Biography:

Insang Lee was born in May 13, 1950 and raised in Seoul, Korea and B.S. at college of art of Chungang University in Korea. After that went to USA for sturdy more, B.S. at University of Colorado and MBA at University of Colorado.

He worked at State Metal Corp. as Sales Director of non-ferrous metal in USA and Sales Rep. of Kobe Steel of Japan in USA. He set up the factory in Korea for metal working such as brass bed, lighting fixtures and CEO of Tricomex International Corp in California for International trading corp. He set up the lab in Korea for Hydronium sturdy and test since 1998 to present.

 

Abstract:

Water has been considered as matrix of the world and of all its creatures. Some unusual and significant properties are involved in water such as its physical properties, chemical properties, solvent potency, hydrogen bonds forming ability and amphoteric natures. Biologists proved that water is the backdrop on which life’s molecular components are designed. The same applies to our finding that hydronium ions (H3O⁺) seem to have a better option for the water surface. H3O⁺ may form three donor hydrogen bonds to neighboring water molecules, but because most of the positive charge resides on the oxygen atom, it can no longer act as a good hydrogen bond acceptor. Indeed, this makes the oxygen somewhat hydrophobic, so that H3O⁺ acts as an amphiphile. In this way, reduced hydrogen bond capacity encourages the surface accumulation of H3O⁺, oriented with the oxygen atom outermost. As much the same behavior might be expected at hydrophobic surfaces, this finding could have significant implications for biomolecular hydration that have investigated by us; for example, one might expect to see a shift in the dissociation of protonatable residues close to hydrophobic patches and perhaps even a stabilization of hydrophobic species by a kind of surfactant behavior of H3O⁺. The water molecules solvating a hydronium (H3O⁺) ion can actually facilitate proton transport by shuttling it to another molecule. In this way, a specific proton does not itself diffuse through the medium; rather, there is a cooperative transfer of protons between successive molecules.

 

Biography:

Kunihiko FURUZAWA is charging in GMP consultant and publishing GMP article after over 30 years charging in development and quality mater under global regulation in Pharmaceutical organizations. He is focusing Quality system of manufacturing and quality assurance as risk based. Based on around 200 GMP audit/site investigations, he is good at to find visible/potential risk in site and to give the solution/CAPA hint.

 

Abstract:

Technical Transfer of processes to an alternative site occurs at some stage in the life-cycle of most drug substance/products, from development, scale-up, manufacturing, production and launch, to the post-approval phase.

Technical transfer is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites” as one part of Change control. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development, and or commercialization to an appropriate, responsible and authorized party.

Technology transfer embodies both the transfer of documentation and the demonstrated ability/capability of the receiving party(ies) to effectively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies.

Technical Transfer requires a documented, planned approach using trained and knowledgeable personnel working within a quality system, with documentation of data including of risk assessment/ mitigation covering all aspects of development, production, quality assurance and quality control.

For the transfer to be successful, the following general principles and requirements should be met:

1) the project plan should be based upon the principles of quality risk management, 2) the capabilities of the providing and at the receiving party should be similar, 3) a comprehensive technical gap analysis, technical risk assessment and potential regulatory gaps, should be performed as needed, 4) adequately trained staff, 5) effective process and product knowledge transfer.