Incognito: You Can't Do Everything

Incognito advises on the benefits of outsourcing in the analytical laboratory. What could an external partnership mean for your laboratory?

Whether you work in research, quality control, manufacturing support, bioanalysis, or biopharmaceutical analysis, at some point you will face a situation in which you don't have the knowledge or equipment to generate the information required. So, once you get used to the fact that you aren't superhuman, you'll need to set about generating the information in collaboration with others. How you go about doing this has changed significantly in recent years.

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If you don't have the correct equipment to provide the information for your client, it is a reasonably straightforward decision to work with external partners, either within your organization but geographically remote, or outside. The next step is to identify the partner to work with, which can be fraught, and will usually involve your outsourcing or procurement department, recommendations from colleagues, a call to your usual outsourced provider, or, worst of all, a google search.

I've been in this position many times: I know what information I need, and I know how to get it, I just need someone with the correct equipment. I keep coming across the situation more and more frequently as companies look to assess their internal costs and transform their analytical laboratories into outsourcing coordination departments. Here I always apply the "plumber" rule — if you know someone who has had similar work done by an outsource provider and was happy with it, then that is as good a test as any. I've learnt over the years that there are many laboratories and consultants who have great websites, great literature, and great sales (business development) folks but whose scientific expertise does not live up to expectations. Surprising? Don't tell me you never had a bad outsourcing experience or don't know someone who has?

In the present case, where you have the knowledge but not the equipment inhouse, it can be more straightforward. You know what you want and can, to some extent, work with the external provider to ensure the data they will be sending you is fitforpurpose. You can then take this data and turn it into information for your client.

However, what about when you don't know what is required to generate the data or information required by your client? Perhaps the best lead you have is an application note or journal article. In a case like this you need to be very diligent in finding a partner who has the knowledge, skills, and equipment to generate data which is fit-forpurpose. Here I apply the following logic — if this is the first time through for the partner laboratory, then you need to find a different partner laboratory. If the partner laboratory asks you for a method, this suggests that they haven't performed that type of analysis previously, and therefore may not be so "expert". Choose a partner who you are confident will provide you with information rather than data — it's worth repeating this point because inference in analytical science is often as important as the absolute nature of the data. The fact that an impurity exists in the sample but that it's insignificant in toxicological terms or in terms of the synthetic route, for example, is worth knowing.

I have always found that the larger contract organizations are excellent for larger (higher throughput) bodies of work, but if you need more specialist work done, then don't be afraid to go small. In my experience, and for many different reasons, the economies of scale don't always wind up with the finest minds working with the finest equipment in the largest organizations. There are many good people working with smaller outsourcing organizations, and over many years I've built up a little black book of folks who I know will deliver certain types of analysis in the very best fashion.

The general concept of outsourcing your outsourcing can work well and save you a lot of time. There are a couple of good services of this type who simply know who to go to for certain types of analysis — a kind of Yellow Pages but with a really experienced editor! I called them a couple of weeks ago and asked who was the best flavour analysis house in the country. They put me in touch with someone right away — and I have to say if there is a better flavour analysis service available I would be surprised! The provider had already completed a very thorough audit of the laboratory which meant I only had to produce a very short audit verification document.

I've developed several rules when working with outsourcing partners — which I thought may also provoke thought from our readers:

1) Membership of regulatory bodies and legislative compliance (GLP /ANAB/EPA DWLCP/PQRI committee members) is always indicative of not only quality but also the degree to which the laboratory has an "inside track" on the most recent developments.

2) Experience and references: Whenever I've asked for a reference, I always take them up, and few companies ever have a problem discussing the quality of work provided, even if the work itself was performed under the terms of a non-disclosure agreement or confidential disclosure agreement.

3) For longer projects, draw up a roadmap with waypoints, and make sure each waypoint is either a financial or scientific exit point or both.

4) Make sure the roadmap is translated into a protocol (or protocols) for the work — and remember that you know your business and the context of the analysis, so if the proposed experimentation, analytical route, or expected data doesn't feel right, it probably isn't.

5) Ensure that before any work begins you have three things in writing a) the deliverables, b) a mechanism for protocol change, and c) the terms under which you can dispute data or information provided.

6) Above all, COMMUNICATE WITH YOUR OUTSOURCING PARTNER.

The above list may seem a little draconian, however, in my experience these things are necessary and the last point is the most important. I always assume that if I haven't heard from the outsourcing laboratory that things are going badly, so schedule a regular review call that fits with the length of the project.

Finally, the word "consultant" doesn't necessarily equate to "overcharged". This might have been the case in the 1980s, but now there are many good people who are willing to do the outsourcing at your laboratory, and this works particularly well for shorter projects. Having everything done in-house often means less time spent in transferring methods, which is a more efficient way to learn new skills and the spin-off benefits can be great. We did some "insourcing" with a consultant recently who wound up giving us some impromptu software training and optimizing an instrument that we had really struggled with — all as part of their deal and at a fraction (literally) of what it would have cost us to outsource the work.

Between 2012 and 2013, analytical outsourcing in the pharmaceutical industry rose 11% from 34% to 43% (of companies undertaking significant analytical outsourcing).¹ I see the same trend being repeated across many of the industries that I work with. Few companies can afford to invest in a full service analytical facility with all of the associated personnel and equipment, and I foresee a large increase in analytical outsourcing for both high throughput and specialist testing.

Start building up your little black book right now!

Reference

1. Nice Insight Pharmaceutical and Biotechnology Survey 2012/13, www.niceinsight.com

Contact author: Incognito

E-mail: admin@chromatographyonline.com

This article is from The Column. The full issue can be found here:http://images2.advanstar.com/PixelMags/lctc/digitaledition/July24-2014-uk.html#2