Pharmaceutical Biotechnology: a look to the future
Biopharmaceutical products are nowadays a main pillar in the pharmaceutical industry, demanding significant transformations in the development, strategy, technology and operations.
Unlike conventional medicinal substances (so called “small molecules”), which are manufactured using chemical and physical techniques capable of a high degree of consistency, the manufacture of biopharmaceuticals involves biological processes. The starting materials are living cells (either prokaryotic or eukaryotic), which that must be frozen for storage, thawed without damage, and made to grow in a cultivation vessel. The expressed molecules must then be separated from the cells and the media in which they were cultivated, and purified without destroying their complex, fragile structures. These biological processes display indeed inherent variability, so that the range and nature of by-products may be variable. Reproducing these “large molecules” reliably at an industrial scale thus requires manufacturing capabilities of a previously unknown complexity and sophistication.
Entirely new concepts are those related to Advanced Therapy Medicinal Products (ATMPs), based on genes, cells, or engineered tissues. They are targeted therapies that deliver a therapeutic benefit to a patient-specific population, often treat rare diseases or improve upon existing therapies, and even offer more possibilities to regenerative medicine. Compared to other biomanufacturing processes, they present operational and technological peculiarities that must be supported by appropriate facility design.
Similarly, in GMP and Quality Assurance areas there are challenges, which need new and innovative approaches. The joined ISPE & PDA Italian chapters Workshop on Biotechnology on October 24th will address these topics and provide an updated overview of the current status of biotech manufacturing, allowing for a collaborative dialogue with representatives from primary biopharmaceutical manufacturers, the university, and international leading companies operating in the field of Life Sciences and providing solutions and engineering services for the biotechnological and pharmaceutical industry.
Agenda
08.30 Registration and welcome coffee
Morning session
09.00 - Welcome from ISPE Affiliata Italiana Teresa Minero - Chair
09.10 - Welcome from PDA Italia Angela Molaschi - Chair
09.20 - Lectio Inauguralis Prof. C. M. Joppolo - Politecnico Milano
09.50 - Biotech-a brief history S. Bonoli – Consultant
10.30 - Coffee Break
11.00 - cGMP Considerations for the design and operation of biopharmaceutical facilities: from therapeutic proteins to cell therapy.G. Bebber - Jacobs
11.30 - Facility layout structure for biotech manufacturing plants A. Bernardis - Wood
12.00 - Case study D. Lavallee - Merck Health Care
12.30 - Delivering the gene therapy promise: Progress and challenges in manufacturing viral vectors A. Boumlic - Merck Life Science
13.00 - Light Lunch
Afternoon session
14.00 - Sponsor Time
14.15 - Glycosaminoglycan based scaffolds for wound healing Prof. G. Sandri - Università di Pavia
14.45 - Cell therapy manufacturing – Living on the edge M. Valle - Anemocyte
15.15 - From Pharma to Biopharma: what is changing? A. M. Mora - BSP
15.45 - Coffee break
16.15 - New approaches for the process development of Antibody Drug Conjugates (ADCs) V. Sousa - Cerbios
16.45 - Q&A
17.00 - Closing