Cobalt Research BV

03/08/2025

"Precision Under Pressure: Validating Methods for Stress Conditions"
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When analytical methods are developed to support pharmaceutical products, validating them under stress conditions isn’t just a regulatory requirement — it’s a reliability guarantee.
Here’s what we assess to ensure your method performs, even under chemical or environmental pressure:
🔹 Specificity
Can the method clearly distinguish between the active ingredient and any degradation products or impurities?
🔹 Accuracy
Are the results consistent with the true value — even when the sample is under stress?
🔹 Robustness
Do small, intentional changes in method parameters (like temperature, flow rate, or pH) still yield reliable data?
🔹 Precision
Can we reproduce the results across multiple analysts, instruments, and days — without significant variation?
🔹 Detection Limit (LOD)
What is the lowest amount of substance that can be reliably detected — even in degraded or diluted samples?
🔹 Quantitation Limit (LOQ)
What’s the lowest amount that can be quantified with accuracy and precision?
🔹 Linearity
Does the method produce results directly proportional to concentration across the intended range?
🔹 Range
Over what concentration interval does the method remain accurate, precise, and linear?
🔹 Stability of Solution
Does the analytical solution remain stable throughout the testing period — or does degradation introduce error?
At Cobalt Research, we validate for performance, not just for compliance — ensuring your method holds up under pressure and stands up to regulatory scrutiny.

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02/08/2025

💡 Formulation Transfer Pitfalls: How to Avoid Batch Failure
Transferring a formulation from R&D to manufacturing isn't just a handover—it's a high-risk phase where small missteps can cause batch failure, regulatory delays, or even product recalls. Here's how to avoid the most common traps:

🔹 Inadequate process documentation
Missing or vague details in the tech transfer dossier can lead to inconsistent process ex*****on. Every parameter must be defined, justified, and aligned with scale-up requirements.

🔹 Lack of raw material equivalency testing
Assuming supplier-grade excipients behave the same as lab-grade can be a costly mistake. Compatibility, impurity profiles, and performance must be re-evaluated.

🔹 Ignoring equipment differences
Changes in mixing speed, shear, or heating profiles between R&D and production lines can impact the final product’s quality. Bridging studies and process adjustments are essential.

🔹 Limited cross-functional involvement
Successful transfers require early collaboration between formulation, QC, manufacturing, and regulatory teams to foresee and solve integration issues.

✔️ Planning ahead and validating assumptions early can save months in rework and approvals.

📌 Want smoother tech transfers with fewer surprises? We help clients mitigate risks before the first batch even starts.

30/07/2025

🔍 Preformulation Studies: What They Reveal About Your API Early On?

Before formulation even begins, pre-formulation studies give you a deep insight into the true nature of your API — and whether it’s ready for the challenges ahead.

Here’s what they can uncover:

✅ Solubility profile – helps determine the need for enhancers or salt forms.

✅ Stability under stress – reveals how your API reacts to heat, light, pH, and humidity.

✅ Compatibility with excipients – prevents costly reformulation down the line.

✅ Polymorphism or particle behavior – directly affects dissolution and bioavailability.

Skipping this step is like building a house without checking the ground first.
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👉 Start smart — invest in preformulation.
It’s not just data; it’s your project’s foundation.

28/07/2025

What the EMA Wants to See in Your Biosimilar File

When submitting a biosimilar file to the European Medicines Agency (EMA), it’s not just about proving “similarity.” The EMA expects comprehensive evidence that demonstrates quality, safety, and efficacy equivalent to the reference product.

Key Expectations from the EMA:
1. Analytical Similarity: Detailed comparability studies (physicochemical, structural, and functional) to prove the biosimilar is highly similar to the originator.
2. Non-Clinical Studies: In-vitro and in-vivo studies that evaluate pharmacodynamics and potential immunogenicity.
3. Clinical Data: Robust pharmacokinetics (PK) and pharmacodynamics (PD) data, plus at least one confirmatory clinical study for safety and efficacy.
4. Immunogenicity Assessment: A clear evaluation of the immune response risk compared to the reference drug.
5. Stability Studies: Long-term and accelerated stability data to ensure product performance throughout its shelf life.

At Cobalt Research, we structure biosimilar submissions to align precisely with EMA guidelines, minimizing queries and accelerating approval timelines.

Need expert support for your EMA biosimilar submission? Contact our team today.

