Many small drug discovery companies need to outsource the production of materials for clinical trials. Susan Birks visited Bodycote Prova, in Camberley, UK, whose recent expansion aims to tap into that niche
It is a long, complicated path for any new drug candidate from that "eureka!" moment of discovery to final packaging and to market. The path is beset with hurdles, not the least of which is the years of careful experimental analysis and clinical trials needed to ensure the drug is effective and safe.
Today, faced with rising costs and increased competition, the major pharma companies are forced to focus on core manufacturing technologies or market competencies, and to contract out many other aspects of drug production. As a result, it is estimated that spend on contract research organisations (CROs) now accounts for around US$13.5bn (Euro 10.1bn) - 22.5% of the annual pharmaceutical and biotechnology r&d budget expenditure of about $60bn (â"šÂ¬44.7bn).1
The money is being spent on outsourcing to specialist companies involved in the various different stages of drug development - including the early development stages.
Contract development company, Bodycote Prova aims to tap into that spend. For several years it has offered contract pharmaceutical development, including formulation, analytical and regulatory services. Now, as part of Bodycote Health Sciences Europe, it also enjoys the financial backing and expertise of a large multinational testing group.
Recently, the Camberley operation opened a new manufacturing and packaging facility purpose-built for clinical trial materials production. With these facilities, the company intends to specialise in the manufacture of investigational medicinal products for early stage clinical studies.
It is a service increasingly being taken up by both big and small pharma companies, and with the rise in biologicals, Bodycote finds itself serving many new clients from organisations such as bio-incubators, university spin-outs and small companies that have discovery chemistry but no other lab facilities.
The studies carried out by Bodycote Prova's staff - mainly ex-multinational pharmaceutical graduates, 10 with masters and three with doctorates - may not be as exciting as leading edge drug discovery, but are nevertheless essential to enable a drug to be useful to patients. Gill Clarke, development director responsible for formulation development, regulatory and clinical trials, explains: "As our clients come up with drug compounds we help support them with intermediates for the API production and then API itself.
"These will be used to release that drug substance and generate the stability data. Following on from that we develop the methods that support the formulated product and then do the appropriate level of validation to support a regulatory submission and ongoing testing."
The work does not finish there, as it needs to be followed by the regulatory stability testing, plus associated testing to support short-term compatibility studies.
Much of this work has to be carried out "up front", says Clarke, otherwise, should the testing be later found to have been carried out using a method deemed unsuitable, a great deal of time and effort will have been wasted - something drug companies cannot afford.
The studies require specific equipment and considerable analytical and validation experience. It is this specialism in analytical method development and validation that has helped Bodycote Prova. "Not many companies are as strong in analytical development," Clarke says, "and because a lot of molecules don't actually get beyond preliminary studies, many of the larger CRO/CMO companies are not interested in this kind of work."
The company aims to get into such studies as quickly as possible, using a formulation that is relatively simple compared with what might end up on the pharmacy shelf.
"For an oral product it may be a solution or suspension of a drug or a capsule. It is not often a tablet in the early stages - tableting usually comes later. If it needs to be a parenteral, we can produce either a solution in an ampoule or a vial.
"We have a freeze-drier so, if it is not very stable in solution, we can produce it as a freeze-dried cake that can be reconstituted at the bedside."
Work on the company's new cleanroom suites started in February 2008. The rooms, now complete, are designed for the production of non- sterile products, such as capsules, creams, ointments, gels, oral solutions and suspensions under cGMP.
The suites enable the company to produce quantities of materials up to about 10 kg or 10,000 units - ample for such early stage development where customers often want only around 100 units. The company also has the facilities to deliver trial materials packed and ready labelled.
Having now received its MHRA licence Bodycote Prova is already finding interest in its services but there is plenty of competition out there.
"Flexibility, quality of service and technical input has always helped us in getting repeat business," says Clarke. And as competitiveness increases and drug profits decrease, more and more clients are looking for confidence in the quality of the service. "Clients want to do the job once, and get it done right," says Clarke.
Formulation capabilities at the Camberley facility
Capsules (hard/soft)
Tablets (d.c. or granulation)
Ampoules
Vials
Sustained release
Blow-fill-seal
Creams
Ointments
Gels
Suspensions
Freeze-dried products
Patches
Services offered By Bodycote Prova
Pre-formulation services
Salt selection
Solubility studies
pH stability profiles
Excipient selection