Melbourn Scientific provides contract analytical and formulation services for the pharmaceutical, biopharmaceutical, biotechnology and healthcare industries.
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Congratulations to Dr John Morris who has recently been appointed CEO of the British Aerosol Manufacturers’ Association (BAMA), he is based in Huntingdon just up the road.
Tightening of regulations in the personal hygiene and consumer aerosols sector has increased the need for spray analysis and particle size assessment. This aerosol testing uses many of the same tests and instrumentation that is used for pharmaceutical testing so it has been interesting for us to diversify into this market sector.
The SprayTec laser particle size analyser is particularly useful to this industry and thehttp://www.bama.co.uk/news/89/ is so fast that it can in some cases it can be literally ‘done while you wait’.
We look forward to welcoming Dr Morris to our laboratories in Melbourn, Cambridge, UK.
In its simplest form, dissolution testing provides a basic method of quality control that ensures batch-to-batch consistency. During drug development however, dissolution testing can be used for optimisation of formulations, monitoring drug stability over time and for establishing bioequivalence between formulations.
When considering Quality by Design, the dissolution capability of solid oral dose forms is recognised as a Critical Quality Attribute (CQA). This highlights the importance of reliable, quality data that can only be achieved through expert testing and regular calibration of equipment.
At Melbourn Scientific, all dissolution apparatus is calibrated every 6 months to ensure that it is satisfactory for use and all staff are fully trained before using the apparatus on test samples. Part of the training involves hands on testing of products which can be bought over the counter to ensure familiarity with all aspects of the setup, cleaning and maintenance of the equipment.
Derek Solomon has been promoted to Operations Director at Melbourn Scientific, he has overseen the expansion of the services portfolio, which includes the recent addition of clinical manufacture to an already extensive suite of formulation development services.
Chairman Steve Westcott was delighted to make the announcement and he says: “As a company we have seen year on year organic growth and, despite uncertain economic times, have hit and exceeded our targets.
“This last year has been particularly ambitious; we have completed another phase in the laboratory expansion, extended our manufacturing capabilities following a successful UK MHRA GMP (Good Manufacturing Practices) audit, presented at a major US conference and introduced new bespoke services for accelerating the formulation development process.
“Derek has been instrumental in developing the depth and breadth of our services and it is with pleasure that we welcome him to the board.”
Derek welcomes the new challenge. He says: “We have a strong and committed team here at Melbourn. We have succeeded in embracing new services and techniques without losing the traditional skills in analytical chemistry, which are at the core of everything we do. I am looking forward to consolidating the progress made in 2011 and taking on more challenges in the coming year.”
Melbourn Scientific has seen an increase both in repeat business from its regular clients who appreciate a fast turnaround, and also in demand for special projects from companies at the leading edge of product and device development that need access to specialist experience.
CEO Mark Hammond says that Derek’s promotion will help leverage the company’s capacity for continued growth.
He says: “One of the key drivers over the next three years will be the desire of pharma companies to manage the same level of development projects, but with a diminished internal workforce. As an experienced contract research organisation with knowledge of both the European and US regulatory frameworks we are in a strong position to support these companies.
“The role of Operations Director is new to the company, it will help us to deliver all our projects to a consistently high standard and to see opportunities to offer additional services.”
Melbourn Scientific will again be represented at BenchtoBoardroom, but this year I have decided to mingle instead of taking the exhibition stand.
Having a visual presence to communicate our growing portfolio of contract research services for pharma and biotech clients, is great but there is a pressure not to leave the stand which does restrict the opportunities for networking.
This year I might actually get to hear some of the presentations. Professor Sir Chris Evans will be headlining, he is one of our leading medical science entrepreneurs and has been responsible for 45 high-quality science companies; twenty of which have gone public.
It is good to see the biotechnology sector maturing. We have noticed a growing demand for our analytical and formulation services from the biomedical sector. The partnership approach we adopt with clients has proven very successful in fast-tracking molecules at various stages from lead to launch which is what Bench2boardroom is all about.
