Five Tips for Better Biotechnology Writing

Your company can improve its productivity by improving the writing skills of its technical people. Poor writing skills may not show up on a balance sheet, but they can be a big problem. A one-month delay in getting FDA approval - due to ambiguous writing - can cost a company millions of dollars.

Unclear writing in this industry is understandable. There is so much technical information and so many numbers packed into typical biotechnology and pharmaceutical documents - SOPs, investigative reports, technical assessments, nonconformance memos, and process characterization protocols - that the quality and style of writing often takes a backseat to accuracy.

Many scientists write in fear, teetering between giving FDA too much information and too little. If they give too much, they may be opening up issues that they'd rather not broach; if they give too little information, they can be slammed for being incomplete, evasive, or unaware.

FDA regulators have expectations. They want accuracy, but they also want the comfort that comes from reading a document that sounds authoritative because it is clear, error-free, and easy on the eyes. Poor writing - loaded with vagueness or wordiness or lacking parallelism and correct punctuation - can negatively influence any reader, including those who hold the fate of an application in their hands.

Five tips address the biggest writing problems among biotechnology professionals. (Other writing problems abound, so consult the "Better Writing Resources" sidebar for useful guides and reference materials.) Each tip is bolstered by examples drawn from actual documents (blanks are used to maintain confidentiality).

Organize your information

You can't afford to wing it. You need to plan the order of your thoughts, then reveal that plan to your reader. Use a summary to announce your topic as well as to set forward a mini-map of where you are going. Readers will follow you almost anywhere if you tell them ahead of time the order of your topics. The use of outlining, subheads, and anything else you can do to let readers know your aims in the next few paragraphs or pages is very helpful. Don't start with a long-winded dissertation on the background of the project or experiment. Instead, get to its purpose - what, why, when - before you start going into too much prefatory material.

Be concise

Conciseness is not the same as brevity. Brevity means being brief; conciseness means using the fewest words to get your message across. Here are a few examples of wordy sentences followed by concise revisions:

Original: "A minimum pH of 6.87 was observed during the process."

Revision: "During the process, the lowest pH was 6.87."

Original: "In order to meet the demands of the ______ industry, alternate methods of _____ must be developed."

Revision: "To meet the demands of the ______ industry, alternative methods of ______ must be developed."

Comment: In this revision, I cut two words and also changed "alternate" to "alternative," which is the word I believe the writer is after. Mark Twain once said, "Use the right word - and not its second cousin." "Alternate" strikes me as "the second cousin" because it means "to occur in successive terms."

Original: "The pH went down to 6.83 by the time corrective action was taken."

Revision: Use "fell to" or "dropped to" instead of "went down to."

Comment: The original sentence shows poor word choice.

Original: "Process characterization of the commercial manufacturing process can help ensure efficient validation, consistent process performance, yield improvements, minimize process excursions and aid in the investigation of process deviations."

Revision: "Characterization of the commercial manufacturing process is important because it ensures that validation is efficient, performance is consistent, and yield is improved as well as process excursions minimized and investigation of deviations aided."

Comment: There is no reason to settle for the repeated use of the word "process" throughout that sentence. Also, the revision helps keep the thoughts parallel. In other words, instead of some thoughts starting with verbs (ensure) and others with phrases that sound like nouns (yield improvements), all of the phrases should start with either verbs or nouns. You should not mix-and-match the two.

Keep it simple

There is no need to use big words when small ones will do. Obviously you must use big words if they are the right words - such as the names of products, chemicals, or other proper names. However, try to take some of the starchiness out of your writing by asking yourself if a simple word would do as well or better than the word you've chosen. For example:

Original: "A scaled-down model for each unit operation must be qualified prior to initiating process characterization experiments."

Revision: "A scaled-down model for each unit operation must be qualified before starting process characterization experiments."

Comment: "Before" communicates the same information as "prior to" but more directly.

Be specific

Even highly intelligent technical professionals occasionally get lost in their own thoughts. When this happens, they may write a phrase that is fuzzy and hard to picture. Usually, if an editor asks a writer what he or she means by a particular phrase, the writer will provide a new phrase that clears up the problem.

If documents aren't checked carefully, you may come across a phrase like the following one taken from an investigative report:

Original: "These experiments were scaled up to a large scale for final _______ production."

Revision: "These experiments were scaled up to commercial production."

Comment: Scaled up to a large scale? What exactly does that mean?

Don't leave phrases like "scaled up to a large scale" to the reader's imagination. When it comes to FDA reviews, vagueness is held against you.

Check for errors

Don't assume that small things like punctuation and grammar aren't important. They are. They can distract the FDA regulator reading your work. Punctuation and grammar help give consistency and clarity to your work. There have been many occasions in which the slip of a comma or hyphen can yield disastrous results. But even if your punctuation errors are not that awful, you should get rid of them.

For example, here's a run-on sentence from an executive summary:

Original: "The proposed method of ________ production has a potential to meet the ________ needs of the meat industry, hence it is highly recommended."

Revision: "The proposed method of ________ production has a potential to meet the ________ needs of the meat industry; therefore, it is highly recommended."

Comment: The comma has become a semicolon that breaks up the run-on sentence. Just for good measure, the antiquated word "hence" was changed to "therefore," a more modern transition showing consequence.

I see five regular punctuation errors in biotech and pharmaceutical writing.

1. Failure to use a comma after an introductory clause:

Original: "To meet the regulations of the food industry personnel must be properly trained."

Revision: A comma should be inserted after "industry."

2. Failure to use commas to set off parenthetical phrases, follow introductory words, or join a dependent clause:

Original: "Also by purchasing a bigger ion exchange column the total purification time would be decreased making the overall production more efficient."

Revision: "Also, by purchasing a bigger ion exchange column, the total purification time would be decreased, making the overall production more efficient."

Comment: The author of this technical report left out commas.

3. Failure to put hyphens between two or more words acting as an adjective:

Original: "The facility houses state of the art upstream and downstream equipment."

Revision: "The facility houses state-of-the-art upstream and downstream equipment."

Original: "post SIP pressure"

Revision: "post-SIP pressure"

4. Failure to use "and" instead of an ampersand:

Original: "stop & start collects"

Revision: "stop and start collects"

Comment: All rules have exceptions. We regard R&D as proper usage.

5. Putting numbers in parentheses for no reason:

Original: "Perform ________ on the (3) eluates from the characterization runs."

Revision: "Perform ________ on the three eluates from the characterization runs."

Better Writing Resources

Medical Writing in Drug Development by Robert J. Bonk (Haworth Publishers, 1998). This book details a college-level course in pharmaceutical writing.

The Elements of Technical Writing by Gary Blake and Robert W. Bly (Pearson Education, 1993). This is a popular style guide for a wide range of technical documents.

Society of Technical Communication is the world's largest professional association for technical communicators. Contact this organization via its website: www.stc.org.

The Communication Workshop, www.writingworkshop.com, offers onsite technical writing seminars and one-on-one training by phone, fax, and e-mail.