The discovery, development, approval, launch, and mass production of pharmaceuticals and biologics depends on high quality manufacturing. Yet many pharma companies treat it like a downstream concern during development.
Large and more mature companies are taking a strategic end-to-end approach to suit the criticality of successful toxicology studies, clinical trials, tech transfers, and commercialization. Here’s why.
Manufacturing is Deeply Embedded in Drug Development
Manufacturing underpins every stage of the pharma-bio lifecycle and represents many opportunities for efficiency gains.
- Early discovery and preclinical, such as initial synthesis, stability testing, and small-scale laboratory and manufacturing practices for toxicology studies.
- Development optimization, including synthesis and production methods, raw material selection and qualification, and analytics and product characterization.
- Clinical trials, which require GMP material, multiple-dose packaging and labeling, and possibly duplicate sourcing and/or complex supply chains.
- Tech transfers of processes and knowledge from R&D to pilot plant to commercial facility—both internal and to contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs).
- Supporting regulatory filings by providing data such as process validation and batch records.
- Launch readiness, ensuring the supply chain and manufacturing network can meet demand and manage logistics across markets.
- Ongoing lifecycle management, which may involve process changes, site expansion or addition, product line extensions, production improvements, or handling adverse events.
There are major opportunities for risk reduction and cost and time savings in every one of these activities.
Reduce Regulatory Risk
The FDA and other regulatory agencies scrutinize chemistry, manufacturing, and controls (CMC) data as much as clinical data. And they expect quality-by-design and risk-based approaches throughout the lifecycle, not just at the commercial stage. Investment in manufacturing systems, documentation, and quality control reduces the risk of queries early on and warning letters later.
Prepare Early to Scale
Tech transfer from R&D to clinical to commercial manufacturing can be a risky transition. Strategic planning and execution that include the R&D, clinical CMC, and commercial operations teams from the outset can prevent problems and lead to more seamless transfers.
Similarly, working together to proactively design scalable, cost-effective processes and develop supply chain relationships can reduce cost of goods and improve long-term margins.
Time-to-Market Advantage
Manufacturing issues are a leading cause of delays in launch timelines. So a strategic approach that begins during process development and clinical manufacturing can accelerate regulatory approval and market entry. Robust cross-functional project management with all stakeholders—technical, operations, and business—can help minimize risks and cost and realize time savings.
As a bonus, an integrated strategy can help assure potential investors and partners—even your own C-suite—of your commercial readiness and maturity.
It also can make you more attractive to CMO and CDMO partners, who can get up to speed quickly at any stage of the lifecycle and scale capacity up and down as necessary. It pays to build strategic relationships with these vendors. They are in high demand, especially as U.S. pharma companies consider them an alternative or temporary solution to reshoring manufacturing.
Change Your Mindset About Manufacturing in Drug Development
Manufacturing is a strategic enabler of drug-development success, rather than just a logistical function. Companies that embed manufacturing quality and scalability throughout the pipeline are better positioned for timely approvals, better compliance, lower risk, lower costs, and stronger commercial success.
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