Selecting the right contract development and manufacturing organization (CDMO) is the difference between a product launch running on schedule and a costly nine-month delay. Tech transfer timelines often extend beyond initial projections. A process scheduled for four months can stretch to nine, with validation challenges and timeline adjustments becoming necessary along the way.
Pharmaceutical companies evaluating CDMO partnerships need to ask the right questions to reveal whether a manufacturing partner has demonstrated capability backed by a verifiable track record.
What should you ask a CDMO before signing a contract? Here are eight questions focusing on measurable factors that impact timeline, quality, and commercial success.
“Can you handle our commercial volume?”
“Absolutely,” your prospective CDMO confirms.
But six months into production, they begin conversations about splitting manufacturing across multiple facilities. Quality protocols now require dual validation processes. Supply chain coordination becomes more complex.
This creates new challenges: Quality protocols now require dual validation processes. Supply chain coordination becomes more complex with inter-site logistics management. Why does single-site manufacturing matter? Multi-site manufacturing introduces operational complexity that extends project timelines and creates ongoing supply chain dependencies.
What are the advantages of single-site manufacturing?
Lannett’s complete 400,000 square foot operation—compounding, manufacturing, packaging, quality control, regulatory affairs, and warehousing—operates from one integrated 30-acre (12.4 hectare) campus in Seymour, Indiana. This has measurable benefits:
Will my product be manufactured, tested, and packaged at a single location, or will it move between sites during production?
How long does pharmaceutical tech transfer actually take?
Tech Transfer can range from as little as 4months up to 24 months, depending on the complexity of the transfer.
This is why verifying your potential CDMO’s tech transfer track record—with numbers—is crucial. The difference lies in the accuracy of process characterization and the thoroughness of preliminary assessment.
Why do tech transfers fail? Because process documentation can capture procedural steps but doesn’t always capture the operational knowledge that ensures reproducibility. In other words, it captures what you did, but not always why it worked.
Critical process parameters (CPPs) often reside in undocumented operational expertise, such as specific visual cues, environmental factors, and subtle equipment behaviors that experienced operators recognize and adjust for.
There are three elements we’ve discovered that lead to successful tech transfer:
– Will you conduct pilot runs before GMP manufacturing?
– What’s your first-pass success rate for tech transfer?
What’s the difference between regulatory compliance and regulatory expertise?
Every legitimate CDMO maintains compliance. Fewer demonstrate expertise.
Compliance means meeting minimum FDA requirements.
Expertise means anticipating agency questions, structuring submissions strategically, and maintaining working relationships that facilitate efficient approval pathways.
How do you verify a CDMO’s regulatory track record? Here’s what to ask for:
All legitimate CDMOs maintain FDA compliance through current Good Manufacturing Practices (cGMP) adherence and regular inspections.
– What’s Your FDA Inspection History?
– Show me your last three FDA inspection reports. What observations did you receive, and what was your remediation timeline?
Can all CDMOs manufacture high-potency compounds? The short answer is no.
Most CDMOs lack the specialized infrastructure that high-potency manufacturing requires, including dedicated containment suites, specialized HVAC systems with validated monitoring, and trained personnel, which is all infrastructure that cannot be easily retrofitted or improvised.
Lannett CDMO has specialized capabilities to handle diverse compound classes across the complete OEL spectrum:
What can you do to find out your potential CDMO’s high-potency and complex compound manufacturing capabilities?
– Can you handle high-potency or controlled substances?
– What’s the lowest OEL you’ve successfully manufactured? Can I tour your containment facilities?
Why do CDMOs accept projects they later struggle to execute? Business development teams are often evaluated on contracts signed, while technical teams become involved too late to provide realistic capability assessment.
This sequencing creates risk when commercial teams commit to timelines without validation from manufacturing, analytical, or formulation specialists who understand equipment limitations and process complexity.
Beyond basic GMP compliance, pharmaceutical development requires specific technical capabilities that you should verify upfront, such as:
Lannett’s technical manufacturing capabilities include:
It is crucial to evaluate whether your CDMO understands the importance of early technical team involvement and comprehensive project management.
– Who on your technical team will review our process before we proceed with contracting? Can I speak with them during evaluation?
Current capacity utilization indicates immediate availability, but long-term partnership viability requires understanding expansion capability and capital investment plans.
CDMOs operating above 85-90% utilization typically cannot accommodate volume increases without capital expenditure or production line additions, which often require 12-18 months, at minimum.
Understanding current capacity utilization and growth accommodation capabilities provides insight into a partner’s ability to support your volume increases without compromising schedule commitments.
Warning signs that suggest capacity availability constraints:
Lannett CDMO maintains an annual production capacity of 3.5 billion oral solid dosage doses and 2.0 million liters of liquid formulations, and we can scale production by 10x or more on current equipment and facility capacity.
Our demonstrated record of schedule attainment reflects effective capacity management that balances multiple customer requirements without over-commitment.
If you plan to scale commercially, it’s critical that you know your CDMO company’s current utilization and growth capacity.
– What percentage of your total manufacturing capacity is currently utilized?
– How far in advance are production slots typically scheduled?
Should you choose a US-based CDMO? The economic calculations that influence manufacturing location decisions have shifted significantly in the current regulatory and trade environment.
Pharmaceutical manufacturing cost structures have shifted significantly in the past 24 months.
Historical cost advantages for offshore manufacturing (typically 25-35% lower production costs) now require recalculation when factoring in tariff exposure, extended supply chains, and regulatory coordination complexity.
What’s the real cost of offshore manufacturing now?
What advantages do US-based CDMOs offer? These include:
Lannett CDMO’s single site in Seymour, Indiana operates without offshore supply chain dependencies, where we:
Given the total cost calculation variables between domestic vs international manufacturing and the increasingly strategic benefits of U.S.-based CDMO partnerships, you need to account for factors that affect your CDMO’s overall value proposition.
– How are trade tariffs affecting your costs?
– What percentage of your supply chain is exposed to international tariffs or geopolitical disruption risk (from raw materials through finished product)?
Why does data integrity matter for pharmaceutical manufacturing?
Paper-based systems and manual data entry introduce three categories of risk that affect both regulatory compliance and operational performance:
What should a modern CDMO’s data systems include?
Throughout our 75-year history, Lannett CDMO has continuously invested in digital infrastructure, manufacturing and quality systems.
From validated GxP systems across all manufacturing and quality operations, to electronic logbooks and comprehensive LIMS including Chromeleon for chromatography data and Master Control for quality management, we utilize automation for batch record accuracy, eliminating transcription errors inherent in paper systems.
We also maintain real-time quality monitoring that enables immediate response to process variations.
– Are your batch records electronic or paper-based?
– Can you demonstrate your audit trail system and data integrity controls?
The difference between a successful partnership and a costly mistake often comes down to asking the right questions early.
Before signing with any CDMO, verify these capabilities through documentation, facility tours, and technical team consultations:
Smart evaluation starts with the right questions. Smart partnerships start with straight answers.
You’ve read the eight questions. Now get eight straight answers.
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