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.

Reasons For Pregnant Women to Wear Maternity Clothes

For many women, pregnancy is a very exciting and exciting time in their lives. Through the pregnancy period, a woman undergoes many physical and emotional changes. When a woman begins to gain weight, she can experience physical discomfort as well as feeling less attractive. The inability to wear one's regular clothes can result in frustration and sadness. The importance of wearing maternity clothing is essential to making a woman look and feel good through the entire term of her pregnancy.

When one thinks of maternity clothing, they often think about drab, unattractive, and baggy clothes. Fortunately, there are maternity clothes on the market that are designed to display quality, comfort, durability, and fashion. There are hundreds of online retailers and traditional 'brick and mortar' stores that sell quality and comfortable maternity clothing.

Physical changes an expectant will include include: gain in weight, larger abdomen, and swollen ankles and fingers. Many maternity clothing providers understand the need for a comfortable pair of maternity pants. Many maternity pants can be worn through or nearly all of the pregnancy term. Maternity pants are available in a wide range of colors, styles, designs, and patterns. They can even include jeans with stretchable waist bands. Maternity pants are sold in a broad range of styles and comfort levels. The stretchable elastic waist bands allow an expectant mother to relax. As well, there are pants that are designed to give a slimming effect.

A pregnant woman can still wear stylish brand name dresses. There are maternity dresses for any time of social setting such as at a formal function or just relaxing around the house. One can wear sun dresses, short-sleeved dresses, long-sleeved dresses, strapless dresses, casual dresses, short dresses, or full length dresses. They come in many styles, colors, designs, and patterns. They are designed to make a woman feel comfortable and feminine, while looking fashionable and they take a maternity photography.

Maternity tops can come in a variety of designs, styles, and colors. These tops are comfortable and fit well to the growing abdomen. They are deigned for current and changing fashion trends. They will make a woman feel attractive as she increases in weight.

Swimwear is another popular form of maternity wear. Popular maternity stores that offer maternity swimwear include: bikinis, one piece suits, and bathing suit bottoms. A pregnant mother can enjoy herself sunbathing or swimming. There are a range of maternity swimwear companies that sell swimwear designed by top selling brands.

A pregnancy does not mean one has to wear dismal clothing. There are many top brands that sell chic and trendy maternity clothing such as Old Navy Maternity, Motherhood Maternity, Gap Maternity, and much more. Wearing trendy and stylish maternity clothing through a pregnancy can make a woman comfortable and attractive, thereby allowing her to focus on the arrival of her new bundle of joy.

An expectant mother's pregnancy does not have to have a time of discomfort and feeling unattractive. There are now many popular brand name maternity wear companies that sell a variety of stylish and comfy clothing to meet the needs of every expectant mother.

5 Tips to Avoiding Travel Eczema

Your eczema has been under control for a while. You have attained that sweet spot of equilibrium where your known eczema triggers are understood and avoided, whatever medications you take are working and not causing side effects, your skin is as good as it gets. Only one problem, you will be traveling soon.

Travel eczema, occurs when your body meets up with irritants and allergens you cannot control, as a result of not being on home turf. Whether it’s air, water, food, sun, soaps, detergents or weather, traveling presents some hard to solve problems trying to keep eczema in check.

Sometimes it’s the irritant or allergen you are exposed to that you would usually avoid, that causes the problem. But sometimes, just the change of routine or unfamiliar environments can cause flare-ups. Traveling can be stressful and eczema loves stress.

Here are a few tips to keep eczema at bay:

1) Do a little research into the type of foods you will encounter that are indigenous to the area you will visit. What can you eat, what can’t you eat. Eating the cuisines of other cultures is a major component of travel, and knowing what common additives are used in the preparation of popular dishes is a good way to stay symptom free.

2) Pack enough of your favorite medications, cremes, ointments and solutions. Don’t think you’ll be able to pick some of these up where ever you go. First, some products won’t be available, second , they may be very expensive and third, you don’t want to spend time running a round looking for something to ease your discomfort. If you travel to a tropical climate and you start to experience eczema symptoms like flaking and cracked skin, these minor openings are perfect places for more serious infections to gain a foothold, if you have the right medication this will not present itself as a problem. Better to have a little extra baggage than find yourself without your wonder creme.

