When Success is in Doubt, Can You Farm It Out?

Your Stability Program is focused on protocols, samples, chambers, disaster planning, testing, data analysis and reports. Any one of these areas can be a lot to handle without professional assistance. That’s where having knowledge of Stability-related CDMOs becomes invaluable to Stabilitarians in overcoming exigencies in space, time, budget and experience. Read on to bolster your preparedness for the inevitable challenges that will come.

So, your Stability Program is underway and/or flourishing. You’re focused on protocols, samples, chambers, disaster planning, testing, data analysis and reports—Each one gobbling up resources. You may happily have those resources in place, but in many cases they are yet to make it to your budgets. A Stability CDMO may be the path forward in some or all of these categories you’re focused on. CDMOs provide the specialized equipment, storage capacity, and scientific and regulatory expertise that many drug developers lack in-house.

A recent report by Grandview Research points to the significant growth in the CDMO Stability Sample Storage arena which is representative for other CDMO categories as well.

Let’s put some definitions behind our acronyms: CDMO stands for Contract Development (&) Manufacturing Organization. “CDMO” has become an increasingly popular alternative to represent the terms CRO (contract research organization) and CMO (contract manufacturing organization). “Stability CDMOs” would be those which offer one or more of the stability functions mentioned in the opening paragraph. Not being one to waste an opportunity, our discussion will be expanded to include some suppliers of stability equipment and services who are not technically CDMOs.

While stability guidances such as those from the ICH and FDA do not mention Contract Development and Manufacturing Organizations by name, they establish the mandatory scientific and regulatory framework that CDMOs must follow when performing stability testing services for their clients. For example, under US 21 CFR § 200.10, the FDA views extramural contract facilities as an extension of the manufacturer’s own operations, with the manufacturer retaining ultimate responsibility for the facility’s methods, results, and their use. The FDA may disclose information from contract facility inspections that pertains to the manufacturer’s product compliance with the Federal Food, Drug, and Cosmetic Act, and accepting the contract work is considered authorization for such disclosure. The regulation also specifies that results from analytical method validation studies and control procedures are not considered trade secrets that a contracted facility can withhold from the manufacturer.

In their recent article Understanding FDA Registration and FEI Number Requirements for Contract Storage Facilities, Ken & Monica Edwards explore the circumstances under which a stability storage facility may require an FDA Establishment Identifier (FEI) number and highlights its importance for regulatory compliance, submission of required documentation, and successful navigation of FDA inspections. When considering a CDMO, whether for storage or other stability-related functions, it’s incumbent on the client to know the applicable regulations, whether regional, national or international that impact the CDMO’s ability to legally transact business with clients that must comply with GMP requirements.

The responsibility for meeting Stability-related guidelines ultimately rests with the drug product owner who often teams up with CDMOs for their specialized expertise and facilities.

A CDMO becomes not only a business associate, but a partner in regulatory compliance. While excellence in quality and output is the goal of successful CDMOs, the client always bears the regulatory responsibility for all data and outcomes achieved through the CDMO. A 483 issued to a CDMO has the potential to halt production or sales of the client’s product. While the client doesn’t perform the correction, they should avoid falling victim to CDMO deficiencies through diligence beforehand. This sets up the following series of best practices used to ensure that this paradigm achieves the required outcome, and may include on-going quality audits and reviews to catch any emerging difficulties.

A word of caution regarding the CDMO Marketing vs Capacity conundrum: Most CDMO’s have a sales (“Marketing”) group. The epitome of success for a sales representative is to land the most clients possible. They approach potential clients with an enthusiastic message: “You have a need for the great organization and services I represent. They can do what you need to have done at a high level of expertise and compliance”. What they promote may be 100% correct, but there is a factor that shouldn’t be overlooked: Let’s say the CDMO has 100 wonderful Analysts in the lab and dozens of amazing managers in the office. They can easily manage the first several clients engaged through the sales force, but the sales force may be so motivated that the load of the next 20 clients can cause chaos, back-ups and a higher failure rate. When speaking with a sales representative of a CDMO, you should also speak with a scheduler or manager of resources to be sure that the CDMO’s capacity will keep pace with the fruit of an inspired sales force.

The article The Key To Outsourcing Is Timing-lines, Not Timelines, by Louis Garguilo, Chief Editor, Outsourced Pharma is a great piece offering a unique bilateral view of the Client-CDMO paradigm by a scientist who has worked both sides of the contracts. Give it a read in the link below and consider subscribing to Outsourced Pharma. Some key quotes from the article:

…we might better think more about timing-lines rather than timelines when it comes to working with external partners.

