This post lays out qualifying factors for choosing a biotech contract manufacturer, with a notable argument in favor of dedicated contract-manufacturing specialists over product companies selling excess capacity.
Key factors
- Quality and regulatory match — not just for today’s requirements but future ones, given the increasingly stringent regulatory environment
- A dedicated services company argument — a product company with excess capacity for hire is not the same as a company whose sole business is contract manufacturing; the latter offers better assurance and avoids competing with its own clients
- Technical strength, operational excellence, and supply chain execution as core evaluation dimensions
- Demonstrated accountability and agility — evidence the manufacturer brings solutions when things don’t go as planned
Choosing the right biotech contract manufacturer to partner with is critical for your business success.
Get it right, and a good contract manufacturer relationship gives you superior supply chain leverage. Choose the wrong contract manufacturer and you risk delays and cost overruns.
The path to finding and engaging a knowledgeable and dependable contract manufacturer is having a well-defined set of parameters. Defining these factors before qualifying potential contractors will help you arrive at an objective conclusion.
Key factors to consider in qualifying and choosing the right biotech contract manufacturer:
- Do they match your Quality and Regulatory requirements? Not only for today, but in the future?
The increasing regulatory environments in this market are here to stay.
- Are you enabling a future competitor?
A product company with excess capacity for hire is not a contract manufacturing services company.
- Is your intellectual property safe?
A services company dedicated to contract manufacturing is the best assurance you have. There is a reason the entire contract manufacturing industry (over $300 Billion in annual sales) operates this way.
- What expertise does the manufacturer have?
Consider technical strength, operational excellence and supply chain execution.
- Is there transparency in pricing and costs?
These are essential for a healthy, long-term relationship for both the client and the contract manufacturer.
- Are there demonstrated examples of accountability and agility from the contract manufacturer?
Not everything in a relationship goes as planned and a good contract manufacturer will bring solutions to the table to deal with unforeseen circumstances.
Now more than ever, the Life Sciences industry is moving and maturing at an accelerated rate. The changing regulatory environment, focus on innovation and new products, combined with increasing cost and pricing pressures provide an opportune time to upgrade your operational arsenal. Follow these key factors when choosing and qualifying the right biotech contract manufacturer, and you will add a trusted CDMO partner that can transform your company’s global supply chain into a competitive differentiator.
Click to download the full case study: “Contract Manufacturing in Biotech: Turning Your Supply Chain into a Competitive Differentiator”
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