Preformulation and Formulation Development

Optimizing Conformational Stability and Biological ActivityMaintenance of the native three dimensional conformation is critical for the long term stability and biological activity of biotherapeutics. Biophysical characterization techniques such as circular dichroism, differential scanning calorimetry, FTIR, dynamic light scattering, and fluorescence spectroscopy provide a mechanism to assess the conformational and thermodynamic stability of proteins under a range of formulation conditions. These tools allow development scientists to differentiate various various buffer, pH, ionic strength, and excipient conditions, and identify the conditions that confer the optimum environment for the therapeutic protein.

Utilizing Advanced Statistical Design for Preformulation Development Preformulation development includes statistical design of experiments, allowing simultaneous evaluation of multiple factors and evaluation of interactions between factors. It is crucial to use advanced biophysical characterization techniques to evaluate the conformational stability of large molecules in addition to traditional methods for evaluation of chemical stability.

A large molecule preformulation development program typically includes the following activities:
Evaluate the effect of pH, buffer type, and ionic strength on solubility.
Evaluate the effect of various excipients on improving solubility if necessary.
Evaluate effects of pH, buffer type, and excipients on conformational stability.
Evaluate the effect of pH, buffers, excipients and ionic strength on physical and chemical stability.
Utilize a statistical design approach to identify the optimal conditions for structural, physical and chemical stability.
Perform forced degradation to elucidate product degradation pathways and to demonstrate the stability-indicating capacity of the analytical methods.
Forced degradation studies typically include restricted oxidation, deamidation, aggregation (via agitation), and / or acid / base hydrolysis.
Evaluation of heat stress, photo stress, and freeze thaw are also performed.

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Formulation Development for Numerous Dosage FormsFormulation development includes dosage forms for parenteral, oral topical and inhalation administration, including liquids, gels, suspensions, emulsions and lyophilized powders. Formulation scientists are highly skilled in the development of the dosage forms most relevant to biotherapeutics, with particular expertise in lyophilization and development of stable liquid formulations for proteins. High concentration antibody formulation development for subcutaneous administration requires particular emphasis on viscosity and tonicity. Lyophilization cycle development is performed in the context of the unique thermodynamic properties of the API to deliver an efficient, scalable, transferable process resulting in optimum product stability and reconfiguration characteristics. Formulation development capabilities also include:

Effect of excipients on solubility, tonicity, and viscosity Evaluation of antioxidant and conservative compatibility Container-closure compatibility Long term and accelerated stability studies.

Advantages of Formulation Development Approach. This outlined approach to preformulation and formulation development result in significant savings to the client by eliminating the variables associated with suboptimal formulations. Preclinical development efforts in PK, PD, ADME and toxicology occur with confidence that additional uncontrollable variables from unstable formulations are not introduced into the study. This benefit extends far into clinical trials as well, where assessment of toxicity, dosage levels and efficiency are substantially influenced by an optimal formulation that preserves the three dimensional conformation of the therapeutic protein. By eliminating uncontrolled stability variables, the focus is placed solely on the therapeutic performance and clinical outcome.

Simferopol, the Capital of Crimea – Simferopol City Guide

Simferopol is known as the capital and biggest city of Crimea. Every year millions of tourists go through this city to the Crimean resorts, such as Yalta, Sevastopol and Evpatoria. Today Crimea belongs to Ukraine and is its most southern region. After the collapse of the USSR in 1991, former Soviet Republics declared their independence, new countries emerged and Ukraine was one of them.

Simferopol is a pretty old, ancient city. Different civilizations occupied the area where the city is now situated over centuries. Finally, the city of Simferopol was founded by Russians in 1885. In old Greek Simferopol means a city of common good, or city-collector. The city was involved in many wars and battles during its long history. During the Second World War the Crimean region was tormented by the Nazi Germany. They took occupation of the city and used it as a strong base to withstand many attacks. Really, the history of this city is so rich! There is a number of historical attractions and artifacts which makes Simferopol a popular tourist destination for many tourists visiting it every year.

At present the total population of Simferopol is reported to be around four hundred thousand people. Administratively, the city is divided into 3 divisions. Due to its central location on the Crimean peninsula, it is a convenient place for many industries and facilities. Food and engineering industries are the two key ones that were developed in the city years ago, in the Soviet time. However more business is being established here today and the economics of the city keeps growing.

