessment and experimentation to understand and control manufacturing processes,” Fathollahi emphasizes.

Fathollahi goes on to explain that one big benefit of the QbD approach is that it helps manufacturers to better understand the correlation between raw materials, the process, and the quality of the final drug product. “This is important, as it supports robust and consistent production in a continuous manufacturing environment,” she explains.

“Embracing quality by design supports manufacturers in designing processes [such] that they are able to compensate variation seen in raw materials without compromising on quality, stability, and functionality of the final drug product,” Fathollahi concludes.

Sara Fathollahi, PhD, product application specialist at DFE Pharma, points out important redesign concepts critical to adapting continuous manufacturing.

Redesign Concepts Critical for Continuous Manufacturing (AAPS PharmSci 360)

The American Association of Pharmaceutical Scientists (AAPS) announced results on Oct. 30, 2023 from its 2023 Salary Survey, which showed that salaries for those employed in the pharmaceutical sciences within the United States saw a compensation increase of 6.7% since 2022.

AAPS specified in a press release that the mean annual base salary earned by those employed full-time in the US as of June 1, 2023, was $190,100. Data from the US Bureau of Labor Statistics, in comparison, shows that compensation rose 4.5% across all industries from June 2022 to June 2023.

“It is refreshing to see that salaries continue to rise in pharmaceutical science despite a challenging year in the biotech sector,” said 2023 AAPS President Patrick J. Sinko, in the press release. “Pharmaceutical science is resilient in the face of layoffs, picked up M&A [merger and acquisition] activity, and reduced venture funding. While we are all facing this disruption, the industry still needs scientists to advance the capacity of pharmaceutical scientists to develop products and therapies that improve global health, which is also AAPS’ mission.”

According to the organization, the AAPS Salary Survey is the only survey that exclusively tracks compensation data within the pharmaceutical science sector. The organization surveys its membership each year about salary and compensation information and collects demographic data. The survey collects base salary information and supplemental income, including bonuses, summer-time work, grants, summer teaching, and others. The survey also collects information about income from other professional work, such as consulting, and salaries outside the US. The data are broken down by education level, years of experience, and career field (industry or academia).

A recent AAPS Salary Survey shows a rising trend in compensation for pharmaceutical scientists since 2022. 