Lyn left school without qualifications due to undiagnosed dyslexia, which was not identified during her school years. Her first job was as a dental nurse and during that time she completed her ‘O’ and ‘A’ levels on a part-time basis. Following what Lyn describes as a ‘light bulb’ moment, her enthusiasm for science began whilst watching a Christmas series of science lectures. Lyn studied for a degree in Applied Chemistry at the University of Huddersfield and began her career in science working as an analyst at Covance Laboratories (now LabCorp). Lyn went on to complete a PhD in ‘Chiral Resolution of Diastereomeric Salts using Supercritical Fluid Technology’ at the University of Bradford under the supervision of Professor Peter York, an Emeritus Professor of Physical Pharmaceutics and a world leading expert in pharmaceutical materials science.
Lyn joined Bradford Particle Design (BPD) in 1996, alongside company co-founder, Peter York, where the application of supercritical fluid (SCF) technology was first commercialised for pharmaceutical products. BPD was soon acquired by Inhale Therapeutic Systems Inc. (subsequently renamed Nektar Therapeutics) for US$200m. Lyn devoted a further 6 years working as a Research Leader at Nektar, continuing to pioneer the use of SCF in new product drug development, as well as working to create leadership opportunities for women in the sector. In 2006, Nektar took the decision to focus its resources on diabetes therapy and closed its SCF business. Lyn then took on a role as Technology Transfer Manager at the University of Leeds, where she played a key role in establishing a formulation network that led to the creation of Intelligent Formulation Limited.
In 2007, Crystec Limited (‘Crystec’) was established, with the aim of relaunching SCF for the pharmaceutical market, and specifically, its proprietary modified Supercritical Anti-Solvent (mSAS®) technology. Given her credentials, Lyn was quickly invited to return to the SCF fraternity and joined Crystec in 2008 on a part-time basis as Development Director, becoming full-time in the role in 2010. Since that time, Lyn has been responsible for the design and delivery of numerous scientific programmes for external client projects, as well as leading on proprietary molecules, compliance, new opportunity assessment, and development of intellectual property. Lyn has several publications, including various patent applications. Her SCF processing experience includes developing methods for controlling particle size and surface area, chiral separation, polymorph identification and control, generation of stable composite systems, and implementing novel processing approaches for engineering stable biotherapeutics.
Lyn has been a true pioneer of SCF technology, and mSAS® specifically, and a leader in its application for the pharmaceutical industry since the mid-1990’s. Throughout her career, she has led teams of all levels on the principles of SCF and its applicability to pharmaceutical science. As Development Director at Crystec, Lyn currently leads an operations team of five staff and has overseen the successful completion of many projects using mSAS® technology, ranging from engineering particles to meet the Target Product Profile (TPP) for inhaled delivery, to the identification of new polymorphs to support the creation of new Intellectual Property (IP). Notably, in 2010, Lyn worked closely with the UK Government on applying mSAS® to the successful stabilisation of biotherapeutics, demonstrating the viability of an inhaled Tissue Plasminogen Activator (tPA) formulation for treatment of COVID-19, maintaining 86.5% ± 10% activity.
As well as being an experienced and effective leader, Lyn also acts as a mentor to younger members of the Crystec scientific team, which includes two female graduates, as well as to members of the Business Development function. Her provenance as a woman working in SCF technology is unparalleled and she is therefore held in very high regard for her extensive knowledge and expertise within the organisation. Outside Crystec, Lyn has gained a following of over 6,000 professionals on LinkedIn, further testimony to her credentials in the field. Many enquiries received by Crystec are derived from Lyn’s extensive network of scientists within the industry.
mSAS® is a unique form of SCF technology. In her capacity as Development Director at Crystec, Lyn has successfully applied the technology to numerous projects. Whilst the technology was first applied to the processing of small molecules, over recent years, large (biomolecules) have become increasingly popular, now representing over 30% of new product approvals. It is acknowledged that biologics play a crucial role in treating complex disease, offering solutions where small molecules fall short. However, proteins are susceptible to denaturation from heat, agitation, freezing, pH changes, and exposure to interfaces, leading to inactive proteins, aggregates, and reduced clinical efficacy. Lyn has been instrumental in ensuring that mSAS® is equally applicable to the large molecule market, demonstrating her ability to think creatively and produce solutions to address new and complex challenges. Lyn has led a series of in-house innovation projects and the mSAS® process has been found to provide a superior alternative for generating dry, highly stable, free-flowing powders of biomolecules. Figure 2 illustrates the advantages of processing biomolecules in solid form using mSAS® compared to traditional methods.
