Melbourn Scientific undergo major expansion plans

By Wai Lang Chu

- Last updated on GMT

Related tags Project management

Melbourn Scientific, report an eventful month in which the
expansion of its range of services has resulted in the purchase of
new premises, as well as meeting requirements of good manufacturing
practice that regulate the manufacture and testing of
investigational medicinal products.

The contact analytical service provider has extended the range of pharmacopoeial testing that it offers following interest from customers.

Pharmacopoeial testing requires specialist skills. It is taught at few universities because it requires expensive reagents and an investment in specialist glassware and other equipment. It is rarely economical for companies to retain people with these skills for the few occasions when the tests are needed.

Melbourn Scientific is expanding its pharmacopoeial test facility investing in the equipment and reagents required to run the full range of tests such as: Organic Volatile Impurities (OVI's), Kjeldahl nitrogen determination, sulphated ash, optical rotation and refractive index determinations.

"A number of clients had requested Pharmacopoeial testing and we made an investment to support this, the natural progression was to build on this and offer a complete range of tests,"​ said managing director Steve Westcott.

"Response from clients has been enthusiastic and the staff are keen to take on the challenge."

Another service that the company have recently introduced is the on-line service offering up-to-the-minute details on the status of their respective projects.

On-Track, the scheme by the Cambridge-based company allows the access of information on details of their projects including samples in stability storage, dates for sample analysis and project status and projected report dates.

The idea behind this service stems from observations that clients are not always in a position to constantly be informed on the status of their projects.

"Many of our clients are global, and can be based in different time zones or constantly travelling,"​ said Mark Hammond, business development manager for >Melbourn Scientific.

"Our service recognises that they often require information on the status of their projects at any time. It also offers them to chance to stay informed on a day-to-day basis."

The scheme is suitable for clients involved in stability trials often lasting three to five years. Using On-Track, they will be able to pinpoint exact dates for forthcoming analysis of products such as tablets, inhalers, creams and capsules.

In addition, the service will provide them with a flow of information - regularly updated by project managers - that can be easily tailored for management reports, if necessary minutes before a meeting is due to take place.

"Many of our clients will also have contract or outsourcing managers overseeing several different projects at once,"​ said Hammond. "On-Track offers them convenience and openness, plus the reassurance of knowing they can keep a watching brief."

And finally Melbourn report it has become one of the first analytical laboratories in the UK to be inspected for GMP under the EU Clinical Trials Directive.

These inspections, carried out by the Medicines and Healthcare products Regulatory Agency (MHRA) differ from those of the FDA as they focus on the quality control within the laboratory and are not restricted to a single project or product.

Therefore the investigation was far reaching, ranging from the management of the organisation and training of staff right down to the way that samples are logged and stored.

Good manufacturing practice (GMP) ensures that a medicinal product is fit for purpose ie it is the right product, right strength, free from contamination and has not deteriorated or degraded in any way - all procedures carried out by an analytical laboratory.

Melbourn, which has already passed four inspections by the FDA, underwent the MHRA inspection that many believe is the most meticulous and scrutinising out of the various assessments.

"In order to demonstrate that its systems and procedures are rigorous, labs are asked to analyse samples from diverse sources using methods that could be new to the analysts involved,"​ said Hammond.

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