3) Try to drink enough water or fluids, this will keep your system less stressed and better able to cope. I try to drink only bottled water that comes as close as possible to the type I drink at home. Meaning, I drink spring water with a specific mineral/chemical make up, so much sulfur, dissolved salts, etc., so when I travel I don’t drink mineral waters which may have higher mineral concentrations or added ingredients. If you drink German beer at home, then drink german beer abroad.

4) Pack and use an anti allergy travel sheet like an Allersac. Bleaches, detergents, soaps, perfumes are just a few of the triggers a travel sheet will help you to avoid when you spend 30% or more, of your time in a strange bed. An anti-allergy travel sheet, one that can be washed repeatedly, will be your best bet. Make sure, which ever travel sheet you use, it has a pillow pocket to protect against direct contact with the hotel pillow. One of the major causes of allergic eczema is dust mite dander. A travel sheet with a small pore size or one that claims protection from dust mites would be wise.

5) Environmental factors like cold, humidity, sunlight and heat can cause flare-ups especially when it’s the change that is the cause. If you travel to a warm climate from mid winter conditions at home, be prepared. Pack clothing that will mitigate reactions, sunblock, hat, gloves etc. The weather might cause your sinus problem to flare, which in turn stresses your body and causes your eczema to activate, or the humidity allows high mold or pollen counts where you travel. There are websites like http://www.aaaai.org/ which publish pollen and mold counts, and many sites for weather forecasts.

Having eczema and learning how it activates and affects you takes years, some people get a handle on it, others don’t, but even if you don’t know what the causes are, some simple precautions, a little research and remaining calm can help you to get the most out of traveling, even with eczema.

You Can Trust Comcast For Great Telecommunications Services

There are a lot of different technologies available these days that keep us entertained, informed, and allow us to communicate with others, but the big three technologies that accomplish this are the Internet, cable TV, and the telephone. Unfortunately though, in order to get the most out of these three types of technology, and avoid spending way too much money in the process, we can’t get them through just any company. That’s why it’s fortunate that Comcast provides broadband cable high speed Internet access, digital cable TV service, and full featured home phone service. Better yet, all three of these invaluable features are bundled together so that you only have to pay one convenient bill every month. This bill is convenient in terms of only having to deal with one company for all three services and because of the discount that you’ll receive for going with Comcast for all three services.

Several great examples of the value that’s built into services can be seen in the digital voice phone service. For example, unlike conventional phone companies that make you pay extra for any specialty features at all, this company provides the most frequently used bonus features like caller id, call forwarding, call waiting, and voice mail at no extra charge. The real savings come from the fact that you’ll get all of your domestic long distance calls for free. That alone makes this a great service for staying in touch with everyone you care about.

You’re also sure to get a lot of value from high speed Internet service. This version of Internet access relies on the same cable that brings TV programming into your house for download speeds of up to eight megabytes per second. With download speeds like that, the entire Internet is yours to take advantage of. That means unfettered access to online multiplayer video games like World of WarCraft and Second Life (or Club Penguin for your kids). It also means that you can download a wide variety of software applications and updates quickly and easily. For example, if you want the newest version of your favorite web browser- complete with all of the security updates- it’s easily within reach. The same is true for all of the other updates and upgrades that your computer needs in order to remain healthy. A high speed Internet connection will also help you keep track of your finances by making navigation of secure websites a breeze. The same thing will be true for online shopping. They also help you keep your computer safe by providing a variety of security measures including a firewall and free antivirus software.

Comcast in still takes its roots seriously which is why it provides the best cable TV service around with the use of great new types of technology like digital TV, DVR’s, HDTV, and video on demand. Video on demand is a really impressive type of technology that allows you to choose what to watch and watch that content when you want, rather than when someone at a TV network thinks you should watch it. You can take advantage of video on demand technology either through ON DEMAND pay per view service or through the Premiums On Demand subscription service.

Of course on top of cutting edge technology, there are lots of great TV programming choices- over two hundred and seventy five channels in the largest programming package. All of this just goes to show that Comcast provides you with all of your telecommunications needs.