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The future of women’s health is in collaboration

By Jessica Aird, manufacturing manager at Abingdon Health

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Jessica Aird, manufacturing manager at Abingdon Health

Abingdon’s Health’s manufacturing manager, Jessica Aird, takes a look at all things women’s health with a particular focus on how the organisation in which she operates so effectively – an expert lateral flow CRO & CDMO business –  works together to deliver innovation and change in this area on a daily basis.

On March 8, 2021, the government launched a call for evidence to inform the development of England’s first Women’s Health Strategy, with two main aims:

  1. First, to improve the way in which the health and care system listens to women, and to reset our approach to women’s health by placing women’s voices at the centre of this work.
  2. Second, to improve women’s health outcomes.

As part of this launch, the government called for organisations with expertise in women’s health to submit written evidence into the following:

  • Current medicines and medical devices.
  • Geographical differences in women’s life expectancy and access to services.

Women’s specific health can be categorised in two main stems of health needs: general and reproductive specific. The diagram below explores these two stems and how these needs change during the course of a woman’s life.

Two main stems of women’s health needs (Department of Health and Social Care, 2021)

Abingdon Health’s vision is to become the leading rapid test business globally and share our mission – to improve life by making rapid testing accessible to all – with all industries. This includes improvement to current women’s health testing solutions through the development and manufacture of new, innovative, and creative medical devices.

The role of Abingdon Health in the improvement of women’s health strategy does not just lie within the manufacturing process.

There are many supporting departments working in unison to ensure any devices which successfully enter the market are the best solution available for women to further improve their knowledge and understanding of their health and wellbeing.

R&D

Abingdon’s R&D team are either approached by commercial on behalf of a customer with a bespoke women’s health testing solution, or the idea comes from within the organisation.

The process of progressing the idea from a concept to small scale manufacture relies heavily on R&D. The team must develop the device with key focuses on:

  • Selecting the most efficient and appreciate materials
  • Testing for cross-reactivity
  • Optimisation and repeatability of performance
  • Scalability considerations are also considered at this stage.
Technical transfer

The key role of the technical transfer department is to take each R&D-proven small-scale manufacturable assay to a full-scale production batch; this could be up to 30,000 devices per batch run. This is achieved through the following processes:

  • Understanding potential failure modes, risk to assay performance and what current controls are in place in order to mitigate the risks. This is done predominantly by the technical transfer team, but also reviewed and adjusted collaboratively through input of many departments, including production, quality control, quality assurance and technical specialists.
  • Transferring the processes from small scale equipment to large production equipment within the production laboratories whilst understanding the how the process parameters must change to keep product performance optimised and results, sensitivity and specificity within range at scale.
  • Robustness testing of assay capacity and the assay performance in terms of scaling up the batches. This is done in order to understand the limitations of an assay. Robustness testing typically includes studies of treated materials, stability on part-processed components and stacked tolerances to determine optimal performance going forward.
Regulatory

Product regulatory compliance plays a significant role in bringing the concept of a new product in women’s health to reality and onto the market as fully reproducible manufactured product.

The regulatory team are part of development of the new assay from the very beginning; this is crucial as it helps the team to understand the regulatory requirements and anticipate where potential Quality Assurance and Regulatory Affairs (QARA) issues may arise.

The implications of a non-conformance at any stage of product development can cause significant timing delays, product redesign requirements and increased costs, so it is essential for QARA functions to have input at all stages of development of a new product.

Regulatory approvals are the last step before product launch to market. Obtaining official approval for a product to go to market, particularly in the case of a medical device, requires immense planning with manufacturing, quality assurance and commercial to ensure the product to be launched is viable and has the best chance of success in its newly obtained distribution regions and channels.

Customer services and commercial

Keeping the customer intimately involved in the product development process is essential to successful project and product performance and launch onto market.

The commercial team and customer services functions work hand in hand with both the new product development internal project team members and customer stakeholders to ensure direct interaction between both parties is maintained and expectations are managed.

Ensuring customers sign off at project stage gates, review quality control data and approve operating procedures and product process parameters all require commercial and customer service organisation.

Production and shipping

Once the product is ready for launch, customer service work closely with our quality, regulatory and warehousing teams to ship products to customer on time and in full. This can involve booking shipments with couriers, completing the product release process, and managing customer expectations of timelines.

