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.

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.

Unsecured Business Loans – Start Marching on the Way of Success

Business loans can show you the right way to be adopted when you are sitting idle and dreaming to be successful. Success and money does not come automatically. You would have to put your efforts for that and trying to be a businessman as a part of such ventures will not be a bad idea. If you think that you can manage to have a good businessmen and have a particular idea regarding the field of your business then you should go for it. To start with this new field you can first set up a small business and the unsecured business loans will be perfect for that.

These loans are well known for supporting businessmen by offering small financial helps. Although the offered amount is not so big but still you would find it quite helpful. In fact, these loans will support you in any business activity like:

– Buying the office or the site for the business
– Getting raw materials
– Buying machines
– Hiring man power or
– Arranging other related things

The rates of interest of these loans use to be a bit high. So, you have to be ready to manage that or else you can opt for another loan too. Such suitable loans are easily available in the loan market. In fact, that does look to be a burden as here you will be freed from offering contractual. Without placing any security you can get the loan away.

All those bad credit records that enjoy getting these loans are arrears, defaults, late payment, bankruptcy, CCJs, skipping of installs and IVA. So, there will be no tension for the poor credit holders too. They too can now get the unsecured business loans and set up their own business. In fact, these loans are good for renewing old and dying businesses too.

What Does the Word Website Designer Stand For?

Today anyone seems to call themselves web designer just because the learned to create a web site.

Is it traditional graphic design involved or is it just experts on programs like Flash, Dreamweaver, etc. who call themselves designers?

One guy looking for work told me he had a web design education and when I looked at his work it was like 5 pages crap made in FrontPage!

For me as an art director and graphic designer it all seems a bit strange. I have spent years in art- and advertising classes, over 30 years in the advertising business in Sweden and Spain and I’m still not sure I can use that title. Even if I have designed hundreds of websites last 10 years.

So be aware when you looking for help, with internet anyone seems to be whatever they like and advertise their services, trust them or not. You will never know for sure.

Today I saw the following ad in a local magazine: “We design web sites for 130EUR”. That guy must be something of a superman. Or is the education these days so fantastic that you can learn it all in a few years?

The “Graphic design” education is just a small part in building your web site.

The natural way was (back in the 80:s in Stockholm) that your advertising agency produced your website and designed it so it fit your company’s profile. A few years later a lot of digital production companies started, but still with people educated in the advertising business.

Short after that anyone with money could buy a computer, copy machines and some colour printers and start a Copy shop without any education in advertising. Unfortunately they after a while also offered help in layout and design.

That’s where we are today. Anyone with a computer can offer you anything online.

It’s up to you to find out who they are.