Simferopol has always been a cultural and educational center of the Crimea region. There are several Universities and many more colleges in the city. It is not surprising that Simferopol is called a student city sometimes. This city is also known with its famous theaters, such as the Crimean Academic Russian Drama Theater, Simferopol Puppet Theater and Crimean Ukrainian Music Theater. The city’s main public transport system consists of trolleys and buses that run throughout the city and connect the central area with suburbs. The Simferopol International Airport in the only one in Crimea. Different Ukrainian and international airlines have daily flights to Simferopol from Kiev, Moscow, Istanbul, and in summertime Simferopol is also connected with Germany, Israel, Armenia, Latvia, Uzbekistan and other countries. The majority of tourists get to Simferopol by train through. This transportation remains the most popular one in Ukraine due to affordable prices and a decent level of comfort the trains provide.

Since Simferopol is the capital of the Autonomous Republic of Crimea, the city is responsible for the administrative duties related to the special administrative status of Crimea within Ukraine. The Parliament of Crimea as well as the Cabinet of Ministers and other administrative institutions of the Crimean Republic are situated in Simferopol. Although Crimea has the status of a republic, the Crimean Parliament is subordinate to the Supreme Parliament of Ukraine which is situated in Kiev, the capital city of Ukraine.

Today Simferopol is a political, administrative, educational and cultural center of Crimea and of the whole Southern region of Ukraine as well as a popular tourist destination.

Fashion Jewelry – The Peridot Birthstone

Birthstones have gained its popularity in the 70s. Although it has waned in the 90s, it has made its comeback into the 21st century along with other jewelry and fashion accessories. Birthstones are not only fashion statements but personal statements as well. People love the idea of ​​wearing the stone designated to their birth month.

The Peridot birthstone is no exception. It is the birthstones of those people born on the month of August. It is a sparkling golden green in color and does not change in color. This gemstone is ideal for women born on August and who also happens to have clear green eyes. It brings out the green in their eyes. Because of its clear, sparkling green color, the Peridot is also very refreshing to look at. It has a calming effect as one gazes into the multi-dimensionally-cut Peridot green color. The Peridot gemstone is even called the "evening emerald" in some jewelry circles.

The Peridot has come a long way in history of fashion jewelry and fashion accessories. In ancient Egypt, the Peridots were often used along with other sterling materials as adornment for queens and pharaoh's headdresses. In the Medieval Period, the Peridot gemstone had been also used, along with some of the semi-precious and precious stones, to adorn, and beautify churches, and sacred church relics such as crucifixes, chalices used in mass, altars, etc.

The Peridot gemstone is ideal for fashion jewelry or fashion accessories such as necklaces, bracelets, earrings, and anklets. Peridots look best with gold, copper and bronze settings, giving it a rustic look. Most especially, Peridots are excellent with silver and white gold settings. This lighter pairing creates a dainty piece of fashion jewelry that can be used in day or night events.

As fashion jewelry and fashion accessories need not be expensive, this light green semi-precious stone can definitely serve the purpose of adornment for the August birthday celebrant without draining the pockets unnecessarily.

Local Internet Advertising Can Be Your Best Friend

Advertising online for a business is no longer the wave of the future. The future is now. Online exposures an industry to thousands of people with the click of a button. Most people will see a company's name on the web faster than anywhere in the advertising marketplace. Online has a variety of different advertising methods that one can utilize. There are national sites, as well as local sites. Free listings, paid ads, text, pictures, blogs, and pop ups are just a few methods. One can spend as much money or as little money, as they want to on promotional campaigns.

The type of business needing advertisements can help determine which sites to display. For example, when selling cars, a good placement is a website that sells auto parts or auto insurance. Any site connected to automobiles, including parts, service, or information is a good target site.

Public blog sites are an option that gets many hits. Place blogs about the company on public websites. There are local blog sites as well as national ones. Companies can also create their own blog page to boost content, links and visibility. A smaller business is well-suited to advertising online locally to reach the public sector they wish to reach. There is no need to advertise nationally without the business operates nationwide.

A key to advertising local online is to use search engine optimization (SEO). This is a method of taking the words a person may use in a search, and applying them to the advertisement text. The more search words used in the advertisement, the more people that will hit on the targeted site. If the desire is local advertising, add the preferred location so it will appear on a local search.

Utilize all the free listings, and place as many free ads as possible. The more times a business manages to place a listing, the higher it will rank. This ranking determinates in what order the site will come up compared to others when a search is launched.

Every company also needs a web page. Create one, even if it is only one page. The more colorful and graphic the page is, the more attention it will draw. Anytime a business places an ad, a picture should accompany the text if possible. Use photos that promote the business, but will also grab attention. It will not matter what the text says, unless the public is enticed to read it. Keyword research and careful selection of terms will help target potential clients. Learn to grab public attention, and the rest will follow.