In summary, the future of women’s health is indeed in collaboration: working closely cross-departmentally to take a concept or idea through to developing a product ready for marketing which can improve women’s access to healthcare, all the way through the research and development to technical transfer and production, is critical to success.

Working collaboratively will ensure better access to healthcare for women and inspire others to come forward with innovative solutions to everyday issues in women’s healthcare today and throughout the course of our lives.

To find out more, visit abingdonhealth.com.

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New pregnancy treatment shows promise for at-risk twins

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A high-powered ultrasound treatment could help identical twins affected by a rare and serious condition during early pregnancy, an initial study suggests.

Twin-to-twin transfusion syndrome, or TTTS, causes uneven blood flow between identical twins who share a placenta.

The imbalance can leave one baby dangerously small and the other too large, putting both babies’ survival at risk.

 

Brioney Garrett’s daughters were in danger before doctors used the world-first treatment to seal the blood vessels causing the problem without an operation.

Nancy and Margo were born healthy and, now aged four, are due to start school.

Researchers from Queen Charlotte’s and Chelsea Hospital tested the non-invasive procedure in 10 women from the UK and elsewhere in Europe after scans detected TTTS during early pregnancy.

Five women needed further treatment, while 12 of the 20 babies survived following the procedure.

The researchers described having a treatment that did not require a needle or telescope to be inserted into the mother’s abdomen as “extremely exciting”.

However, they said larger studies involving more pregnant women were needed before the procedure could be offered more widely.

Garrett described her daughters as “my miracle twins”.

She said: “We were in a very dire situation and I don’t forget that.

“It stays with me always how things could have been. Every day I still count my blessings.”

TTTS affects between 10 and 15 per cent of identical twins who share a placenta, representing around 300 to 400 pregnancies in the UK each year.

The uneven blood flow causes excess fluid to build up around the larger recipient baby, while leaving dangerously little fluid around the smaller donor baby.

Treatment usually involves inserting a needle into the womb to drain some of the fluid or using a laser to seal the connecting blood vessels.

Garrett’s procedure took about 20 minutes. She lay flat while a specially designed machine directed high-powered ultrasound waves at small blood vessels in her placenta.

She said: “It was very quick and pretty painless.”

Christoph Lees, head of fetal medicine at Imperial College Healthcare NHS Trust and professor of obstetrics at Imperial College London, described the research as “very promising”.

He said: “If this could work in a fully-fledged study, it could give hope to a lot of women who otherwise might have to have quite invasive treatment.”

Ultrasound is commonly used during medical scans to produce images of the body, but this procedure uses much more focused waves.

Heat generated by the waves can seal blood vessels about 2mm in diameter and located around 5cm to 6cm beneath the skin.

The procedure blocked blood flow in 90 per cent of the vessels treated during the study, with no unwanted side-effects reported.

Twins Trust, which supported the study, said the approach could make a significant difference for families affected by TTTS.

Helen Peck, head of healthcare engagement and research, said: “Any procedure that is non-invasive and can potentially identify TTTS earlier and improve outcomes for our families with this life-threatening condition could be a turning point.”

Scans carried out weeks after Garrett’s procedure showed that blood flow between the babies had been rebalanced, although other problems developed during the pregnancy.

Garrett said Margo, who had too little fluid around her, “was in a much better position” and that “the strain on Nancy’s heart had eased”.

Nancy and Margo were born at nearly 34 weeks, weighing 3lb 7oz and 3lb 3oz respectively.

Garrett said: “They were both healthy, and Margo wasn’t as small as we worried she was going to be.”

The twins are due to start primary school in September.

Garrett said: “They’re funny, smart, energetic little girls that just fit right in with their age group.”

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Breast cancer rising rapidly in Asian American women, study finds

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Breast cancer rates have risen rapidly among Asian American women over the past two decades, with some of the steepest increases among women under 50, new research has revealed.

Rates rose by more than three per cent a year in nearly every Asian American ethnic group studied, much faster than in any other US ethnic group.

The increase was particularly marked among women under 50 and in cases involving advanced-stage disease or certain aggressive subtypes of the cancer.

The study found even larger increases among Chinese and Vietnamese women.

