Dr Joanna Sanford – CEO Sanford Biotech

Dr Joanna Sanford with her beloved Lola (French Bulldog) and Tola (Boston Terrier)

Dr Joanna Sanford with her beloved Lola (French Bulldog) and Tola (Boston Terrier)

Joanna Sanford is a biologist and biotech entrepreneur with international experience in cell biology, regenerative medicine and the development of medicinal products based on mesenchymal stromal cells (MSC).

 

She has worked in research and operations in Germany, the United States and Poland. Her experience covers both technology development and hands-on responsibility for the manufacture of biological products, quality control, GMP systems and compliance.

 

A distinctive feature of her professional profile is the combination of three competencies that matter most for a biotech company: science, controlled manufacturing and regulatory compliance. As CEO of Sanford Biotech, she now applies this experience to the development of MSC products, the SB-REG-KMAS programme and the build-out of the company's own manufacturing infrastructure.

Three key areas of expertise

Human MSC products

Experience in manufacturing and releasing batches of MSC-based medicinal products for humans, running a tissue and cell bank, and acting as Qualified Person.

Science, Manufacturing & Compliance

From research and bioprocess development to GMP, quality control, validation, Qualified Person and regulatory compliance.

From Science to Product

Joanna Sanford's career has developed at the interface between scientific research and its practical application.

 

In cell therapy, she has carried out and supervised cell isolation and expansion, cryopreservation, product formulation, quality control, batch documentation, the setting of release criteria, the manufacturing process and validation.

 

As a result, she evaluates the development of a biological product not only in terms of its scientific outcome, but also its reproducibility, scalability, safety and regulatory requirements.

Human MSC – experience with medicinal products for humans

One of the most important elements of Joanna Sanford's experience is hands-on work with MSC-based medicinal products intended for use in humans.

 

She headed a human tissue and cell bank working with material derived from sources including blood and adipose tissue. The bank held Polish registration PL010921 and the international ICCBBA identifier Z4224. Its activities also included the development of products using the stromal vascular fraction (SVF).

 

Joanna Sanford served in the formal role of Qualified Person (QP) under Polish pharmaceutical law and GMP requirements. She was responsible for assessing the compliance of manufacturing and quality control processes and for releasing batches of MSC-based medicinal products intended for human use.

 

This experience is directly relevant to Sanford Biotech's current work. It makes it possible to design product development with the requirements of later stages in mind: scale-up, manufacturing, quality control and preparation for the regulatory process.

Science, Quality & Compliance

Joanna Sanford's compliance experience goes well beyond knowledge of the regulations.

 

It includes practical responsibility for running laboratories, tissue and cell banks, quality systems and manufacturing processes. She has written, implemented and audited standard operating procedures (SOPs) and overseen documentation, traceability of biological material, critical processes and validation.

 

She also has many years of experience in clinical and preclinical studies, study monitoring, GLP and GMP. In the United States, she worked in an environment requiring compliance with FDA and USDA procedures, and on projects linked to the National Institutes of Health and the National Institute on Aging.

 

For Sanford Biotech, this means compliance can be built in at the product and process design stage, rather than only before clinical trials or registration.

BSL-3 and biosafety

Joanna Sanford also has experience managing teams and procedures in BSL-3 laboratories, which are designed for work with biological agents requiring an enhanced safety regime.

 

Working in such an environment requires specially trained staff, strict access control, rigorous procedures and consistent biological risk management.

International experience – Germany, USA, Poland

Joanna Sanford's professional experience was shaped in three different scientific and regulatory environments.

 

The point of this path was not simply working abroad, but later applying in Poland the standards of research, quality control, safety and project management typical of mature life science centres.

 

Germany – virology, immunology and oncology

Joanna Sanford was affiliated with the University of Würzburg. She worked at the Department of Neurology, then at the Institute of Virology and Immunobiology, where she completed her doctorate in virology, and later at the Rudolf Virchow Center for Experimental Biomedicine in the field of oncology.

Her research during this period focused on immunology, virology and cell biology, and laid the foundations for her later work in regenerative medicine.

 

United States – preclinical research, federal programmes and dual-use

Joanna Sanford worked at the Moffitt Cancer Center, and then at the Preclinical Research Center and the Obesity and Diabetes Research Center of the University of South Florida.

 

As a preclinical research project manager, she took part in the development and evaluation of new drugs and medical devices, including studies conducted in advanced animal models.

 

Her US experience also included long-term projects associated with the National Institute on Aging and dual-use biotechnology ventures carried out in an environment linked to US federal programmes and the defence sector. Due to the nature of some of this work, its detailed scope is not presented publicly.