Ensure you base your projections on realistic timing-lines of the components needed to complete tasks and projects; focus on communication; and stay empathetic to the position your partner is in.

When everything clicks around user requirements, goodness of fit and CDMO quality and capacity, a quality audit by the client is arranged. The quality audit with your QA auditing team should include your in-house Stability SME to spot potential stability-specific issues.

A Medical Product Quality Agreement is a crucial, legally binding document between a Sponsor and a Contract Development & Manufacturing Organization (CDMO) that defines each party’s roles, responsibilities, and quality expectations for ensuring Current Good Manufacturing Practice compliance and product quality throughout the product’s lifecycle, detailing responsibilities for shipping, storage, testing, deviations, recalls, and audits, and serving as a roadmap to avoid conflicts and meet regulatory requirements.

See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry to go deeper into the regulatory requirements for quality agreements.

These agreements define project specifics, roles, tasks, timelines, and deliverables, acting as a crucial roadmap for success between parties, ensuring clarity, managing expectations, and reducing disputes by detailing what needs doing (SOW) and how (WOW), encompassing objectives, scope, payment, acceptance criteria, and change management processes for successful project execution, notes Thomson Reuters.

Ensures shared understanding, manages expectations, reduces disputes, and provides a baseline for managing changes. A SOW is a formal, detailed document outlining project scope, objectives, tasks, deliverables, timelines, costs, and acceptance criteria, often used for hiring external contractors or defining client-provider work.

Key components include project introduction, objectives, detailed scope (in/out), work breakdown (tasks/milestones), deliverables, schedule, resource allocation, assumptions, and payment terms.

Reduces ambiguity, helps onboard new members, prevents gaps/overlaps in work, and ensures consistent operation as organizations scale up the processes, roles, and communication within a team or across teams, detailing how workflows, clarifies responsibilities, and sets expectations for collaboration. Key components include team processes, communication protocols, decision-making, role delineation, and workflows.

It’s important to determine when the client can get access to data as it progresses from instrument to document to review to possible investigation to approval to release. Many will want to access it early as if it was generated in their own shop, but such interventions can cause delays, inaccuracies and disputes.

While a majority of agreements involve a modest amount of raw data review as part of periodic audits, it is not unheard of that FDA inspectors have expected far more, including 100% review by the client. The rationale and justification for the amount of raw data review should be well documented at the start of a CDMO relationship.

A good relationship incorporates elements of knowledge, trust, transparency, communication, and promptness.

Some steps in achieving such a CDMO relationship include:

Appropriate staff and management implies a practical level of involvement without involving higher levels of management unnecessarily until predefined levels of need are met. That said, “copying in” a client’s multi-discipline Stability Review Committee (SRC) in predefined CDMO communications could ensure that no surprises linger undetected in any bureaucratic potholes. In this age of digitalization, well-run SRC’s move information and address requested evaluations in a matter of hours, not weeks.

Establishing a good relationship requires that the cast of everyday characters in a routine client/CDMO interaction should be on a first name basis and on each other’s speed-dial.

If your CDMO has a quality issue, follow a structured procedure: immediately define the problem, assess criticality (minor, major, critical) with SMEs, pause production if needed, activate your Quality Agreement for communication, conduct a thorough Root Cause Analysis (RCA) and implement CAPA (Corrective and Preventive Actions), and escalate based on risk to patients/product release. Key steps involve leveraging your pre-defined Quality/ SOW/WOW agreements for communication channels, data sharing, and roles, performing a robust RCA to prevent recurrence, and ensuring open, honest communication with the CDMO leadership and your internal teams.

Returning to the Outsourced Pharma article by Louis Garguilo, we find some additional key advice regarding the Client/CDMO relationship:

Instead of dictating, we should ask ourselves: ‘Have we thought enough about what the CDMO is suggesting? Could we try it that way?’ “Small changes in attitude build mutual sponsor-provider commitment.”Along with attitude, communication of (those realistic demands) is vital. “I’ve learned to over-communicate — but with empathy,” “I acknowledge the pressure we are putting on our CDMOs, and I try to frame my questions in a way that shows respect for their expertise.”

Instead of dictating, we should ask ourselves: ‘Have we thought enough about what the CDMO is suggesting? Could we try it that way?’ “Small changes in attitude build mutual sponsor-provider commitment.”

