Agenda

All times displayed for Europe/Madrid timezone.

Conference

Keynote Presentation I Introduction to Biopharmaceutical Processing and Manufacturing
10:30 - 11:00 bioLIVE Content Dome
Innovation in Bioprocessing & Manufacturing - Towards Continuous Manufacturing
President & Managing Partner
BioPlan Associates
Panel Discussion I Continuous Manufacturing
11:00 - 12:00 bioLIVE Content Dome
Innovation in Bioprocessing & Manufacturing - Towards Continuous Manufacturing
Owner|Professor BA Chemistry
Global Regulatory Affiars and Consulting | UB University Argentina
Industry Director
CMAC
President & Managing Partner
BioPlan Associates
Senior Scientific Advisor
The Center for Process Innovation

Towards Continuous Manufacturing – what are the challenges key industry players are facing when trying to establish continuous manufacturing processes in biologics? Join this panel to find out what role technology, equipment and regulations play in the implementation of continuous manufacturing processes.

Interview I A CDMO Perspective on the Trends and Innovations that Provide Speed and Flexibility in Biomanufacturing
12:00 - 12:30 bioLIVE Content Dome
Innovation in Bioprocessing & Manufacturing - Towards Continuous Manufacturing
President & Managing Partner
BioPlan Associates
VP, BUSINESS DEVELOPMENT
Catalent Biologics

As the biologics industry grows, biopharmaceutical companies are looking for ways to increase efficiency and speed to market for their biologic drugs. One area of focus is drug substance development and biomanufacturing. During this interview, Andrew Sandford, VP, Business Development - Biologics at Catalent Biologics, will discuss emerging trends and technologies and how they will impact biomanufacturing in the future

Lunch Break
12:30 - 13:30 bioLIVE Content Dome
Lunch Break
Presentation I Use of disposable technology in BioPharmaceutical manufacturing - Intensification of a Perfusion Platform using Single-use XCell™ ATF Systems
13:30 - 14:00 bioLIVE Content Dome
Innovation in Bioprocessing & Manufacturing - Single Use Systems
Senior Scientist
Patheon
Presentation I The Ongoing Revolution of Single Use Technology
14:00 - 14:30 bioLIVE Content Dome
Innovation in Bioprocessing & Manufacturing - Single Use Systems
Director of Project Development and Business Development
Mycenax Biotech
Presentation I Overcoming Protein Aggregation Challenges with Novel Tools for Protein Stabilization
14:30 - 15:00 bioLIVE Content Dome
Innovation in Bioprocessing & Manufacturing - Advances in Upstream and Downstream Processing
Technical Applications Specialist - BioPharma
Roquette
Presentation I bitop Binex – Simplifying bioprocessing to protect the environment, improve the product and reduce costs
15:00 - 15:30 bioLIVE Content Dome
Innovation in Bioprocessing & Manufacturing - Advances in Upstream and Downstream Processing
Chief Scientific Officer
Bitop AG
Presentation I Developing a common process and manufacturing multiple antibodies - challenges and solutions
15:30 - 16:00 bioLIVE Content Dome
Innovation in Bioprocessing & Manufacturing - Advances in Upstream and Downstream Processing
Head of Biologics Manufacturing
Syngene International

Sponsored by:

Presentation I Maximizing Process Value Using Modern Chromatography Media
16:00 - 16:30 bioLIVE Content Dome
Innovation in Bioprocessing & Manufacturing - Advances in Upstream and Downstream Processing
Manager Bioprocess Chromatography EMEA
Bio-Rad

bioLIVE Insight Briefing

The world’s first long-acting HIV fusion inhibitor
11:30 - 12:00 bioLIVE Insights Theatre
Insight Briefing
International Division
Frontier Biotechnology

Sponsored by:

Frontier Biotechnologies Inc., a leading science-driven biopharmaceutical company in China, received MA for Albuvirtide for injection (ABT), China's first new drug for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.  ABT is a new chemical entity (NCE) with novel molecular mechanism of action and long-acting activity against HIV-1. ABT is approved for use in treatment-experienced adults who still have virus replication, in combination with other antiretroviral agents.  ABT is the first new HIV medicine discovered and developed in China and the first long-acting HIV drug in the world. Data from interim analysis of phase 3 clinical trial showed that ABT was safe and effective against major strains of HIV including resistant viruses, and the efficacy was long-acting (once weekly dosing). Please visit our booth stand 12B11 for more details.

Purity Testing of Silicone Tubing for Biopharmaceutical Applications
12:00 - 12:30 bioLIVE Insights Theatre
Insight Briefing
Technical support and development, Biopharma Processing
Dow Medical Solutions

Silicone Tubing are widely used in biopharmaceutical processes for fluids transportation in various steps including final filling step where the highly valuable final drug product is in direct contact with the silicone tubing. In the final packaging step, contamination must be as minimal as per guidance, particularly as the drug product has already undergone sterilization. Consequently the biopharmaceutical industry is very cautious about the cleanliness of the silicone tubing. Subsequently much focus is given on tubing testing with regard to Particulates, Endotoxins and Bioburden. As a responsible supplier we have conducted the testing on our products. In this presentation, we are presenting the testing results on Dow Corning® Pharma Tubing range. The tests were performed per the USP <788> Particulate Matter in Injection, the USP <85> Bacterial Endotoxins Test, and the ISO 11737-1 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products.

