Outsourcing to a contract manufacturer these days means more than just having your product manufactured and drop-shipped. But what – exactly – are today’s pharma companies expecting from their manufacturing partner?
Global is Good – as Long as it Functions as if it’s Local
The interaction between pharma or biotech companies and contract manufacturing firms has evolved significantly over the last 20 years or so – becoming much more tightly-knit in the process. As firms interact globally, however, supply chains have grown increasingly complex.
Today’s global supply chain economy means manufacturing no longer needs to reside in-house…or locally….or even in the same hemisphere. Regardless of where elements of your supply chain are located, however, you want it to act like it’s in-house. That’s why life sciences firms are increasingly seeking out CMOs that can seamlessly integrate with them and provide the other invaluable services & support key to a drug candidate’s success.
Technology can deliver part of the solution, but a CMO needs to be able to build a project team environment that allows your business to be included as much – or as little – as you need. It is becoming more and more common to find CMOs who provide reps local to your business – and fully-connected to the overall project.
Intellectual Property Rights
In many ways, the lifeblood of the life science industry is intellectual property. Your company will likely invest millions (and even billions) of dollars into research that must be protected. Contract research and manufacturing tends to complicate the IP picture, given that the creation of the novel property may be happening elsewhere…outside your firm. An additional stumbling block for some life sciences firms: the contract manufacturer may also be a generics manufacture – creating a potential conflict of interest that must be addressed contractually.
A handful of CMOs –us at Neuland included – have begun choosing to not compete with our customers. We’ve found this strategy to be very successful. Customers know they will never be in a situation where they find themselves competing with their CMO – either in the drug development or generics space – and it allows us to focus solely on being our client’s research, development or manufacturing partner.
Standing between a drug candidate and market launch is an arduous and exacting regulatory approval process. Your company’s ability to navigate the regulatory landscape is only as strong as the support you receive from various partners and providers around the world. Because discovery, research, development, manufacturing and regulatory affairs all interact with one another, CMOs – especially firms which handle projects from early stages through market launch – should be streamlined for both efficiency and the flow of information.
Your pharma company needs to know that the CMO is capable of providing regulatory support over the course of the product lifecycle – including whatever regulatory hurdles the future may hold. Critical information cannot be kept in silos. For example, the Analytical Research function provides support to the Regulatory approval process with crucial inputs on genotoxic impurities and metallic content usually found in trace levels and detected through hyphenated techniques.
One of the most important features pharma companies are looking for in a manufacturer is their regulatory approach – it’s breadth and flexibility. Do they have the ability to function in virtually any regulatory market worldwide? Are they flexible, and capable of managing unique regulatory challenges?
Expertise & Follow-Up Support
Over the lifecycle of the product, issues tend to arise that demand assistance from – and interaction with – your contract manufacturer. It might be a change in procedure, an improved technique, a new regulatory standard or the need for an additional piece of documentation. Process development support must be aligned with the issues related to scale-up and transfer of technology. Building the right team with your CMO is critical. (Read this good article on the topic in this month’s Contract Pharma: The Human Elements of a Successful Relationship – outsourcing drug development)
Pharma companies want partners whose team members keep up with the latest in manufacturing technologies and regulatory matters and stay engaged. Across the spectrum – from discovery through manufacturing – you need to be able to rely on your manufacturing partner to keep abreast of industry matters – especially things that directly relate to your product.
The Future Brings Further Integration…and More Information
Pharma companies know what they need in a partner today, but what will they demand from contract manufacturers tomorrow? One of the answers is data – more information, in real-time, available whenever and wherever it’s needed. Forward-thinking CMOs are already placing themselves one click away from their clients – generally through proprietary life sciences-focused project management systems. This trend towards electronic integration will continue for the foreseeable future as pharma companies demand even more data – faster – in an effort to speed up drug development and lower costs.
What concerns does your life sciences company have when outsourcing to a contract manufacturer? Comment here.