The most advanced SCF-engineered therapeutic, Semprana® (formerly Levadex®) with Allergan, an inhaled treatment for migraine, successfully completed Phase III studies. Lyn contributed to the development of the process for this product; SCF particle engineering was the only technology able to generate particles of sufficient quality to repurpose the product from an injectable to an inhaled route of administration.
To further illustrate Lyn’s contribution to innovation, she has led and is named on the following patent applications:
1) Daintree, L. S., Kordikowski, A., & York, P. (2008). Separation processes for organic molecules using SCF Technologies. Advanced drug delivery reviews, 60(3), 351-372.
2) Daintree, L., & York P. Particle engineering to optimise the performance of inhaled medicines. Pharmaceutical Technology. 01.02.2014
3) Yin X., et al. (2015) Itraconazole solid dispersion prepared by supercritical fluid technique: preparation, in vitro characterisation, and bioavailability in beagle dogs. Drug Des Devel Ther. 28, 9: 2801-2810
4) US 10,413,519 B2 Crystal forms of tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride, processes of making such forms, and their pharmaceutical compositions
5) US 11759420 B2 Inhalable particles – tolterodine tartrate
6) United Kingdon Patent Application Number: GB231661.2 Tranexamic acid compositions
7) International PCT Application No. PCT / EP2024/072760. Crystalline compositions – Inhalis101 (SF2523)
Lyn is recognised as a highly professional member of the Crystec team, having consistently demonstrated an ability to work to the highest industry standards throughout her long career (e.g. principles of cGMP, GLP and MHRA/FDA requirements). Today, she supports junior members of the team with understanding various and often complex regulatory requirements associated with project execution. She is an active member of the Royal Society of Chemistry (RSC) and former RSC committee member of the Formulation Science and Technology Group.
Lyn is a strong advocate of the principles of Environmental, Social & Governance (ESG), and has demonstrated her commitment to having a diverse and inclusive workforce through her involvement in the recruitment process. As Crystec is a STEM (Science, Technology, Engineering and Mathematics) company, Lyn has an acute understanding that women and minorities tend to be underrepresented in the scientific world and has given speeches at schools in under privileged areas to encourage more students to take up careers in science. Lyn maintains an ongoing relationship with the University of Bradford to further support the STEM initiative and has run work experience programmes at Crystec to facilitate progression into chemistry.
Lyn’s 30-year career in the pharmaceutical industry has had a significant impact on the application of SCF technology as a viable and superior alternative for particle processing. Through her relenting passion, extensive knowledge, experience, and dedication, mSAS® has been successfully applied to address numerous development challenges, and perhaps most notably, in the advancement of Crystec’s in-house 505(b) assets for health conditions affecting women; CR002 for the treatment of urinary incontinence and CR003 for the treatment of post-partum haemorrhage.
Lyn as also been instrumental in the work carried out to demonstrate the applicability of mSAS® to biomolecules, leading the team at Crystec on internal projects to first demonstrate it as a viable technology and subsequently in successfully applying it to client-funded projects in relation to the development of monoclonal antibodies (mAbs), ribonucleic acid (RNA) and other large molecule therapeutics.
mSAS® is acknowledged to be a sustainable technology, utilising less energy and less solvent than more traditional technologies such as spray drying and micronisation. Lyn has always championed mSAS® green credentials whilst working tirelessly to continually reduce its environmental impact.
Lyn has managed and mentored young women and supported their development into managerial roles. At Crystec, she plays an active part in the recruitment process for operational staff.
In summary, Lyn has had long, illustrious and highly impactful career focused on the use of mSAS® to the industry. Recognition at the Making Pharmaceuticals Awards would be very well deserved indeed.