The novel journey of mAb biosimilar innovations to success
12:30 - 13:00 bioLIVE Insights Theatre
Insight Briefing
Director
Prestige BioPharam

Sponsored by:

PRESTIGE BIOPHARMA PTE LTD is a company based in Singapore and Korea specializing in the discovery and development of the innovative antibody drugs. Based on the cutting-edge technologies and GMP manufacturing facilities, the company features multiple pipelines.
With Herceptin Biosimilar (HD201) and Avastin Biosimilar (HD204) which are in the midst of global clinical trials at the top, especially, the company has the leading position globally in the biosimilar market.
I would like to take this chance to introduce our company’s development and manufacturing capability.

MabPlex Capabilities
13:00 - 13:30 bioLIVE Insights Theatre
Insight Briefing
VP of Business Development and Marketing
MabPlex International

MabPlex provides world-class solutions to biopharmaceutical clients globally. Our company is based on the quality by design (QbD) principle, from site construction to manufacturing and delivery of our clients’ biologic drugs. With an expert team adept in both chemistry and biology, MabPlex provides global CDMO services in biopharmaceuticals. Capabilities span the scope from monoclonal antibodies (mAbs) and fusion proteins to the most complicated antibody–drug conjugates (ADCs). Our manufacturing space offers flexibility and complete services from upstream cell line development to manufacturing and fill–finish of commercial drug products. Our technical expertise allows us to provide effective high-quality solutions for your biomanufacturing needs.

ThioBridge™ Antibody Drug Conjugate Toolbox: A technology for enhanced conjugation and in vivo efficacy
13:30 - 14:00 bioLIVE Insights Theatre
Insight Briefing
Business Development Associate
Abzena

Sponsored by:

Life Science Solutions from HORIBA
14:00 - 14:30 bioLIVE Insights Theatre
Insight Briefing
Business Development Manager for Life Sciences
HORIBA

Sponsored by:

Proteins hold great promise for therapy, diagnosis and prevention of disease. However, their complex and unstable nature makes them challenging to control during handling and processing. In order to assist you in characterizing the many complex facets of biologics, HORIBA Scientific offers a wide range of off-line and on-line analytical tools that improve your decision-making skills to provide rugged control for cell-based manufacturing. During this presentation, you will learn more intimately about the innovative and unique tools we offer from the characterization of raw materials and classification of cell culture media, to real-time monitoring of multiple critical parameters and assessing particulate formation/stability to screening/quantifying proteins in complex matrices. The wealth of information provided by the combination of HORIBA’s molecular analysis technologies offer rugged control of complex processes, leading to safer therapeutics.

Competiveness of Large Scale Manufacturing
14:30 - 15:00 bioLIVE Insights Theatre
Insight Briefing
Business Development Lead
Samsung BioLogics

Sponsored by:

In the cost competitive environment of biopharmaceuticals, manufacturing costs are a key component to maintaining an edge in the market. Large-scale, stainless steel manufacturing, along with innovation in facility design provide cost advantages to biopharmaceutical companies. Furthermore, the increase in global biosimilar approvals and continued pressure from pricing policies further enhance the need for controlling manufacturing costs. Learn how manufacturing excellence, combined with state-of-the-art facilities and technology are advancing the biopharma industry. A live, guided tour of Samsung Biologics’ world-class facility via telepresence technology will make this a must-see event.

Biosimilar Development – Efficient by Integration of Experience
15:00 - 15:30 bioLIVE Insights Theatre
Insight Briefing
Chief Business Officer
The Biosimilars Group

Sponsored by:

• Accelerate development by integration and experience
• Best practice to establish QTPP
• Analytical similarity and comparability – the status quo
• CDMO experiences with a challenging biosimilar

Endotoxin purified gelatin for sensitive in body and regenerative medicine applications
15:30 - 16:00 bioLIVE Insights Theatre
Insight Briefing
Principal scientist and R&D project manager
Rousselot

Sponsored by:

Gelatin is a traditional and safe excipient extensively used in oral pharmaceutical applications. It is derived from collagen which is part of the natural extracellular matrix . Due to its low allergenic potential, suitable biological properties, and tunable physical characteristics, gelatin is an interesting material for (bio)medical applications.
However, since gelatin is sourced from natural raw material it might contain unwanted contaminants like endotoxins. Endotoxins are found in the outer membrane of gram-negative bacteria and under certain circumstances they can provoke profound negative reactions in the body such as strong immune responses and even sepsis. Underlying mechanisms are that endotoxins are able to bind specific receptors, namely toll-like receptors, which might trigger pro-inflammatory pathways. Hence, for medical in “body use” applications, like hemostatics, injectables and regenerative applications endotoxin level requirements are strictly defined i.e. <20EU/g (0.5EU/ml) for medical devices targeting blood and lymphatics applications and <2.15EU/g (0.06EU/ml) for cerebrospinal applications.
The presentation gives an overview of the current and potential uses of gelatin in (bio)medical applications and provides examples of the importance of using gelatins with low endotoxin levels.

Measuring pharmacokinetics of therapeutic antibodies in mice
16:00 - 16:30 bioLIVE Insights Theatre
Insight Briefing
Senior R&D scientist
Admescope
Senior R&D scientist
Admescope

Sponsored by:

We will present a method overview and results of our mouse PK-studies with Infliximab and Trastuzumab employing two different bioanalysis methods; LC-MS and ELISA.