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.

How to Become a Millionaire – Here’s 3 Ways

It’s something that we all dream about and chances are if you had one wish you’d ask to be a millionaire right? But how can you become a millionaire is there some special knack or insider secret or is it just down to luck?

As I see it there are only really three ways to become a millionaire the first is to win the lottery now if you’re a person that likes to gamble this may seem a perfectly logical way for you to make a million the only flaw in your plan are the odds of winning, they are impossibly stacked against you. You stand more chance of marrying into money than actually winning it.

The Second way you can become a millionaire is to steal it. Conning or robbing people is not a very honourable way to build a fortune not to mention the dangers involved with criminal activities, not least the threat of spending time behind bars and losing all your ill gotten gains. Like disgraced businessman Bernard Madoff who pleaded guilty to the largest investment fraud ever committed estimated at 65Billion Dollars.

The Third way you can get wealthy is probably the hardest but ultimately the most ethical and most satisfying, it can be broken down into two separate fields so want to know how to become a millionaire? Yes well here goes…

In this world ordinary people are not rewarded for their skills. However, if you are extraordinary or have a rare highly sought after skill, you can be paid very very well think of top sportsmen or actors both have sensational but rare talents, not everyone can do what they do right?

The other way is to become an entrepreneur, forget about working for someone else you will never become a millionaire while working for a boss. The time to make it as an entrepreneur is now and the best way to be successful is to help people by solving their problems. If you can provide services or information that can solve people’s problems whether they be emotional, physical, or financial you can make money.

Think of The Hilton’s they solve problems by providing luxury accommodation for holidaying people. Or British Airways solving the problem of faster transatlantic travel, or even Bill Gates who solved computer compatibility problems with his now legendary windows operating system just think where we would be now without it, would you be even reading this?

So there you have it the real secret to being a millionaire is to be extraordinary and try to solve people’s problems and with the power of the Internet you can do this now easier than ever I hope you have enjoyed this article and you know have a better idea of how to become a millionaire.

Introduction to Teaching English in Japan

Would you like the chance to spend some time in Japan but feel turned off by whistle-stop package tourist trips? If so, teaching English may be the answer. There is no better way to get to know a country than by living and working there. By teaching English you become a part of Japanese society, rather than just an observer looking in.

Teaching English is big business in Japan. Despite the collapse of the so-called bubble economy Japan remains one of the richest and most sophisticated nations on the planet, and this status is largely due to its success in overseas trade and investment. Thus, to get ahead in Japanese society, proficiency in English is a significant advantage. Add to that the fact that being able to speak English is simply considered cool and the huge demand for English teachers becomes clear.

Don’t Japanese people learn English at school?

Yes they do. Usually for 6 years or more. The problem is that, unlike most of the school curriculum, English isn’t taught particularly well. Japanese schools tend to follow traditional teaching methods in which the teacher stands at the front and lectures the class. Students are expected to absorb rather than question. The method produces excellent results for subjects like history and mathematics, but not for communicative, participative skills like language. School English education is likely to consist of lots of reading and writing, lots of grammar practice, but very little – if any – spoken communication.

Do I need to speak Japanese?

Not at all. Of course, if you can pick up a little nihongo (Japanese) it will make your daily life easier, but it won’t help one bit as a teacher. The reason is that the most effective way of teaching language is to use only the target language. Thus the only language used in English lessons is English.

How do I start?

Well, you could simply buy a ticket to Japan and start looking for work. Unfortunately, without a work permit, that strategy is illegal. Unless you have a Japanese spouse you need to find a job that will sponsor you for a visa. It is possible to travel to Japan as a tourist and approach a few of the numerous schools advertising for teachers asking if they are prepared to sponsor your visa application.

It helps to undergo some TEFL (Teaching English as a Foreign Language) training before looking for work. Not only will this give you some basic teaching skills and confidence, but it also shows potential employers you are serious about teaching and not just a backpacker looking for some financial re-fuelling.

TEFL courses are advertised in most English speaking countries. The more useful ones are provided by working English schools and offer face-to-face teaching practice with real learners.

Accommodation

If you are employed by the JET program or one of the big English school companies they will more than likely arrange accommodation for you. You are of course free to find your own housing if you so wish.

Living in school-found accommodation has the advantage of an English speaking contact to sort out repairs or other problems. The disadvantage is that it’s difficult to quit a job that may not be for you while living in their accommodation. I have also heard of at least one school that charges its teachers a significant premium over market rental rates for use of its accommodation – so beware!

There are several English speaking accommodation agencies advertising in the free English language press, and these generally provide decent accommodation, but at a price.

An alternative favored by many single English teachers are the so-called “gaijin houses” (literally foreigner’s house). These are basically hostels that rent out basic, but adequately comfortable, rooms mainly to non-Japanese clientele. Usually bathroom, kitchen and sometimes communal sitting room are shared. Gaijin house advertisements are to be found in the free English language press.

Side Effects of Making Money Online at Home

Today most of us who work online and make money at home face many peculiar problems which are specific to those who work from home on internet. These drawbacks I think will take a large shape in next few years when most people in society will start working at home online. Earning money online at home which is today just beginning of a trend and most of its drawbacks are undiscovered and unstudied. This trend of working from home and earning money online can pose serious threat to our social structure other than a number of problems for individual at family level. Working from home on internet is like working in a virtual environment and virtual office, where everything that exists now may not exist tomorrow or even after a few minutes. These

1. No time for family or All time for family: All those who earn money working at home face this problem. It is very difficult to balance online work and family issues. There are times when there is no time for online work as one gets engaged in one issue after another at home, and it becomes really very difficult to concentrate on online work. On other occasions when an online worker is busy in some online project for hours and days he hardly finds any time for family. Although he is at home he isn’t aware of what is going on because he has developed a workplace, an office environment at home and whenever he is free he tends to think about his online work and earning money.

2. No time or place to relax : Home is a place called ‘Home sweet home‘ now if we are working full time in this place, within the space that was earlier meant for relaxation. Earning money and doing work often comes with stresses, which come and go but with ‘online work at home’ all these things happen in a place where we used to relax. During stressful period there is no time to relax, as the solution to the problem lies in more work and spending more time online. Next is the problem of place to relax, it is very difficult to find relaxation in the same place where you work even if its home.

3. No social interaction : When we earn money online by working at home, we hardly move out of the house, because if we are earning good money, we’ll like to work more and earn more money due to greedy human nature. On the other hand if we are not earning any money or are losing money then we will like to make some changes and improvements in our work, therefore we’ll spend some more time online at home. This means we don’t interact with society, we spend our time in online societies which are virtual. This is one of the major drawback which will bring a major change in social structure as people will work at home and spend time online, resulting in a poor and meek society. A subject of interest for social scientists.

These are some of the side-effects of making money online at home, may be these are not thought provoking but they do exist and have a major impact on both our earning money online and working at home. This article is just a brief outline and just a preliminary report. These issues must be considered before starting a full time home based earning program, as everyone can’t make adjustments all the time even if he is earning good money online working at home.