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.


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