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.

The Beautiful Mountain Town of Sapa Vietnam

Sapa is one of the naturally serene and lush towns in Vietnam. It attracts many travelers with its magnificent landscape, which features colorful tribal villages, French colonial villages, lush vegetation and numerous green fields stacked on one after another.

Sapa is also close to Fansipan, the highest peak in Vietnam. Nestled at an elevation of 4921 feet or 1500 meters, Sapa is in Hoang Lien Son mountain range, in the northwest region of the country. Because of its geographical location, the town's rugged scenery usually experiences being clouded by a warm mist, which only adds to Sapa's beauty and charm, and making it truly a unique place to visit.

Sapa is about 376 kilometers from capital city of Hanoi. Sapa has risen to be the most popular mountainous district in Vietnam. You will easily be charmed by the terraced rice fields, the ethnic lifestyle and the cool climate, inviting you to stay longer in Sapa than you intended. Becoming a tourist destination paved the way for the establishment of hotels and accommodation facilities in this town so you do not have to worry about finding a place to sleep during those tranquil nights. If you really want to immerse yourself into the Sapa lifestyle, you can also arrange for a homestay in one of the tribal villages.

One of the best things to do in Sapa is walk around the town early in the morning as the tourist crow is not yet in full swing. The town is small, so you can easily navigate your way on foot. In fact, everything in and around town can be explored on foot making the most popular activity in Sapa – trekking. Trekking to various villages is fun and adventurous. Just make sure that you have good trekking shoes or boots and waterproof bag. There are also tours that involve renting a bike or motorbike to explore the countryside and visit waterfalls.

There are other less rigid things to do while in Sapa. You can always visit other neighboring villages like the Lao Chai Village, by hiring local transport like a jeep or van. You may also watch ethnic minor dance performances, sign up for the Hmong sewing classis and visit noticeable attractions like the Han Rong Resort, Sapa Culture Museum, the Sapa Lake, Bac Ha weekend market and the European orchid gardens and colonial buildings.

Sapa is home to a couple of ethnic minorities such as the Dazao and Hmong. These people live a simple life and have managed to maintain their culture and traditions. It is a rewarding travel experience to visit their villages and learn about their way of life. You can ask them to be your trekking guide instead of getting one through the hotel. Other than agriculture, the tribes are also now relying on tourism for a living.

Remember to always be respectful and courteous when dealing with them, especially when taking photos; always ask their permission first. The best time to visit the town is arguably from September to October as this is the period when the rice fields are turning their color from green to yellow. During wintertime, the town receives more of that appealing fog. No matter when you visit Sapa , you will definitely enjoy this new pin on your travel map!

Planning the Perfect Hawaiian Honeymoon

Whether you're getting married in Hawaii or just planning your honeymoon there, you definitely want to speak with some of the locals about the activities there. They will give you a different perspective about things to do and where to stay. You can also plan a wedding and honeymoon in Hawaii and have some of your wedding vendors help you with your honeymoon plans.

Because of the abundant splendor in Hawaii, your honeymoon will be filled with moonlit walks on the beach, drinks at sunset, and romance in the air. Few places can bring romance to your honeymoon the way that Hawaii can and you deserve it.

This is outside of the fact that Hawaii is native to many different kinds of tropical flowers, adding to the perfume of the air that comes so naturally. There is little to compare to the fragrance of tropical Hawaiian flowers in the air while snuggling with a loved one on the beach. Make sure you pick the right island for you Hawaiian honeymoon so you've always wanted. Do your research ahead of time and then talk with your local travel specialist so you can have the perfect honeymoon in Hawaii.

You can choose between any of the various vacationing spots in Hawaii, but it is often recommended to do one destination for a couple of days and then hop on over to another island to finish out your Hawaiian honeymoon.

Do not worry if you've been to Hawaii several times and you're not sure that you wan to honeymoon in Hawaii because it will not be special. All the circumstances have changed since you were there and it will be different with your new spouse in a tropical paradise. Plan on visiting several local sites, not just those for tourists, so you can experience Hawaii on honeymoon. Live like the locals for a few days and learn why so many people are attracted to Hawaii in the first place. Make sure your transportation is arranged ahead of time so you do not overspend on tour buses to take you places. Then you can explore the island on your own as well.

If you are thinking about the perfect Hawaiian honeymoon, keep thinking. There are so many things to choose from when it comes to planning a honeymoon of this sort, but there is nothing more romantic than a Hawaiian honeymoon. It screams tradition and is the perfect follow-up to a traditional American wedding.

My Master’s Degree – How Should I Talk And Write About It?

There are many circumstances in which foreign student have to talk about their intentions to study for advanced degrees. Statements of purpose written to accompany applications for university admission are the most obvious case, but the same situation comes up in interviews with recruiters, IELTS Speaking Tasks, and verbal interactions of all kinds with the officials at the universities you will be attending.

Unfortunately, it’s the time many foreign students say things that sound the least “English.” As a result, these unavoidable statements can often suggest that your command of English is weak. Even though all the native English speakers who regularly hear foreign students make these statements have long gotten used to hearing them spoken incorrectly, the mistake always registers with them at some level, however unconsciously.

To make the best impression on university administrators and IELTS examiners, use the right language to talk about your degree and your academic sentences.

The following are the most common mistakes:

“I’m going to learn a master’s degree.”

“I’m going to study a master’s degree.”

“I plan to learn a master degree.”

Don’t make these unnecessary but common mistakes. All that is necessary for you not to make them is to understand clearly what the appropriate words are and mean.

- A “master’s degree” is a noun. When written, it always has an apostrophe, that is, “master’s degree,” not “masters degree” or, worse, “master degree.”

- A master’s degree is not, however, a field of study. We don’t study a master’s degree, we study a field in which we earn (or, more colloquially, “get”) a maser’s degree. Therefore, in English, we say that we plan “to earn a master’s degree in marketing [or the name of some other field].”

- The degree is what we get as a result of studying, not what we study. So, when we talk about studying, we normally say, “I plan to study economics [or some other field].” It’s not incorrect to say, “I plan to learn marketing,” but “I plan to study marketing” is more normal, idiomatic English.

- The certificate that confirms that we have successfully completed a course of study and earned an advanced degree (not necessarily a master’s degree) is called a “diploma.” You can say, “I plan to earn a diploma in marketing,” or, if you have completed the degree, “I have a diploma in economics.” But if you do, realize that a native English speaker will not necessarily understand which graduate degree you have earned.

- The most appropriate verbs to use with “master’s degree,” prior to receiving the degree, are “study for,” “earn,” or “pursue.” So, you should say, “I plan to study for a master’s degree in communications,” or “I plan to earn a master’s degree in marketing,” or “I plan to pursue a master’s degree in engineering.”

This may seem like a minor matter in terms of language. However, making the most common mistakes can lead a university official or IELTS examiner to think less of your English language skills or, in the worst case, your intelligence.

So, practice writing and saying these simple but important sentences correctly.

Incorrect: I’m going to study a master degree.

Correct: I’m going to study for a master’s degree.

Incorrect: I will study a master’s degree of marketing.

Correct: I will study for a master’s degree in marketing.

Incorrect: I will learn a masters degree in economics.

Correct: I plan to earn a master’s degree in economics.