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.

Looking for information on Analytical Development and other related resources?

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.

Make Money With Niche Marketing

You can have a good income with niche marketing, but you will have to do a certain amount of work each month to keep the site up to date.

It is interesting that many people try to start their online business by selling products on how to make money online when they are not successful themselves. But there is a lot of money to make online when you start to work in non Internet Marketing niches.

The best way to earn a good income is to have either a website or a blog which you host on your own website. That way you can have total control on what you include.

Once you have decided on your niche, you need to either write your own content or have some written for you. Then you need to have some products to promote.

Now you might think this is harder to do than it actually is. Stop, and think for a moment, if you are careful about your weight, how many diet books you have bought. You may have bought many that you have never read. But anyone with a weight problem will buy every diet book in the hope to find that secret diet tip that will get them slim overnight or in a short time without any work.

When a person is passionate about a subject, they will be ready to buy anything that will further their knowledge in that niche. Time and time again, people are doing this offline, and they will not change their habits because it is now online.

It may take time for them to build up confidence in you and your site, but with good quality information they will soon be aware of how trustworthy you are.

Within your niche you will learn other areas that people want, and will be able to promote those items as well. As you develop your niche site, you will be able to move into more and more products, and you will find that you are able to earn more and more money online.

Once you have a good plan, start created as many niche sites as you can, while maintaining a high quality standard. It's OK to start off small. If you can create one 5-page niche site a week, you will be doing very well.

There is money to be made through niche marketing but like any business online you will need to do some work.

Technology in Education

Technology has moved at a fast pace over the last decade. Wouldn’t you agree? As a result, many technologies have replaced the need for human resources in some fields, and it has also impacted education drastically.

Before delving into the impacts of technology on education however, consider:

· How travel agents have been largely replaced by online reservation systems.

· In 1901, Charles Holland Duel stated that “Everything that can be invented has been invented”. This was over one century ago, where numerous inventions had yet to be patented and trademarked.

· The number one focus on this list of technological impacts, is how computers and the internet has affected lifestyles and education. Everything can be shared in an instant, and snail mail is no longer the main method of communication. In the past one had to wait a few days before receiving a message, unless a phone or fax were used.

In the 21st century, educational institutions have moved with the times by integrating technology into learning. After all, our educational systems are a critical part of societal norms.

Here are some of the key ways that technology has broadened teaching horizons:

Traditional colleges have adopted online methods of learning, which is otherwise known as online colleges. No longer do students have to relocate from thousands of miles away to get a quality education. All that’s needed is a computer and connection to the internet to plug into online learning.

This has opened up numerous doors for working adults who have previously been restricted by time and resources. The technology of online videos or recorded tutorials allows students to study on their own time, whether day or night.

A study by US News purports that nearly 6.1 million students were enrolled in online college course in 2011. This number is expected to grow as the stigma of online certification has somewhat been lifted due to its increasing popularity in the workplace.

Other ways that technology affects education include the student’s ability to research faster than ever, compared to pouring over books in the library. As an example, a study by the Pew Research Center suggests that digital technologies have helped students to become more self-sufficient researchers.

Educators too have integrated technology into learning, with the distribution of course material and online video, voice, or written tutorials for student references.

Finally, there has also been a dynamic shift in the communication between students and teachers via online, social and digital mediums.

How To Fix Sputtering Marketing

Is your marketing generating a steady stream of sales leads?

If not, ask yourself this question: Do you have a marketing plan?

You may know what your business goals and objectives are. And you probably have a website and some advertising. But without a game plan, your marketing activities are reduced to a few unconnected activities that are unquestionably to produce the results you want.

A marketing plan helps you tie all your marketing activities together and keeps you focused so that you can create a roadmap that will lead you to your objectives.

And a simple, one-page marketing plan will take you a lot further than no marketing plan at all.

So what should your plan be based on? You can start with these basics:

1. Identify Your Marketing Goals

What specifically does your marketing need to achieve for your business to thrive? How many new leads do you need each week? What percentage of those leads do you need to convert to sales? What is your revenue target?

2. Create A Marketing Strategy

Take a look at your goals. Now what is your overall approach and position in relation to your goals and competition. My marketing strategy uses an educational approach. By providing people with useful information and ideas, I get an opportunity to demonstrate the value I provide and establish my credibility.

3. Set Up Your Marketing System

Create an action plan. Tie all your marketing activities together into a system that reflects your marketing strategy. The idea is to have everything working together as one.

4. Creation And Implementation Of Your Marketing Activities

Now that you have identified what your marketing activities will be, it's time to take each marketing activity and figure out who will create and implement it and when.

5. Fine Tune Your Marketing Tools

Your marketing activities require the use of one or more marketing tools. These include your website, your marketing messages and things like article marketing. To get your prospect's attention, you need to ensure your marketing tools are really ready to cut through all the marketing noise.

Creating a written plan may seem intimidating but as you can see, you should be able to hammer out the basics in a few hours.