Melbourn Scientific

Services

Melbourn Scientific provide contract analytical and formulation services for the pharmaceutical, biopharmaceutical, biotechnology and healthcare industries.

Our experienced team of analysts and formulators offer a wide range of support including formulation and product development, analytical method development, method validation, method transfer, stability studies and pharmacopoeial/QC release testing on pharmaceutical products.

In addition to our many years of experience working with traditional formulation types, we also have significant experience of more novel and complex delivery systems including inhaled and intranasal products and transdermal devices.

Services include:

• Analytical method development
• Validation of analytical procedures
• Accelerated Feasibility Studies
• Stability study design, storage and testing
• Lab/clinical scale formulation services
• Pre-formulation and excipient compatibility screening
• Cleaning validation
• Residual solvent testing
• Sub visible particulates
• Laser particle sizing
• Pharmacopoeial testing to BP, USP, JP and Ph.Eur.
• Batch release and raw material testing

The Melbourn Scientific facility is cGMP compliant and is regularly inspected by the FDA and the UK MHRA.

Melbourn Scientific’s open plan laboratory is ergonomically designed. The laboratories have been ergonomically designed to include large open plan work areas with multi-function workstations providing the functionality and flexibility required in a contract laboratory. With the ability to tailor specific labs and dedicate equipment to client requirements, we are able to meet your most stringent project requirements in a timely and efficient manner.

With dedicated areas for services such as HPLC and dissolution testing, multiple temperature and humidity controlled environments for inhalation testing, plus additional space to expand capacity and resource to meet client demand, the Melbourn Scientific facilities are guaranteed to provide solutions for your projects.

Method Development

Melbourn Scientific provides method development to ICH guidelines.

To ensure successful method development there is a requirement for highly skilled analytical judgement. Ideally the method development exercise should start with a ‘clean sheet of paper to allow information to be gathered that is uncluttered by past events. However if there is relevant history to the development project then this will be taken into account.

The ‘purpose’ of the method needs to be determined with some clarity and thoroughness as this will ultimately determine the long-term success of the new method. Other aspects of information and those that relate to the actual analyte in question and the ‘other’ materials that may be present in the analytical mix. The strategy for the method development process will result from this initial information gathering exercise.

The result of this review is an objective outcome that ensures the developed method will be as ‘fit for purpose’ as possible, given that the requirements of the method have been sufficiently well defined. However, methods are adapted for similar situations and made to fit other challenges that come along during the development process. With our wealth of experience in this area we can discuss with our client the development strategy to allow the method to be developed for as wide a range of application as possible together with as simple, rugged method as we can obtain.

Method Validation

There are various stages in the life of an analytical method from early stage development to the monitoring of final product. It may take several years to get this far and it is unlikely that the method will survive unscathed even if the product does.

At each stage the requirements of the method and the validation that is required varies. When those changes occur and when it is appropriate to move to the next stage of validation is not an exact science.

The regulatory bodies, and in particular the FDA, have provided a unifying approach to acceptable standards which has enabled all companies working within the auspices of Good Practices to speak the same language and be universally understood.

However, this area is still one that is poorly understood despite excellent guidance documents. So working with an experienced partner that has a good working knowledge of the standards and a pragmatic approach to method validation can be enormously beneficial.

*Accelerated Feasibility Services

Accelerated feasibility*

Accelerated feasibility projects are designed to expose any weaknesses in the formulation at an early stage. The idea is to anticipate the weak spots and set up challenges to eliminate them. Close cooperation between formulators and analysts speeds up this process.

Specialist equipment, such as that designed for ultra high performance liquid chromatography (UPLC) increases productivity by streamlining workflows and processes.

Recent acquisitions include the latest Waters UPLC technology which, with its high throughput and low run times, enables many analysts to work simultaneously on a project allowing teams to reduce turnaround of projects to days rather than weeks.

Stability Storage and Testing

A particular strength of Melbourn Scientific is the design and implementation of stability studies, with over 20,000 litres of ICH storage capacity and over 20 years experience in stability study management.

