“Drug companies are looking into CROs/ Lab that will service the analytical needs in rapid and accurate manner”
– Ranil Fernando, Vice President (Operations), BioScreen Testing Services
 |
| Sarabjeet Singh Sharad |
Early 1990 there were only limited contract research organisations (CROs) committed to serving the pharmaceutical industry. Several of the laboratories commenced either during or after the environmental ‘boom’ of the 1970s linked predominantly to environmental testing. Due to the decline in government capital of environmental monitoring, these laboratories started looking for new markets and customers. With the fast expanding LC/ MS technology, from the early to mid-1990s new CROs began to emerge which focussed in pharma analytical testing, predominantly for clinical and other biological samples.
These CROs/ laboratories have increased in number and some have expanded to sizes which rival the innovator pharma industries. Today, for e.g., Covance, Wuxi App Tec. CROs/ Lab etc have strategic “preferred vendor partnerships” with large and small pharma companies expanding to multinational sites globally. Several of these supposed “boutique” laboratories, with specialities ranging such as extractable/ leachable testing, inorganic analysis, and analysis of clinical/biological samples by LC/MS, have made strategic partnerships in analytical development.
Why are pharma companies looking for outsourcing to preferred vendors?
Drug companies nowadays consider outsourcing analytical development as a business model, an operation tactic rather than ad hoc service for additional analytical assignment. Many pharma companies are employing strategic partnerships with/ boutique providers by establishing preferred vendor relationships that can deliver a broad range of pharma development services, including analytical testing. Drug companies are continuing to look for long terms allies who will ensure expert staff and also comply with global quality standards for analytical development.
What are the benefits of outsourcing analytical service?
In-house laboratory functions are characterised by relatively high fixed costs capital investment and associated benefits and salaries. Assets and manpower are usually under-utilised in the in-house laboratories. Outsourcing will eliminate the rising lab costs and under-utilisation rates as well as reduce or rationalise the operation.
Innovator drug companies have now started to organise better internally for outsourcing, mostly with committed outsourcing groups. Drug companies have recognised that commoditised testing services like “routine testing” need to be outsourced as it will mainly include dosage form stability testing, release testing, and analysis of clinical and biological samples.
| Analytical development annual spending ($ millions) | ||
| Bio/ Pharma In-house | CDMO In-house | Contract Lab/ CDMO lab only |
| 190 | 164 | 664 |
| Note: Annual spending on analytical development and testing for small molecule drug product Source: Primary Expert |
||
What will be the major outsourcing change in the analytical landscape?
A lot of companies are demanding biologics support testing, such as RNA sequencing, gene expression analysis, micro RNA profiling and multiplex protein profiling.
Companies with the experience and platforms to deliver these services will continue to realise growth in analytical development. In the near future, companies with cluster computing tools and bioinformatics data analysis capabilities will be more desired as these speciality technologies that are emerging in the biologics testing space will continue to add value to drug innovators.
| Global spending on analytical development and testing for large-molecule drug substances by analytical activity ($ millions) | |||||
| Batch Release | Stability | Methods | Viral Clearance | Microbiology | Characterisation |
| 103 | 84 | 134 | 98 | 11 | 221 |
| Companies and investigators in diverse regions are gradually adhering to global regulatory standards, which will create additional growth through offshore providers of analytical testing. Source: Pharmaceutical Product Development |
|||||
What are the analytical development initiatives undertaken by preferred vendors?
Recently, there has been implementation of totally validated “Laboratory Information and Management Systems” that permit CROs/lab suppliers to enter the results straight into client data handling systems, along with consistent data attainment. This application softwares’ functions make outsourcing both an efficient and attractive proposition for future analytical development.
Analytical service providers have improved regulatory compliance to cGMP and cGLP procedures and maintain the essential certified standards for analytical development.
The upsurge in proportions of CROs, has led to increased competition for analytical development services, therefore the service providers have now started positioning themselves as one-stop shop for the full range of analytical testing facilities required for the drug companies.
Some of these service providers and their initiatives are:-
PPD, one of the prominent global contract research organisations, have recently extended their presence in Europe for analytical testing services
Catalentpharma has stretched its geographical reach with the opening of their European Development and Clinical Services Laboratory in UK
Wuxi App Tec has recently opened the largest “Toxicology testing Centre of Excellence in Suzhou which will provide safety testing and related services for drug development
Charles River is providing analytical services for vaccines as drug companies are concentrating across the development process in vaccine.
Conclusion
Over the next five years there will strong growth in the preferred vendor partnership model where mutual interest in continuous analytical improvement will lead to cost and time benefits that can be shared between the sponsor and vendor as a tool to manage R&D effectively. North America and Europe will lead this preferred partnership for analytical development due to well-developed infrastructure while in Asia it would be mainly due to low operational costs and rising talent pool of skilled analytical professionals.
The author can be contacted at [email protected]