We have recently invested in the SOLENT (Solubility Enhancement screening) platform technology and use this within our fast formulation screening service. This can accelerate the development of formulations where poor bioavailability is an issue, allowing analysts to rapidly evaluate a wide range of formulations.
In the early stages of drug development, the concept of ‘fit-for-purpose’ is paramount to an efficient transition from lead optimisation to first-in-man studies. Formulation and testing procedures need to take a fine balance between meeting the requirements for a pre-clinical or first-in-man trial whilst making certain that sufficient data is collated for regulatory purposes.
Using SOLENT within the accelerated feasibility studies will speed up the process and enable the client to identify and obtain a suitable formulation to take forward. Specialist equipment, such as that designed for ultra high performance liquid chromatography (UPLC) also increases productivity by streamlining workflows and processes.
Last year we made some excellent connections, if you plan to be there this year do get in touch.
Benchtoboardroom is on the 6th March at Newmarket Racecourse
Melbourn Scientific is warning device developers and others not to rely on the accuracy of manufacturers specifications for raw materials as there can be major variations between batches. Derek Solomon, Laboratory Manager, comments that suppliers often only do a fraction of their business with pharmaceutical companies and their boundaries are often much wider than is acceptable for GMP (Good Manufacturing Practice).
Melbourn Scientific provides pharmacopeial testing as part of its suite of contract analysis services. The company has recently gained a manufacturing licence following a successful UK MHRA GMP audit and is expanding its facilities for raw material testing, QC and finished product testing.
Solomon warns that raw materials testing is needed at all stages of development.
“Often the raw materials used in early product development are not GMP compliant with the assumption that they will be substituted for GMP grade material as the manufacture is scaled-up. This means that the raw materials are often not given much attention until later in the development process where the implications of impurity content are more costly.
“Pharmaceutical materials manufactured under GMP compliant conditions will be done in such a way that the product and the process are controlled and reproducible. It is not safe to assume, however, that the excipients will be produced in the same way.
“For many raw product suppliers their products are available in bulk to a range of industries and the specification can be changed without warning. This can have major implications for pharmaceuticals and may cause the final product to fail.”
The issue here is that there are no universal standards for commercial manufacturers outside of the pharma industry, and where testing does occur there is a requirement to transfer and validate the method in a GMP environment. Solomon advises that instead of relying on the manufacturers certificate of analysis, pharmaceutical product and device manufacturers should develop their own specifications and test against these.
For nebulised products, the size of the droplet is important in determining where in the lungs the drug will be deposited. Laser diffraction is a useful tool for analysis droplet size.
A source of confusion when discussing nebulised products is the difference between particles and droplets. A particle is a solid, and may be held within a liquid droplet.
In solutions the molecule is evenly distributed, so droplets of the same size will contain the same amount of drug. This is in contrast to suspensions, where the size and concentration of the particle(s) within each droplet may vary.
It is possible to alter the particle size through micronisation and other techniques if required.
For a drug in suspension, where the particles may not be evenly distributed between droplets, the aerodynamic particle distribution must be determined using a Next Generation Impactor (NGI). However, this test is time consuming to perform and analyse, making it relatively expensive to use an NGI each time.
For a homogeneous solution, however, there is a correlation between droplet size and aerodynamic particle size, so laser diffraction can be used, for example using SprayTec.
Here the spray is passed through a laser beam, and the angular intensity of the scattered light is measured. This scattering pattern is then analysed using an optical model to produce a size distribution. This determines the size of the droplets, but does not measure the drug content itself.
Laser diffraction analysis not only provides a droplet size distribution, but also a time-history plot, which gives information on how the nebulised formulation behaves throughout the duration of the nebulisation process.
In addition, the results are available immediately so different formulation variants can be screened rapidly. This accelerates development times and makes laser diffraction a valuable tool in the early stages of product development.
