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I love beer. There, I said it. I’m not making apologies. I’ve been into beer since my college years. While I do admit my taste has been noticeably refined since then, beer is a beverage of which I was fond since my early twenties.

Then, I learned how to make it.

I’ve

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

been homebrewing beer since 1998. It is a very relaxing and fun hobby of mine.

As with a lot of hobbies, there are several levels of investment you can make when starting to brew your own beer. You’re looking at a $30 investment for about the low end and it goes up fro

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

m there. You can spend a lot more, but I started brewing my own beer in the $30 range.

Homebrew beer can be separated into two categories: extract and whole grains. Each has advantages and drawbacks over the other. Extract is syrup that consists of most of the main ing

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

redients of beer. When brewing beer using extract, you simply need water, yeast and some fermentable substance (sugar will do).

The advantages of extract brewing are the cost tends to be cheaper and the time it takes to make beer is less than with whole grains. The disa

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

dvantage is you are basically limited to the formula of ingredients in the extract. While there are many different types of extract for the various types of beers (Stout, Ales, Lagers, etc), the choices are more limited than the whole grain method.

Whole grain brewing is

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

done by boiling and mixing the individual ingredients (malt, barley, and hops) over a longer period of time until the mixture (also called “wort”) is ready for the addition of the yeast and the fermentable substance. The advantage of whole grain brewing is you can really

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

customize the flavor of the beer. Whole grain brewing makes it easier to do things like make a “clone beer”, or a beer that is similar in flavor and style of another well known beer, like Samuel Adams or Budweiser. The disadvantage of whole grain brewing is the addition

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

al time and cost involved. This is probably a good type of brewing to get into if you are more experienced.

Yeast is a very important ingredient in beer. In fact, there are many strains of yeast available for brewing beer (and other alcohol in general). The two types I

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

’ve dealt with are dry active yeast and liquid yeast.

I’ve personally found that liquid yeast, while more expensive than the dry yeast, is the more effective of the two. The type of liquid yeast I use (Wyeast) comes in a foil packet. Inside the foil packet is the yeast

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

and a small plastic bubble filled with unfermented beer. When I’m ready to make some beer, I squeeze the foil packet until the plastic bubble breaks. This mixes the unfermented beer with the yeast and starts a fermentation that gets the yeast active. By the time I have

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

y beer ready, the yeast is good and ready when it is added to the mix. There are many types of liquid yeast available. The yeast is usually named for the type of beer it is better suited for, like American Ale or German Alt. I think there is some room for experimenting

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

here, though.

The dry yeast is cheaper than the liquid variety, and in some cases you get a packet of the dry yeast when you buy a can of extract with which to brew beer. The disadvantage of dry yeast is the variety of yeast strains can be limited, and dry yeast can some

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

times take longer to begin fermentation.

Aside from what I’ve already mentioned, sanitation is one more important factor in making beer. It is very important to have the equipment you use to make beer sanitized. There are several methods to do this. Household bleach mi

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

xed in warm water (1 tablespoon bleach per gallon of water) can handle your sanitizing needs, just make sure you rinse properly after sanitizing. There are other sanitizers available as well. I like One Step sanitizer, which is a rinse free sanitizer. You simply add a t

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ablespoon of One Step to a gallon of hot water and soak the parts in it for 10-15 minutes. After that, remove and they’re ready for use. I also like One Step over bleach because bleach always seems to leave some kind of aftertaste, no matter how much you rinse.

The fina

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

l portion of the homebrewing process, aside from the drinking, is bottling. Again, sanitizing plays an important part here. What is also important to consider is how you want to bottle the beer. Would you like to have one five gallon keg? How about putting your beer in

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

to many 12 ounce bottles? Or, a few five liter mini kegs? Several options are available. I’ve experimented with several options, and my latest favorite is reusing 2 liter soft drink bottles. I like this because it really makes serving to a group of people much easier.

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

Also, storage is a bit easier for 2 liter bottles.

Once you have your bottles, kegs, etc picked out and sanitized, you’ll need some priming sugar for the bottling process. I’ve read a few methods for accomplishing this. One method I’ve found that works well is to bring

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

two cups of water to a boil, mix in 5-6 tablespoons of sugar and boil for 5 minutes. Then, add this to the beer you have been fermenting before the beer is poured into the bottles, kegs, etc. After you’re done, you’ll have beer ready for the tasting in a week or two (at

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

least one week for bottles, two weeks for mini kegs).

If you’re considering taking up beer making as a hobby, I invite you to give it a try. I think you’ll find it to be great fun. Chances are, your friends will agree…as long as you’re willing to share some of your bee

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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