Stability studies are designed to provide evidence on how the quality of drug product will vary when it is exposed to a variety of environmental factors such as temperature, humidity and light at various stages of a product lifetime.

Data generated helps to establish either a retest period for a drug substance, or a shelf life and recommended storage conditions for a manufactured product, and are thus essential to minimise market risk.

As real time data are required, these studies can be on project critical paths so any delays will adversely affect submission dates. For these reasons the active involvement of an experienced partner can offer significant benefits.

Stability studies are ideally suited to outsourcing because they are:

• resource intensive with peaks and troughs of activity
• samples need to be stored securely over several years with intensive testing in the early stages
• a vital part of the documentation for any drug submission

Melbourn Scientific has specialist knowledge of stability studies:

• Stability testing is part of our core business
• A significant investment has been made in cabinets, controlled environment rooms and other specialist equipment for ICH and client defined conditions
• Capacity and long-term security for studies lasting 5 or more years

Stability Testing

Stability studies can be on project critical paths so any delays will adversely affect submission dates. The active involvement of an experienced partner can offer significant benefits and the trials are ideally suited to outsourcing:

Stability studies are resource intensive with peaks and troughs of activity. Samples need to be stored securely over several years with intensive testing in the early stages.

Melbourn are ideally placed to manage these studies and provide the accurate real time data that is required as part of the documentation for any drug submission.

QC Release Testing

Melbourn Scientific Limited offers a broad range of services to characterise the quality of raw materials, APIs and finished products, from early development through to quality control of marketed products.

With a range of techniques and technologies available we are able to transfer and work with client supplied methods, literature/pharmacopoeial methods or develop methods for your specific needs for release testing or one-off investigations.

Pharmacopoeial Testing

Pharmacopoeial testing is a requirement for many stages of product manufacture and there are fewer and fewer companies with the specialist skills needed to perform the tests. To meet demand from its clients, Melbourn Scientific offers an extended portfolio of pharmacopoeial testing to USP, EP and JP requirements.
All tests can be performed under GMP as required by the client.
Standard pharmacopoeial testing is carried out according to EP, USP and JP analytical methods for new and existing compounds can be developed and validated in line with specific guidelines.
Drug substances, excipients and pharmaceutical products are tested in accordance with pharmaceutical legislation, GMP and the requirements outlined by the ICH and pharmacopoeias.

Inhaled Product Testing

Melbourn Scientific has significant expertise in the analysis of inhaled, intranasal products and delivery devices. A specialist in providing support for device concept, product design, CMCstudies and regulatory submissions it invests continually in the latest equipment in this area.

The company has a highly experienced team able to provide guidance on the best approach for product performance testing as well as method development, validation and transfer support. State of the art facilities include programmable temperature and humidity controlled environments for all inhaled and intranasal analysis and utilises the latest test equipment for the following product types;

• Dry Powder Inhalers (DPIs)
• Pressurised Metered Dose Inhalers (pMDIs)
• Sub Lingual Sprays
• Nasal Sprays
• Nebulisers
• Other novel delivery systems

As one of Europe’s premier testing laboratories Melbourn Scientific can undertake the most challenging projects with significant resource for;

• ACI
• NGI
• MSLI DUSA & ED
• Malvern Spraytec
• TTP Electronic
• Copley Breath Simulator

Formulation Services

Melbourn Scientific offers design and optimisation of formulations for solids, semi-solids, inhaled, nasal and nebulised drug formulations. Working closely with our clients we are able to undertake pre-formulation compatibility work, formulation screening, lab scale formulation and accelerated feasibility studies to produce the desired characteristics and speed up project timelines.

Our in-house formulation team enables small amounts of products to be developed using experimental design methodologies supported by testing at every stage.

We have significant experience of developmental studies for the following delivery types

• Dry Powder Inhalers (DPIs)
• Pressurised Metered Dose Inhalers (pMDIs)
• Nasal Sprays
• Nebulisers
• Tablets (IR and SR)
• Capsules

Certificates
cGMP
MHRA
FDA
ICH