Breast cancer rates among Native Hawaiian women were already among the highest recorded among US women, but rose by about one per cent a year, less than the increases seen in Asian American groups.

The researchers said increased screening was unlikely to explain the trend because screening would be expected to identify more cancers at an earlier stage.

Instead, cancers that had already spread increased at the fastest rate.

Triple-negative breast cancer, considered the most aggressive subtype, rose by more than six per cent a year among Chinese American women between 2017 and 2022.

Scarlett Lin Gomez, senior author and professor of epidemiology and biostatistics at the University of California, San Francisco, said: “These patterns are highly concerning from a disparities standpoint.

“They underscore why it is so important to move beyond treating Asian Americans, Native Hawaiians, and Pacific Islanders as a single population.”

Researchers analysed about 150,000 cases of invasive breast cancer diagnosed between 2000 and 2022 using data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Programme.

The analysis covered nine Asian American, Native Hawaiian and Pacific Islander populations across 14 states. Together, these states account for about two-thirds of the US population within these groups.

Except for Native Hawaiian women, Asian American women have historically had lower breast cancer rates than non-Hispanic white women.

However, the gap has narrowed rapidly. By 2022, incidence among Asian American women under 50 was comparable with that recorded among white women.

The reasons for the increase among women under 50 remain unclear.

Changes in reproductive patterns, diet and other lifestyle factors may play a part, but researchers said they did not fully explain the findings.

They said previously unidentified risk factors may also be contributing to the rises in some Asian American communities.

Researchers hope two UCSF-based studies, the CRANE breast cancer study and the ASPIRE cohort study, will provide insights into these factors.

Gomez said: “Understanding why breast cancer is increasing so rapidly in these communities is critical.

“At the same time, we need to ensure that women across all Asian American, Native Hawaiian, and Pacific Islander communities have access to culturally appropriate education, screening, and timely follow-up care.”

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Softening ovaries could extend fertility as women age, study suggests

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Softening ageing ovaries could help women remain fertile for longer, early animal research suggests.

Fertility declines with age for several reasons, including poorer egg quality, fewer ovarian follicles and the gradual stiffening of ovarian tissue.

Existing fertility treatments, including hormone therapy and in vitro fertilisation, mainly address hormonal imbalances or help eggs mature or become fertilised.

Scientists are now examining whether changing the physical structure of the ovaries could provide another route for future fertility treatments.

Stuart A. Cook, of the Cardiovascular and Metabolic Disorders Programme at Duke-National University of Singapore Medical School, published an accompanying commentary on the research.

Researchers led by Shixuan Wang at Huazhong University of Science and Technology in Wuhan, China, collected healthy ovarian tissue from younger, middle-aged and older women.

They also examined samples from patients with polycystic ovary syndrome, known as PCOS, premature ovarian insufficiency, or POI, and endometriosis.

PCOS is a hormonal condition that can disrupt ovulation. POI occurs when the ovaries stop working normally before the age of 40, while endometriosis causes tissue similar to the womb lining to grow elsewhere in the body.

Tests of protein levels and gene activity found higher levels of the inflammatory protein interleukin-11, or IL-11, in ageing and diseased ovaries.

In laboratory experiments, the researchers exposed ovarian fibroblasts to IL-11. Fibroblasts are cells that produce connective tissue.

The protein caused the cells to produce excess collagen, a structural material that can build up during scarring and make tissue stiffer.

The researchers then genetically modified mice so they could not respond to IL-11. The animals developed less ovarian stiffening and maintained better ovarian function as they aged.

Similar results were seen in mouse models of PCOS and POI caused by chemotherapy.

In the final part of the experiment, older mice and rats were injected with a nanoparticle treatment containing small interfering RNA, or siRNA, designed to switch off IL-11.

The treatment made the animals’ ovaries less stiff and improved fertility.

Pregnancy rates among older mice rose from 25 per cent to 50 per cent, while average litter sizes also increased.

More rats treated with the therapy became pregnant and produced larger litters.

The approach remains highly speculative and will require considerably more research before its safety or effectiveness in women can be established.

However, the researchers said blocking the inflammatory pathway could eventually form the basis of new fertility treatments.

They said: “We propose that anti-IL-11 therapy represents a promising translational strategy for delaying ovarian ageing.”

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