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.

Birthday Gag Gifts

A gag gift for a birthday is way cooler than an ordinary, useable gift. Give the following gag gifts to your loved ones, and see how the person will love you more.

For the always late officemate, give him a backwards clock. Written in reverse, this clock will definitely drive your officemate nuts in no time.

For your conceited teenage sister, give her the laughing mirror. This is the mirror that will laugh every time someone grabs hold of it and looks into it. Your sister would definitely love you more when she gets laughed at by the laughing mirror!

Give fake cat poop to your obsessive-compulsive friend. Scatter it all over her bedroom floor, or, better yet, on her mattress to make her birthday complete.

For your love-sick aunt, give her the art of kissing book. So when she reads it, she gets to crave someone to do the kissing with. For additional fun, include the barf-scent breath freshener so she can enjoy her kissing moments even more!

Your long-haired rocker friend describes the bald head wig. This way, he can have the feeling of having a shaved head for a little while. Or maybe he can even pretend to be a hard-core punk!

The exploding lighter coupled with the exploding cigarette pack is perfect for your buddies who incessantly smoke every time you are together. Nothing will make their day better and your day more hilarious than playing this great prank on them!

If you want your loved ones to love you even more, make sure you give them meaningful gifts that will stick in their memories for the longest time. For that to happen, gag gifts are your best choice.

What Is Digital Marketing and How to Use It

You will have to devote lots of time marketing yourself and earning referrals. Content marketing thus will be more prone towards user-generated, instead of professional, content within the next calendar year. The secret to content marketing is that the content has to be interesting to your audience and will supply value to them.

There are a number of reasons to put money into influencer advertising. It is a way to get past the need to use ads to reach your audience. Though email promotion is highly effective, not all startups can harness the real power of email marketing.

Digital marketing isn’t rocket science. It has no boundaries. Since you may see, digital promotion is a big and complicated topic. Digital Marketing is a huge subject and you cannot turn into a hero in 30 hours! It is a type of marketing technique where the marketing activity is carried out with the help of channels and platforms available on the internet. It uses the internet as a main promotional medium, in addition to traditional TV and radio.

It is one of the fastest growing industries so there is much room for growth and development. It is one of the top 5 growing sectors since the year 2009. In simple terms, it is the promotion of products, services or brands via digital marketing channels. It is much more advanced than the traditional style of marketing because, One has to be very careful in selecting the right strategy to generate reach.

Getting your very own digital advertising and marketing blog is able to help you set yourself apart from others in the business and stand out when you should speak to an influencer or potential employer. The ideal marketing influencers are individuals who speak and reveal themselves in front of individuals.

Your email marketing strategy will vary a lot based on the essence of your small business. Needless to say, there are a number of different reasons your data-driven advertising and marketing strategy could fail in addition to a deficiency of comprehensive tools. It’s simple to separate your digital advertising strategy into various channels like pay per click ads, social networking, search engine optimisation and so forth. A digital marketing and advertising strategy does not necessary demand a detailed analysis, it merely takes a set of objectives and goals which you are seeking to realize. You should develop a content marketing strategy based not just on the info you need to give your clients, but also based on your understanding of what information people are trying to find.

Your digital marketing and advertising strategy might incorporate elements of all 3 channels, all working together to assist you achieve your objective. An intelligent and powerful digital marketing and advertising strategy has many faces. Then you’ll have a fully integrated digital marketing and advertising strategy.

Developing a digital marketing and advertising strategy does not need to be hard work. Based on the scale of your organization, your digital marketing strategy might involve a number of objectives, but coming back to this easy manner of thinking about strategy will be able to help you stay focused on meeting those objectives. It needs to deliver the right content based on their buying stage. A clearly defined digital marketing and advertising strategy encourages existing customers together with new customers to engage and stay loyal.

You need to construct a marketing system which focuses on a group or groups of individuals. The key issue is to develop your promotion system with the most suitable expectations. Fortunately, marketing software has come a very long way in the past few decades, and there are a lot of tools which may help. Ask yourself these questions before you pick any new marketing and advertising tool. You are going to learn how to use the digital instruments and techniques effectively for a prosperous campaign. In other words, it’s because digital instruments and skills have an established capacity to create revenue, and companies wish to harness that power and keep competitive.

Using digital radiography has rapidly increased in recent decades. You could also take advantage of sophisticated email marketing software to run targeted campaigns with an objective of convincing your audience to have a particular action such as signing up for a class, buying your goods, attending an event, or in any case may be. It explains using email marketing, online affiliate marketing, Facebook marketing, and the way to use social networking tools like Twitter, podcasting and blogging.

Sand From the Beach – How to Clean & Keep the Sand Out of Your Home & Car From the Beach!

Sand belongs on the beach and not in your car or home. Everyone loves the beach, but unfortunately the sand loves to follow you when you leave. Though it is virtually impossible to keep every grain of sand on the beach and not in your car or home, a few basic steps can tremendously lower the amount.

1. Always wear sandals on the beach and not shoes that can trap sand.

2. Always carry toys, magazines, snacks, towels and other beach accessories in a mesh bag to allow the sand to fall out verse getting trapped in the bag to eventually end up in your car or home.

3. Place a tote in your trunk to place all beach bags, towels and chairs. The tote can be taken out of your car when you get home to wash off everything inside it.

4. Keep a small hose with attachment to wash feet off before entering your home.

5. Keep a bowl with water by the door and a towel on a hook. Clean your feet off before entering the house when coming home from the beach by sticking your feet in the bowl. Remember to put fresh water daily in the bowl to prevent bugs from attracting like mosquitoes.

6. Consider buying the Hoover Nomad Cordless Pressure Washer. Great to keep in your trunk to hose off feet, toys or chairs before getting into the car. This small unit holds 3.5 Gallons of water and is great at the beach, sporting events and anything imaginable outdoors. Long hose, 90 PSI and long battery life.

7. Keep your doormats by your home clean and new. Doormats do a tremendous job in attracting dirt when newer. Shake out regularly and spray down with a hose periodically. Keep your indoor mats clean daily and wash them weekly.

8. Consider an outdoor changing area to allow sandy bathing suits to stay outside and not inside a bedroom or bathroom. Rinse off the suit before bringing in a home.

9. Have a good stick vacuum near your entry areas to the home to capture the sand quickly. The three best stick vacuums are the Hoover Platinum Stick Vacuum, Oreck Rechargeable PR8000 and Karcher Sweeper.

10. The best vacuums indoor for capturing sand once inside the home are the Oreck XL 2000, Hoover C1404 and Koblenz Upright Vacuum.

The beach can be a very relaxing experience. Following these steps can make leaving the beach less stressful by bringing less of the beach sand home with you.