Following a successful trial last term, Butterworth Labs is set to extend its partnership with Kingston University. Starting in October 2024, students pursuing Chemistry and Pharmaceutical-related degrees will be welcomed to Butterworth Labs’ Teddington site.

During their visit, students will participate in a presentation about the lab’s work, take a guided tour of the facilities, and engage with lab managers in a Q&A session. The visit will also offer students the opportunity to explore potential career paths within the pharmaceutical industry, providing valuable insights into future careers in science.

Cellulose assays that utilise capillary and packed column gas chromatography reduce the risk of out-of-specification results, while also improving the accuracy and quality of the data generated.

At Butterworth Laboratories, gas chromatography (GC) is used for accurate cellulose assays of substances like hypromellose and methylcellulose. The method, aligned with pharmacopoeial standards (USP, PhEur, JP, ChP), provides reliable testing and improved precision for clients.

While capillary columns offer sharper chromatographic results, the packed column method has historically shown better repeatability for certain analytes like methyl iodide. To mitigate risks, BLL has set stricter %RSD limits of NMT 1.0%, ensuring more reliable data and minimising the likelihood of out-of-specification (OOS) results.

To read this white paper, click HERE.

2024 marks an important year for Butterworth Laboratories as this year we celebrate our 50^th Anniversary.  Since 1974, we have grown from a small local business, trading as The Butterworth Microanalytical Consultancy Ltd, into a leading provider of contract analytical chemistry testing. We serve clients around the world with our know-how and exceptional service, becoming known as Butterworth Laboratories Ltd in 1978.

Our journey over the past five decades has been driven by a commitment to quality, collaboration and continuous improvement.  What started with a handful of dedicated employees has flourished into a team of over 80 talented professionals, all working together to uphold our core values of integrity and excellence.

As we celebrate this historic occasion and reflect on our rich legacy, our vision remains clear: to build on our strong reputation and continue providing outstanding services to our valued customers.

On behalf of everyone at Butterworth Laboratories, I would like to thank all of our customers, past and present, for supporting us and being an important part of our story. We look forward to continuing to work with you and providing our excellent  levels of services in the future.

Note: the photo above was from the original laboratories at the 41, High Street site in 1974 and below is the front page of the first brochure.

Excipients play a fundamental role in API delivery, and John Welch, Butterworth’s Associate Director of Business Operations, believes that their testing is key to ensuring the safety of pharmaceutical products

In the pharmaceutical industry, excipients can make up as much as 90% of a drug product, meaning their quality and safety are just as crucial as that of APIs. The misconception that excipients are “inactive” can lead to overlooking potential risks, such as contamination from impurities or recycled solvents.

To read the full article published in Manufacturing Chemist, click here.

As helium supplies face pressure, alternative solutions and regulatory changes drive industry adaptation.

Helium, the second most abundant element in the universe after hydrogen, is produced in stars through nuclear fusion. However, on Earth, helium is relatively scarce. It is primarily generated by the underground radioactive decay of uranium (238 U). Over time, this helium migrates through porous rock formations and eventually escapes into the atmosphere, where it dissipates into space. Due to its physical properties, helium is the only substance that escapes the atmosphere and is lost in space. Because of its inertness, if this were not the case, the concentration of helium in the atmosphere, which is stable at about 5.2 ppm, would constantly rise as the formation of geological helium continued.

To read the full article published in Manufacturing Chemist, click here.

Butterworth Laboratories’ latest article, published on the Pharmaceutical Technology website, explains why the latest guideline is significant in analytical procedure development for pharmaceuticals.

To read the article, click here

At Butterworth Laboratories, we prioritise our employees’ mental health and well-being. As such, we are happy to support Mental Health Awareness Week. As a company, we’ve established a dedicated program to train mental health first aiders who can provide support to individuals facing mental health challenges.

Currently, we have 7 members of staff who have attended the St John’s Ambulance training to qualify as Mental Health First Aiders, where they learn to recognise warning signs of mental ill health and develop the skills and confidence to approach and support someone while keeping themselves safe. 

Our impression and speaking with other exhibitors, it felt as though the number of delegates attending was greater than has been the case since the Pandemic etc. As usual it was good to meet up with clients, regular exhibitors, competitors and old friends and colleagues.

Frank Judge, our Consultant Chemist – Chromatography made his presentation titled: Helium Crisis? on the first morning, which appeared to be well received by the number of delegates speaking to him and asking him about moving from Helium to Hydrogen as a carrier gas in Gas Chromatography. His PowerPoint slides can be downloaded here.

We have signed up to exhibit again next year and, in the meantime, will be at the Making Pharmaceuticals Ireland in September.

