2nd Edition
The Minipig in Biomedical Research
The second edition of The Minipig in Biomedical Research is a comprehensive resource for research scientists on the use of the minipig in basic and applied biomedical research. Written by experts in the field, coverage extends from the minipig’s origins, anatomy, genetics, immunology, pathology and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. The book represents the state of the art, recognising the growing influence of Artificial Intelligence, and where appropriate, relevant databases are referenced. The future of minipigs with respect to genome editing and possible use in transplantation research makes this a very interesting model.
Since the first edition was published there has been a considerable increase in scientific, industrial and regulatory interest in the minipig; in some jurisdictions, for instance the UK, it is mandated that the minipig should be considered as a first-line non-rodent model. The expert authors in this new edition have given practical details and extensive examples of its successful application in many fields including surgery, drug development and safety testing. Greater emphasis is given to the origins and uses of several different strains of minipig, the greater understanding of genomics, genetic manipulation, immunology, their value in the development of novel exploratory and therapeutic implantable devices, and genetic and surgical procedures.
The second edition includes full color throughout, with high-quality illustrations, making it the go-to guide and resource for present and potential new users of minipigs.
Chapter 0 – Introduction
Anthony Dayan, Andrew Makin, Kenneth Hastings, and Niels-Christian Ganderup
Chapter 1 – The Göttingen Minipig
Maja Ramløse, Susi Søgaard, and Kirsten Rosenmay Jacobsen
Chapter 2 – Sinclair Nanopig
Guy Bouchard, Derek Brocksmith, Yafei Chen, Wendell Davis, and Shayne Gad
Chapter 3 - The Yucatan minipig in research : A compendium
Alain Stricker-Kongrad, Derek Brocksmith, and Guy Bouchard
Chapter 4 - The Ossabaw miniature pig
Peter M. H. Heegaard, Yaolei Zhang, Mouhamad Alloosh, and Michael Sturek
Chapter 5 - The Bama minipig
Sue McPherson
Chapter 6 – Husbandry and Management
Roberta Scipioni Ball
Chapter 7 – Diseases of minipigs
Nanna Grand
Chapter 8 - Animal welfare standards around the world. AAALAC and beyond
Peter Clausing and Javier Guillén
Chapter 9 - Common surgical procedures for minipigs
Adrian Zeltner
Chapter 10 - Species selection for nonclinical programmes
Scott E Boley, Pallavi B. Limaye, and Guy Bouchard
Chapter 11 - Regulatory aspects of the use of minipigs in the development of pharmaceuticals for human use
Renqin Duan, Abigail Jacobs, Jan-Willem van der Laan, and Jianyong Wang
Chapter 12 - Regulatory Acceptance of the Minipig in Non-Pharmaceutical Industry and Research
Warren Harvey
Chapter 13 - The Minipig and Pig in Medical Device Research
Shayne Gad
Chapter 14 - Dermal toxicology in the minipig : skin architecture, metabolism, penetration and toxicological and pharmacological methods
William J. Brock, Drew Badger, and Andrew Makin
Chapter 15 - The Gastrointestinal Tract
Chris Van Ginneken
Chapter 16 - Central and Peripheral Nervous Systems
Alan Dahl Rasmussen Karen Malene Wegener
Chapter 17 - The kidney
Anthony D Dayan
Chapter 18 – Skeletal system
Hideki Tsutsumi
Chapter 19 - The minipig in regulatory guidelines for DART and juvenile toxicity studies
Edward Marsden and Sisse Ellemann-Laursen
Chapter 20 - The minipig eye as a model for preclinical toxicology
Mark Vézina, Ryan Boyd, and Martin Bussières
Chapter 21 - Oral Biology and Dental Models
Susan W. Herring, Lei Hu, Yiming Li, Zi-Jun (Zee) Liu, Tracy E. Popowics, Doris H. Rosero Salazar, and Songlin Wang
Chapter 22 - The use of the minipig as a suitable species for inhalation administration
Alice McNamara, Simon Moore, and Samuel Eniola
Chapter 23 - The Minipig in Safety Pharmacology
Andrea Greiter-Wilke and Stephane Milano
Chapter 24 - Spontaneous/background pathology of minipigs
Kris Helke
Chapter 25 - Immunological tools for minipig research
Peter M. H. Heegaard, Evelina Šťastná, Gitte Erbs, and Gregers Jungersen
Chapter 26 - Immunotoxicology
André H. Penninks and Kenneth L. Hastings
Chapter 27 - Osteoporosis Model in Minipigs
Hideki Tsutsumi, Satoshi Ikeda, and Toshitaka Nakamura
Chapter 28 - Use of minipigs in advanced therapy development
Pramila Singh and Keith Sutton
Chapter 29 - Xenotransplantation
Henk-Jan Schuurman, Melanie L. Graham, Thomas Spizzo, and Clive Patience
Chapter 30 - Digital biomarkers and AI
Szczepan Baran and Tomas Norton
Biography
Andrew Makin, BA, MSc, ERT, MRSB, is working as an independent toxicology consultant, having previously worked for nearly 40 years in contract research both in the UK and in Denmark. His experience covers a wide range of study types, involving many different species, and products from pharmaceuticals (large and small molecules), chemicals to medical devices and beyond. He has worked for more than 20 years with minipigs as a preclinical testing species and was one of the first appointees as Minipig Ambassador by Ellegaard Göttingen Minipigs.
Anthony D. Dayan, LLB, MD, FRCP, FRCPath, FBTS, retired as Professor of Toxicology at St Bartholomews Hospital Medical College, (now part of Queen Mary’s University) London. His previous posts included Head of Toxicology, Wellcome Foundation Research UK. He has been a member of regulatory and advisory committees for foods, pesticides and medicines, and for animal experimentation for WHO, EU, British and German governments, and he has consulted widely for biotech and pharmaceutical firms.
Kenneth L. Hastings, Dr.P.H., D.A.B.T., Fellow A.T.S. earned his Doctor of Public Health degree from the School of Public Health, University of North Carolina at Chapel Hill, in 1987. He completed his doctoral research at the Chemical Industry Institute of Toxicology. Dr. Hastings served as a US Peace Corps Volunteer in Fiji. He completed a post-doctoral fellowship in the Pharmacology/Toxicology Research Laboratory, Department of Anesthesiology, University of Arizona. From 1991 – 2007 Dr. Hastings served in the Center for Drug Evaluation and Research, US Food and Drug Administration, in various positions including as an Associate Director in the Office of New Drugs (2003 – 2007). Dr. Hastings was Associate Vice President for Regulatory Policy, Sanofi US. He served in many professional societies (President, Society of Toxicology Immunotoxicology Specialty Section; President, American College of Toxicology; President, SOT Regulatory and Safety Evaluation SS). Dr. Hastings served as President of the American Board of Toxicology. He is currently an independent consultant specializing in toxicology studies in drug development.
Niels-Christian Ganderup, MSc, MBA, is Snr. Business Development Manager at Copenhagen Capacity where he is engaged in attracting life science investments into the Medicon Valley region centered around Copenhagen. Prior to this he was in specialist clinical genetics testing company providing cutting edge genetic analysis for complex diseases in neurology and endocrinology. Before this he worked with engagement worldwide with academic, pharmaceutical, and other industrial research organizations and CROs in comparing the value of the minipig and other species in research and testing programs in pharmacology and toxicology. He founded the Minipig Research Forum which organizes annual scientific conferences in Europe about all aspects of the use of minipigs in biomedical research.
