Differences Between a GMP and Non-GMP Lab – Part 2

Method Development

One of Velesco’s specialties is Analytical Method Development. Quite often, we receive a new compound from a client and are asked to develop a formulation and/or HPLC method to be used for analysis.  Sometimes the client will send bits of a method and other times we are able to start from scratch.  When starting from scratch, the lead scientist researches the compound to determine solubility properties and suitable detection wavelength for HPLC.  At times we are able to use the USP/NF for mobile phase, wavelength and column suggestions, however those are typically vague and only give suggestions (i.e. column code L1). Fortunately, Velesco scientists have decades of experience in HPLC, so working from past experiences, we can trial a few columns and quickly select one that gives us the desired chromatography. A fun part of method development is determining if the method will be stability-indicating. Part of testing this is to degrade the compound and analyze the chromatography to see if compound-related degradants are being accurately quantified and separated by the method. Suggested methods of degrading the compound are by light, oxidation, acid, base and heat. It’s interesting to see which methods of degradation produce which degradants. Impurity analysis is also part of method development. If impurities or degradants are co-eluting with other peaks in the chromatography, then something in the HPLC method needs to be altered to have a working method.  Temperature, mobile phase composition or gradient conditions are examples of things that can be adjusted for a change in retention time and can give greater separation of peaks.

A lot of the method development work we do is for research, so it is non-GMP.  At Velesco, we still follow GMP guidelines for documentation, even for development and research work, but we are able to exclude some of the non-essential details from our databooks, which helps to save paper and time.  We usually include the HPLC method and other applicable documentation at the beginning of the databook and then only include them later if something has been changed as part of the development.

Once we have a working method, able to accurately quantify the active ingredients and preservatives and measure degradation/impurities, we can move forward with either method validation or further experimentation with the compound or formulation, both of which will be discussed in future posts.

Event by MichBio – Women Building Success in Biosciences

Hello!  Velesco sponsored a MichBio event this week, June 9, 2015: Women Building Success in Biosciences. See photos here. Three of us ladies from our Plymouth site were able to attend the event, which was fabulous! The event included three panel discussions: Positioning Yourself in Today’s Marketplace, My Life as a Woman Entrepreneur, and Lessons in Leadership.  All of them provided wonderful insights and advice on how we as professionals can advance our success […] Continue Reading…

Stability Indicating HPLC methods – part 1

When we are hired to develop a stability indicating method for our clients, what do we do?

The types of questions that need to be addressed depends on the stage of development that the method will be used for.  First a few basic definitions.

What is a stability indicating method?
A stability indicating method is a quantitative test method that can detect possible degradants and impurities of drug substance (API) and drug products, normally using High Performance Liquid […] Continue Reading…

Differences Between a GMP and Non-GMP Lab – Part 1

Greetings! I was hired on with Velesco earlier this summer after several years of work in cGMP pharma labs, both contract and manufacturing-related. Coming from a cGMP (current Good Manufacturing Practices) background, I’ve noticed a few differences in the way the lab operates when not confined to GMP regulations.  In the next couple of posts, I will discuss these differences.

Coming from cGMP pharma, which I will focus on in this post, I have been […] Continue Reading…

Halloween at Velesco

It was a big week last week at Velesco.  Our building hosted a Halloween party consisting of pumpkin decorating and costume contests.  Beth and I dressed up, but didn’t win anything for our awesome costumes.

Velesco’s evil Santa pumpkin won 2nd place and a MASSIVE box of chocolates!

 

Sarah, holding our winnings!

 

 

Long overdue pictures of Nepal

Velesco’s Philanthropy

Extremely long overdue: a few pictures from my trip to Nepal, eye surgery camp and trekking in the Himalayas.

Cataract camp in Jiri!  There are a lot of happy people about to see for the first time in years.

 

Mount Everest as seen from Tengboche Monastery.

Prayer flags in the Himalayas.