Melbourn Scientific has extensive experience of nebuliser testing and particle size analysis and results from SprayTec analysis can be rapid.
Formulation for a nebuliser – stages of development
- Analytical method development and validation – to include size analysis of particles and droplets, and emitted dose quantification according to the European Pharmacopoeia regulations.
- Analysis of physical characteristics, including hygroscopicity and reaction to temperature.
- Assessment of the API’s stability over time.
- Feasibility study: solubility assessment for the API. For suspensions options for particle-size reduction must be assessed.
- Take a reference standard qualification of the purified API.
- Accelerated stability testing: analysis of particle and droplet size and pH. This should be repeated after 1 month to check stability.
- Nebuliser compatibility studies: measurement of drug-delivery rate, total drug delivered, droplet-size distribution, particle-size distribution.
We have recently expanded our capacity for finished product testing prior to release certification, following particular interest from our US clients. This service attracted considerable interest at the AAPS (American Association of Pharmaceutical Scientists) conference which we attended for the first time last Summer.
The US companies we spoke to are interested in using our analysis and Qualified Person (QP) services to certify batches of medicinal products prior to release for sale within the European Economic Area.
We were recently awarded an MIA (IMP) licence and this adds significant value to our portfolio of services. As well as our traditional core offerings of analysis and formulation development we can also provide small-scale production and have a QP available to release the product for use in clinical trials.
For overseas clients this service can shave valuable time from the development process and enable rapid development of the drug to reach the clinic in a more efficient manner.”
Our investment and hard work has paid off with our latest news: we have just gained a manufacturing licence following a successful UK MHRA GMP audit. We can now manufacture products for clinical trials, which is a huge step forwards for us.
We can offer clients the efficient option of allowing us to handle all stages of the development process from first analysis of an interesting molecule to manufacture of product for Phase I and II trials.
We’ve been an approved contract testing laboratory for some time, and this new manufacturing licence adds significant value to the services we’re already offering. As well as support for formulation development, analytical method development and validation and stability studies we can provide small scale production and batch release of product for use in clinical trials.
One of the reasons we’re so pleased to have made this step is that a ‘one-stop’ approach to early drug development will benefit clients who want to accelerate new product and device advances. Our analytical approach allows us to troubleshoot and address issues early on. This will provide a high degree of confidence in the final formulation. It will also benefit larger clients who need routine testing and a fast turnaround.
By offering analysis, formulation development and manufacture on one site, we can screen formulations in a cost and time effective manner to identify those most likely to succeed.
Once the product is ready to go to the clinic, with our new MIA (IMP) licence, we can manufacture the product and have Qualified Person (QP) available certify batches of medicinal products for use.
Read more in Business Weekly
The latest drugs create new challenges for our analysts and formulators as they tend have reduced solubility and stability. We’ve certainly enjoyed working alongside our biotech clients to address some of the issues. They are at the forefront of innovation which makes for exciting projects.
Some clients want a hands-on approach – they often work alongside our scientists in dedicated project rooms that protect their confidentiality. It’s valuable to discuss what’s required right from the start.
Before we launch into drug development it’s important to keep in mind what we’re trying to achieve. At the early stage you don’t necessarily need a perfect method, just one that is fit for purpose. This can save considerable time and expense.
One thing we know from the start is that biotechnology products will need to go to the regulators at some stage, and early-stage analysis can help create a data portfolio that adds value and provides confidence during licensing negotiations.
There’s a temptation for biotech companies to dismiss traditional techniques, but we often give the advice that these approaches are the best choice. Although we offer a range of analyses we often find that conventional techniques such as High Performance Liquid Chromatography (HPLC) produce all the information that’s needed. They have a broad range of applicability and are reliable even with smaller biomolecules.
Other facilities include a formulation suite with support for lab-scale manufacture, support for novel device development including inhalers and nebulisers, and extended stability storage and test rooms.
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Mark Hammond
Martin Westcott
Carol Barbour
David Ward
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