Feliza Mirasol is the science editor for 

Feliza Mirasol

® 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.

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.

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

redesign concepts for continuous manufacturing

excipient suppliers supporting continuous manufacturing adoption

Articles

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. 

Salary Survey for Pharma Scientists Shows Increase of 6.7% Since 2022

At an AAPS PharmSci 360 press briefing on Oct. 24, 2023, Roquette announced the completion of its acquisition of Qualicaps, a manufacturer of hard capsules and pharmaceutical-related equipment, from the Mitsubishi Chemical Group. The acquisition represents a strategic investment by Roquette that is aimed at expanding the global footprint of its pharmaceutical business as well as enrich the company’s offerings of oral dosage solutions.

Through the acquisition, Roquette’s expertise in developing pharmaceutical excipients will be further enhanced by Qualicaps’ expertise in capsules and its assets and infrastructure. The newly combined business will offer diverse solutions with a full range of hard and soft capsules, fillers and binders, disintegrants, and other solutions, according to a company press release.

Qualicaps' global footprint is deemed an important asset for Roquette with manufacturing and R&D sites in Japan, Spain, Romania, Canada, the United States, and Brazil, which will allow Roquette to expand its global presence. The combined company will also provide technical capabilities through a single point of contact for the expanded offering, which Roquette expects will provide customers with improved of service and access to a stronger technical base for the development of future solutions and innovations.

“If we look at the talent, technique, and know-how of both companies, and we synergistically join them together, we can do better innovations, and we can serve our customers better. Qualicaps is strong in Japan as well as in Eastern Europe and North America, whereas Roquette is local. We are strong in Western Europe and in other countries in Asia outside of Japan, and we are making a presence in Eastern Europe,” said Rajeev D. Gokhale, global vice-president—Licensing Technology, Open Innovation and M&A, Roquette, in the press briefing.

AAPS PhamSci 360 runs Oct. 22–25, 2023 in Orlando, Fl.

The acquisition of Qualicaps reflects a strategic investment that aims to strengthen Roquette’s global standing in oral dosage solutions.

Roquette Announces Completion of Qualicaps Acquisition at AAPS PharmSci 360 

On Oct. 19, 2023, Waters Corporation announced that it has launched OligoWorks solid phase extraction (SPE) Kits and components, which are meant to improve sample preparation for liquid chromatography (LC)–mass spectrometry (MS)-based bioanalytical quantitation of therapeutic oligonucleotides.

The kits are designed to deliver up to 2x higher oligonucleotide recovery from biofluids, according to a company press release. The kits’ design also delivers improved LC­MS sensitivity and reproducibility for supporting robust quantitation. Because these capabilities enable lower limits of quantitation, the kits can reduce the need for repeat experiments.

The kits also use an innovative, enzyme-enhanced, and detergent-free sample pre-treatment that, according to Waters in the press release, reduces washing steps and improves mass spectrometer compatibility. This design enables for direct injection LC–MS analysis and is also what allows for the lower limits of quantitation. The kits can also be fully automated, which can improve productivity or simply help scientists gain back time via the reduction of manual steps and oversight.

The OligoWorks SPE Kits are available immediately and complement other Waters tools, including MaxPeak Premier Columns, ACQUITY Premier LC System and Arc Premier LC System, Andrew+ Pipetting Robot. The new kits also support the sensitivity of the Waters Xevo TQ Absolute Mass Spectrometer.

" … Waters is committed to solving customer pain points and enabling greater analytical performance and productivity. Our new OligoWorks SPE Kits directly address oligonucleotide bioanalysis sample prep challenges across diverse oligo therapeutics," said Erin Chambers, vice-president, Consumables and Lab Automation, Waters Corporation. "The science and societal effects of these therapies are exploding given their ability to address human health issues. Our workflow and kits will drive an acceleration of oligo bioanalysis projects and drug development timelines; ultimately improving the experience for drug candidates."

Waters has launched OligoWorks SPE Workflow and Kits, which is aimed at accelerating the bioanalysis of oligonucleotides.

Waters Launches New Oligonucleotide Bioanalysis Kits

The trend toward digital transformation in biopharmaceutical manufacturing continues as advanced technologies enter the scene and work their way through to manufacturing operations. With the availability of technologies to take automated biomanufacturing from preclinical to commercial-scale, the industry may start to see a wave of changeovers from manual processes to an automated, digital environment. This episode of the 

Podcast will discuss the realities of switching over from manual to digital, and what to expect.

Ajit Yeole, senior director, Life Sciences Manufacturing, Cognizant

Ajit Yeole is the senior director for Life Sciences Manufacturing at Cognizant, based in London, UK.He is responsible for strategy, smart manufacturing, developing new service offerings, and digital accelerators targeted towards addressing the industry needs. Has been closely working on engagements around manufacturing and quality involving emerging technologies (Industrial IoT, advanced analytics, AR/VR , and others) using agile and design-thinking-led approaches. He has led the manufacturing operations management practice for Cognizant in Europe and has delivered large manufacturing programs while collaboratively building tools and templates for consulting offerings. Previously, he worked in manufacturing operations management, IoT (M2M) and OT/ industrial automation as a consultant, solutions architect, and business unit head.

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte

Laks Pernenkil, PhD, is a principal in Deloitte’s Life Sciences Product, Supply, Manufacturing and Quality Operations practice based in McLean, Va. He has more than 15 years of consulting and technical operations experience in pharmaceutical, biologics and medical device sectors. At Deloitte, his experience includes smart/digital manufacturing and plant floor operations, plant engineering, facilities management, material sourcing, distribution, performance improvement, operational excellence, and market entry operations strategy.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode of the Drug Solutions Podcast, industry experts discuss the challenges and advantages of the digitalization trend in the biopharma industry, with particular emphasis on the impacts to biomanufacturing.