Passwords are still the weakest link in a security system. Biometric access control systems would have prevented the recent data breaches at Sony and Gawker.There are a plethora of examples one can give of security breaches where a company didn't just incur millions of dollars in damage, they also lost the trust of their customers. Access control systems that still use the traditional password system are still in danger of security breaches that could happen at any time. Even in the face of such examples, companies still make simple mistakes like using weak passwords and not changing them often. According to some reports, more than 70% of security breaches are carried out with the help of an insider who exploits his or her access to service and administrative accounts even after they have left the company a long time ago.The recent security breaches at Sony and Gawker highlight the vulnerability of the password system. Phishing or key loggers can easily be used to steal the password, among various other methods that exist.Security experts say that an organization should have a more personalized and multilayered approach in order to make their valuable data more secure from cyber attacks. Furthermore, companies do not wish to cause any inconvenience to their users and employees and, therefore, do not take the steps necessary to ensure a more fool-proof security system. What is required is a security system that identifies a person instead of a code. This is where Biometric access control systems come into play, especially fingerprint access control systems.The use of such access control systems will guarantee that only the correct individual is identified and granted access to the system. Fingerprint access control systems save the unique fingerprint of a person in its database and grant access only to them. This is the most efficient manner in which the movement of people in a system can be monitored.A modern and technologically advanced fingerprint access control system is equipped with a scanner that captures a high resolution image of the fingerprint. These systems have gained acceptance in a number of places like banks, hospitals, etc. and are increasingly being used in place of password systems to mark attendance and grant access.
Stem Cell Clinical Trials and the Challenges The therapeutic stem cell and Advanced Therapeutic Medicinal Product (ATMP) market is continuing to develop. Over the last two years the focus of industry discussion groups within the UK has moved forward from research techniques during development to the challenges of GMP manufacturing these products. Once manufacturing issues are resolved focus will move onto the challenges of stem cell clinical trials. The difficulties of obtaining approval from authorities to conduct the trials will be the main focus of the sponsor. With these challenges ahead, there may be little time to focus on the actual method of labelling, storage and distribution of the product to the trial sites. Challenges of Stem Cell Clinical Trials Phase I trials are generally conducted at a single site with a single investigator and a close relationship between the investigator and the sponsor. The investigator in these trials is often a pioneer in their field and closely involved with the development of the product. Trials involving autologous products require collection of cells, processing of the cells and delivery back to the cell donor; this whole operation may be conducted on a single site or alternatively it may require transport to a separate site for cell processing and then return of the material to the same patient. Although the manipulation of the material and the technology to process the cells is extremely complex, the logistics of the trial are relatively simple. It requires secure traceability of the sample, obtained by following good manufacturing practice (GMP) guidelines and a validated shipper, which transports the material at the desired temperature between the patient and the processing site. Following production and labelling the material will require confirmation that it is GMP compliant; in the EU this is confirmed by a Qualified Person (QP). At Phase II the study is likely to take place at more than one investigator site. For autologous treatments this has the added complication of more than one patient's treatment being processed at the same time. Traceability of samples is critical and the synchronisation of patients, the manufacturing site and QP availability becomes more complex. Competent project management and good planning should overcome these difficulties. Additionally tracking systems for these samples using patient biometrics are being developed which would flag up an incorrect sample being returned to a patient. Allogeneic products are derived from stem cells which are used to treat people other than the donor. These cells are typically manufactured in batches, on a larger scale and may be intended for use in trials in a number of countries. Labelling Solutions One issue faced with clinical trials of ATMP products is ensuring regulatory compliant labelling. The primary containers must be labelled during the manufacture and prior to freezing. Consideration needs to be given to the labelling process of the primary containers ,once frozen to -80 or -196??C, the primary container cannot be labelled , therefore producing bulk unlabelled batches and then determining which trials the stock will be allocated to at a later date is not possible. Distribution Once the product is packed in primary containers (units), it may be shipped to a second site for secondary packaging, storage and distribution to clinical sites. This is similar to the logistics of more traditional pharmaceuticals. For example, bulk batches of labelled material could be shipped from the manufacturer to a storage site. These could then be assembled into kits in a cryostorage box, containing enough material to dose one patient. Alternatively, to avoid cell wastage material could be handled with a 'just in time' packing method, which has proved successful in more conventional drug trials where the drug is either very scarce or very expensive. Receipt at the investigational site would be simpler using the kit model, the site would not have to record receipt of each individual tube into inventory. In addition the secondary container could be tamper proof, giving added protection to the primary tubes. This can be particularly important if the cells are to be stored at the investigator site's own cryostorage facilities rather than in the nitrogen shipper, as cross contamination could be a risk. None of the issues in the clinical trial supply chain of stem cell products are impossible to overcome as long as there is consideration very early in the trial process for the method of labelling, distribution and on site storage of the product. Even for conventional products, it is a challenge to persuade sponsors to carefully consider the clinical supply chain at a sufficiently early stage. For stem cell products this is perhaps even more essential and it will be a continued challenge over the coming years for the supply chain companies capable of supporting ATMPs to engage with sponsors at an early enough stage to ensure the provision of a service that can meet patient recruitment needs and is affordable for the sponsors.
The techniques that are used in the dispersion of powders in both aqueous and non-aqueous media are quite similar. Dispersants aid wetting and stabilization of a suspension can be ionic (anionicor cationic) or non-ionic. However, concentrations of dispersants must be low. Otherwise, their properties are reduced or even inverted (i.e., cause aggregation or flocculation). In dispersing a powder in a non-aqueous medium, it is critical to select an organic solvent that is a good diluent as well as dispersant, although there are many organic dispersant aids. Aqueous surfactants are primarily responsible for reducing surface tension, hence aiding in the dispersion of powders in aqueous systems. The first task in dispersing a dry powder is the wetting of the sample with diluentor dispersant, if needed. Gentle spatulation of the resulting paste prior to addition of diluent further aids the dispersion process. Once the diluent is added, a sample of the slurry can be placed on a slide for a microscopic evaluation of the effectiveness of dispersion. Providing that the sample is well dispersed, the use of a magnetic stir bar is suggested to keep the sample fully dispersed, so are presentative sample can be drawn for analysis while stirring is in progress. Physical Methods of Liquid Dispersion Chemical Methods of Liquid Dispersion Wetting agents:Used to lower surface tension (e.g., hydrophobicity) between diluent (typically water) and particle (usually non-ionic agent). Surfactants: "Surface active agents" increase the surface charge of the particles in order to cause them to repel one another so that they remain properly dispersed while in the suspension.Types of surfactants include: Stabilization by Surface Charge Common Ions Multiple-charged Ions Surfactant Ions which charge the surface Reference -