Along with attitude, communication of (those realistic demands) is vital. “I’ve learned to over-communicate — but with empathy,” “I acknowledge the pressure we are putting on our CDMOs, and I try to frame my questions in a way that shows respect for their expertise.”

Through successes, trials and tribulations. Powell insists his strongest sentiment is that outsourcing is ultimately about humans dealing with humans.

“The data and equipment matter; the relationship can matter more,” “Sponsors who treat CDMOs with empathy, respect, and curiosity, get better results.”

Here are some examples of various Stability CDMO types and what each would like their potential clients to know about ensuring a successful partnership for their specific area of expertise:

CDMO Services: ICH and custom storage conditions, Vaccine and Biotech storage; Photostability; Thermal Cycling, Custom storage for back-up / overflow samples; Disaster Plan contingency space

What are the questions/makings of a good CDMO Sample Storage partner?

“Proactive planning and robust systems separate a strong storage partner from a risky one. When evaluating a stability storage partner, think beyond physical space. The real value lies in compliance, traceability, contingency planning, and digital oversight, all critical to avoid missed pulls or audit gaps.”

To ensure a seamless partnership and avoid common pitfalls, here are five key questions to discuss with your stability storage CDMO and why they matter.

1. Do you require storage for a few samples or an entire batch? What conditions will be necessary for your study?A capable provider should manage everything from a few samples to full batches, while accommodating standard ICH conditions and more complex or unusual requirements. Beyond the basics, look for a provider with a digital inventory system containing real‑time alerts that tie it all together and robust back-up systems, so timelines stay on track, and compliance risks are minimized. In short, a top‑tier storage CDMO doesn’t just store samples; they engineer reliability into every step of the process.
2. Are there any special handling requirements (e.g., controlled substances, hazardous materials, etc.)?These impact compliance protocols and storage conditions. Sharing this upfront avoids delays and ensures regulatory requirements are met from day one.
3. Do you anticipate overflow or back-up storage needs during peak periods?This question goes beyond logistics; it’s about risk management and continuity. Planning for surge capacity prevents last-minute scrambling and protects study timelines. A good storage partner will help you forecast these scenarios and build contingency into your storage strategy.
4. Can you share your game plan as to # of batches, samples, conditions and timing?As Aideen Glynn, Quality Manager at Q1 Scientific explains: “Your game plan matters. The foundation of a strong storage partnership is a clear, proactive plan. Tell us about batch numbers, sample counts, conditions, and timing upfront. This allows us to translate protocol timepoints into a precise schedule and align labeling and barcoding for full traceability.If you’re not sure of your game plan yet, then that’s okay too. Beyond storage, we advise on pull schedules, set-down dates, end-of-shelf-life and end-of-study testing, ensure access to retain samples for investigation, and even what actions to take if there’s a failure.

   Leading storage CDMOs factor in justified overages, chain-of-custody controls, and disaster recovery space. These steps prevent common pitfalls such as missed pulls or incomplete audit trails, while ensuring every sample remains compliant and accounted for.”

5. How will you transport samples to and from the storage facility?“Transportation is often the weakest link in the chain of custody,” “Ask about validated shipping processes, temperature-controlled logistics, and real-time monitoring during transit. A reliable CDMO should provide documented procedures for secure handling, contingency plans for delays, and full traceability from collection to arrival. This ensures your samples remain compliant and protected throughout the journey, not just while in storage.”

CDMO Services: Method Development; Analytical testing; Microbiological Testing

What are the questions/makings of a good CDMO Sample Testing partner?

CDMO Services: Component Characterization/Optimization; Packaging Characterization/Optimization; Storage recommendations

What are the questions/makings of a good iso-conversion CDMO Partner?

CDMO Services: Statistical Analysis Packages; Registration Applications; Regulatory Reports

What are the questions/makings of a good data analysis and reports CDMO partner?

CDMO Services: Preventive regulatory services, remediation for stability-related 483’s and Warning Letters, Registration guidance for stability data and report submissions

What are the questions/makings of a good regulatory remediation CDMO partner?

It seems likely that all Stabilitarians will have a stability CDMO in their future, even if just exploratory. It’s prudent to prepare for such an eventuality, following the basics of establishing this type of relationship.

ICH Q1 Draft Guideline Marks a New Era for Stability Testing. Published on: September 7, 2025. Aideen Glynn, Quality Manager at Q1 Scientific – a Cambrex Company.

Webinar – ICH Q1 Testing of Drug Substances and Drug Products. Published on: September 25, 2025.