 

Working in the United States reinforced an approach in which scientific quality is inseparable from process standardisation, safety, auditability and regulatory compliance.

Collaboration with Prof. Denis English

An important stage in the development of Joanna Sanford's experience in regenerative medicine was her collaboration with Prof. Denis English, a scientist affiliated with the University of South Florida College of Medicine and the Center of Excellence for Aging and Brain Repair.

 

His work covers research into the biological mechanisms of stem cell action and their use in tissue regeneration. He was also the founding editor of the journal Stem Cells and Development.

 

From 2008 to 2010, Joanna Sanford ran the Florida Foundation of Stem Cells Research and Development as owner and scientific consultant, working with Prof. English and clinical partners developing applications of cell therapies.

 

This stage of her career strengthened an approach that later became characteristic of Sanford Biotech: combining cell biology with product development and its practical application.

 

Poland – cell therapies and pioneering veterinary applications

After her time in Germany, dividing her activity between the United States and Poland, Joanna Sanford developed projects drawing on her earlier experience in cell therapies.

 

In 2010–2011, she worked at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, in the Cord Blood Bank, the Cell Therapy Laboratory and the Reproductive Tissue and Cell Bank.

 

From 2011, she developed Vetregen – a Stem Cell Laboratory and Bank for Animals. It was one of the pioneering projects in Poland applying regenerative medicine in veterinary practice. The venture received recognition including in the Innowator Mazowsza (Mazovia Innovator) competition.

 

In this way, her earlier experience with cell products for humans was combined with many years of veterinary practice, forming the basis of Sanford Biotech's current model.

 

Sanford Biotech – building a proprietary product platform

Sanford Biotech draws on Joanna Sanford's experience in science, cell therapies, biological product manufacturing and compliance to build its own platform of MSC-based products.

 

As CEO, Joanna Sanford is responsible for the company's technological direction, product development and the creation of its own manufacturing capabilities.

 

The aim is to create a platform that allows further products to be developed in a controlled, scalable and regulatory-compliant way.

 

SB-REG-KMAS – from research to a regulatory programme

SB-REG-KMAS is a candidate MSC-based biological medicinal product being developed for the treatment of mastitis – inflammation of the udder in dairy cattle.

Joanna Sanford's role covers oversight of the scientific work, the manufacturing process, the quality system and the regulatory environment of the project.

Regulatory compliance is an integral part of product development in the KMAS programme. Joanna leads and coordinates the work on the required environmental decisions and permits for the planned processing and manufacturing facility, and oversees the design work, infrastructure requirements and the development of operating procedures.

 

Our own GMP infrastructure

One of Sanford Biotech's key projects is building its own infrastructure for processing biological material and manufacturing cell products.

Joanna Sanford is directly involved in the design and oversees the construction of the processing and manufacturing facility being prepared to operate in line with GMP requirements.

 

The project includes cleanrooms, the organisation of material and personnel flows, cell banking and cryopreservation, quality control, materials management and the documentation system.

The strategic value of our own infrastructure lies in keeping key know-how within Sanford Biotech and creating a technology base for developing more than one MSC product.

 

Research and translational projects

Joanna Sanford was a consortium member in the STRATEGMED I project "Use of glial progenitors in the treatment of amyotrophic lateral sclerosis" (GRP & ALS), dedicated to developing advanced cell therapies for neurodegenerative diseases.

The results of this work were reflected in, among others, two publications in Scientific Reports, part of Nature Portfolio.

 

She currently focuses on developing allogeneic MSC products with immunomodulatory activity for animals, first in the SB-REG-KMAS programme, with the potential to use the platform for further indications and species.

 

Science and publications

Joanna Sanford is the author and co-author of publications in immunology, virology, cell biology, regenerative medicine and cell therapy. Her early work from the German period was published under the name Joanna Pfeuffer, and her later work as Joanna Sanford.

 

Joanna Sanford – ORCID 0000-0002-5158-2376

 

 

Selected publications

 

See other publications by the Sanford Biotech team

 

 

Ageing and regenerative medicine

Dr Joanna Sanford also works on the biology of ageing. She is interested in why the body becomes less able to repair its own tissues with age, and what role stem cells play in this. This is where regenerative medicine – the field that studies ways to repair damaged tissues – is looking for answers. Dogs live in the same environment as humans and develop similar age-related diseases. However, they live shorter lives, so the results of ageing research become visible in them sooner. This thinking is in line with the One Health approach – a shared view of human and animal health.

 

Talks and media

LinkedIn profile: Joanna Sanford