THE DETERMINATION OF NINHYDRIN-POSITIVE SUBSTANCES IN PhEur AMINO ACIDS

Our Projects department has now successfully verified 15 out of the 21 amino acids listed in Free Amino Acid Monographs using our Hitachi high-speed Amino Acid analyser.  This work will continue until all 21 amino acids have been verified and we’ll keep you posted on our progress towards this goal.  Please take a look at our White Paper on this subject and also our website for an updated list of the currently verified materials

Frank Judge has also written an article published by Pharmaceutical Technology titled: A review of changing regulatory and analytical requirements of free amino acid monographs of the European Pharmacopoeia.

To read the article: Click here

MAKING PHARMACEUTICALS 2024

Butterworth will again be exhibiting at the Making Pharmaceutical Exhibition in Coventry at the end of this month.  Frank Judge will be giving a presentation entitled ‘Helium Crisis’ on the first morning.  He will then be on our stand to answer any questions about the presentation and how to move from Helium to Hydrogen as a carrier gas in GC methods.  If you are attending, please come and see us on Stand 315.  If you are not already registered to attend as a visitor: Click here

JPAG MEETING

Mala Patel and John Welch attended and exhibited at the latest JPAG meeting on Considering the Raw Materials.  The most interesting point highlighted was that the Death Rate as a result of contaminated cough syrups with Ethylene Glycol and Diethylene Glycol is now as high as it has ever been.  It was suggested that organised crime might be putting profit above safety, which is very difficult for Regulators and Auditors to deal with.

Butterworth highlighted the issue of contaminated cough syrups with Ethylene Glycol in an article published by Pharmaceutical Technology last June: Contamination of Drug Components and Products with Ethylene Glycol and Diethylene Glycol and in our whitepaper titled The Importance of Excipient Testing.

PROJECTS

One of the biggest frustrations communicated to us by our clients is the competing priorities in their labs regarding scheduling non-routine work, such as method development, verifications, and validations.  When deadlines are looming and you are not making the progress you need, we can ease the pressure.  Our bespoke solutions, underpinned by our 50 years of expertise with dedicated project managers and analysts, can provide you with a cost-effective and hassle-free service.

We have been working hard to control and reduce our Projects costs and are keen to pass these benefits on to our clients, so why not contact our Projects Team to learn more about the benefits of collaborating with Butterworth Labs?  It may not be as expensive as you might think!

LATEST INVESTMENTS

The laboratory has just taken delivery of hydrogen, nitrogen, and zero-air gas generators.  These will assist us in helping our clients move their GC methods from Helium to Hydrogen carrier gas, which our Projects Department would be happy to talk to you about.  The move to gas generators, from bottled gas cylinders, will also help our drive to become a more sustainable laboratory and help us reduce our costs.

In addition, our Projects Department have been leading a change control process for the purchase of a new LC-MS and an order will be placed by the end of this month.

STAFF NEWS

John Gearey is stepping down as Finance Director & Company Secretary after 24 years and Paris Sheppard has been appointed to this role.  John will continue on the Board as a non-executive director. 

Nigel Gradwell, who worked in our Projects department, has retired after 21 years of service at Butterworth in several roles.

We wish John and Nigel all the best in their retirement.

BLOGS

Since the beginning of the year, our staff have been writing interesting blogs about our work.  These include:

• Let’s put the TLC back into TLC
• Recycled fire suppressant specifications – is there a case for revision?
• No more burned fingers and the roots of residual solvent analysis at Butterworth
• The background to Residual Solvent Analysis at Butterworth 

The blog on Fire Suppressants led to the author being asked to attend an ASTM D committee meeting.  This was to provide analytical expertise on a potential new standard due to our long history of analysing these materials.

Please follow us on LinkedIn to receive future blogs that may be of interest, as well as notifications of articles and whitepapers published by Pharmaceutical Technology and Manufacturing Chemist etc.

Come and join us at the JPAG Meeting being held at the Royal Society of Chemistry, Burlington House, London at the JPAG Meeting on 21st March 2024.

Raw materials, APIs and excipients play an important role in the manufacturing of pharmaceutical products therefore it is important to assess and monitor quality of these materials throughout the product lifecycle. This symposium will present an overview of testing and risk assessment of these pharmaceutical product components throughout the life cycle with presentations and a panel discussion covering topics related to our key themes below:
– pharmacopoeial monographs for assessing raw materials
– regulatory perspectives (ICH Q7, ICH Q11) covering aspects for small molecules, biologics and ATMPs
– risk assessment of raw materials
– Good Manufacturing Practice
– physical testing including incoming receipt of API & excipients
– method optimisation and development
– stability of APIs
– supply chain impact & resilience
– sustainability

Speakers:
Dr Ralph Adams – Manchester University & RSC NMR group
Dr Hisham Al-Obaidi – University of Reading School of Pharmacy
Rodrigo Arias – DFE Pharma & IPEC Federation
Iain Moore – EXCiPACT asbl
Richard Smalley – Consultant and QP Assessor
Trevor Watson – MHRA
Michael Whaley – Medicines and Healthcare products Regulatory Agency (MHRA)
Antonia Wierzbicki – Waters

For further details, Click Here