Developing new drugs requires expertise, sweat equity and maybe even a bit of luck. Clinical researchers who reach the point where they consider starting their own pharmaceutical firm might think they’ve completed the hardest part of their journey.
But these researchers would be wrong.
Going from university lab to pharmaceutical manufacturing with multi-country sourcing and distribution is a massive undertaking, one that requires different tools and skill sets than what was needed for a university lab.
The challenges that labs typically face when they scale to a multi-country sourcing and distribution model typically revolve around four areas: Ramping up manufacturing to meet commercial requirements, securing proper funding, protecting intellectual property, and managing regulatory compliance.
Let’s take a quick look at each of the four.
- Meeting Commercial Manufacturing Requirements
Early stage development is often performed with small-scale batch synthesis. When a lab starts to transform into a pharmaceutical manufacturing operation, however, new issues emerge such as obtaining raw materials and identifying the right manufacturing partners to meet demand at scale.
Making the leap from university lab to commercial production environment is no small feat. Production facilities need to satisfy requirements for timeliness, cost- regulatory compliance, cost-effectiveness, and geographical proximity.
Sourcing raw materials and working with suppliers and distributors requires new processes, personnel and systems such as ERP software for tracking the manufacturing and distribution process.
- Securing Proper Funding
The second challenge is finding the funding to make the jump from university lab full-fledged pharmaceutical company.
Some of the funding options include venture capital (VC) groups, a pool of angel investors, and grant opportunities such as a Small Business Innovation Research grant or other governmental program. Figuring out the right grant options, and getting in front of the right people for VC or angel investments, is key to making the transition.
Pay particular attention to external vendors and partners with existing relationships to funding organizations when starting your firm.
- Protecting Intellectual Property
Defending intellectual property (IP) is the third bump for many labs that are scaling up to start their own manufacturing; there’s both the need to avoid patent infringement and properly protect the IP that sits at the foundation of your company.
All IP should be cross-referenced against existing patents and protected during the transfer over to the new company. This is commonly performed by an internal legal team or contracted outside law firm, but gaps might also need to be addressed by further lab work to properly build the IP.
A new pharmaceutical manufacturer might need to prepare additional patent example compounds or perform analytical measurements for confirmation of substance differences, for instance.
New pharmaceutical manufacturers need to perform this work quickly and make sure they take advantage of their IP during its limited patent life.
- Managing Regulatory Compliance
Finally, a fourth challenge that labs often face when scaling is handling the added regulations that come with being a pharmaceutical manufacturer.
Drugs must adhere to the FDA’s current Good Manufacturing Practices (cGMP) of the FDA, for instance. The cGMP requires that all commercially-produced drugs meet strict assay, quality and purity requirements. Facilities must have appropriate quality management systems in place to detect, investigate and correct product variations and detect the root cause of these variations.
The new regulatory hurdles are perhaps the trickiest part of making the leap for a lab; they require trace and tracking along the entire manufacturing process, as well as the need for the creation of an audit trail to prove that the pharmaceutical manufacturer is monitoring and correcting for variations and adhering to regulations (again, this is where ERP comes into the picture for the pharmaceutical manufacturer).
There is a range of new issues and systems that must be put in place to make the leap from university lab to manufacturer. Developing a new drug is just the start.
While we can’t help with the funding or intellectual property challenges, we can help your lab meet the commercial manufacturing requirements and manage the regulatory hoops. Our customized SAP solution for pharmaceutical manufacturers is a cloud-based, turn-key ERP system for labs that are ready to go to market or are seeking FDA approval.
If you’re thinking about expanding beyond the lab to become a Life Sciences manufacturer, contact us
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