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