27/07/2025

https://www.youtube.com/watch?v=EoQn77B6QMg

📌 What to Keep in Mind for EMA ComplianceGetting a formulation through the EMA takes more than just strong lab data. In this video, we cover the key element...

22/07/2025

Why Photostability Testing Is a Regulatory Must

Photostability testing isn’t optional — it’s a regulatory requirement that ensures your product remains safe, effective, and stable when exposed to light.

☀️ Many pharmaceutical compounds degrade when exposed to UV or visible light. This can lead to:

Reduced potency

Formation of toxic degradation products

Changes in appearance or physical stability

📋 Regulatory bodies like ICH (Q1B) require photostability studies as part of the stability testing package — especially for products in transparent packaging or those intended for light-exposed environments.

💡 At Cobalt Research, we perform controlled photostability studies under ICH-compliant conditions to detect any photo-induced changes and help you mitigate risk before submission.

Want to learn how we can support your product's stability profile?

📩 Contact us to ensure you're light-years ahead in regulatory compliance.

21/07/2025

🔬 Analytical Fingerprinting: What It Means for Biosimilars

In biosimilar development, analytical fingerprinting is more than just comparison — it’s about proving you're nearly identical to the reference product in all critical aspects.

📌 What is it?
A highly detailed analytical profile that uses orthogonal techniques (like HPLC, CE, MS) to map out the structure, charge variants, and functional properties of a biologic.

💡 Why it matters?
Because regulators demand more than “similarity.” They want scientific certainty that the biosimilar behaves the same — structurally and functionally — across multiple batches.

🔍 Our approach at Cobalt Research
We build a layered fingerprinting strategy that supports biosimilarity claims with confidence — reducing regulatory risk and accelerating approval timelines.

Ready to make your biosimilar stand out for the right reasons?

20/07/2025

🧪 Forced Degradation Profiles: Why They Matter to Regulators

Forced degradation studies aren’t just technical exercises — they’re a regulatory expectation that speaks directly to product quality and stability.

Here’s why they’re so critical:

🔍 Understanding Degradation Pathways
By intentionally stressing the drug under heat, light, pH, and oxidation, we uncover how the molecule breaks down — and what impurities may form.

📊 Establishing Stability-Indicating Methods
A validated analytical method must be able to distinguish the active ingredient from its degradation products. Without this, your method may not be accepted.

📁 Supporting Shelf-Life Justification
Regulators want to see real evidence that the claimed shelf life is backed by science — not estimates. Forced degradation helps build that case.

🛡️ Safety First
Unknown or uncharacterized degradants raise concerns. Showing you’ve assessed them thoroughly builds confidence in your product’s safety profile.

💼 At Cobalt Research, we design regulatory-trusted forced degradation studies that form the backbone of robust CTD submissions.

20/07/2025

🚦 Cross-Functional Review: Why Regulatory Should Be Involved Early

In drug development, early decisions can make or break your submission timeline. One of the most overlooked strategies? Involving the Regulatory Affairs team from day one.

Here’s why it matters:

🔹 Formulation Impact
Regulatory teams can flag excipients or processes that might raise red flags with authorities — before you spend time and money scaling them.

🔹 Clinical Strategy Alignment
Early input ensures that your protocol design aligns with evolving regulatory expectations, especially for fast-track or orphan designations.

🔹 Data Package Planning
From Module 3 formatting to stability study design, Regulatory Affairs can guide what data is needed — and how it should be presented.

🔹 Avoiding Rework
Many delays stem from changes made after submission feedback. Cross-functional input early on prevents costly revisions and backtracking.

💡 At Cobalt Research, we integrate Regulatory from R&D through to submission — because the best strategy is built from the start.

19/07/2025

Granulation Techniques: When to Use Wet vs. Dry Methods

Choosing the right granulation method doesn’t just impact the formulation—it directly affects product quality and stability.

🔹 Wet Granulation
Ideal when powders don’t compress well on their own.
It’s great for achieving uniform distribution of APIs but not suitable for moisture- or heat-sensitive compounds.

🔹 Dry Granulation
Best used when the powder has good flow and compressibility.
It’s suitable for moisture-sensitive APIs, but may not work well if the powder doesn’t bind without a granulating agent.

The decision depends on the properties of your API, desired product quality, and manufacturing capabilities.

18/07/2025

✅ Real Case: How We Saved a Product from Delays with Rapid Stability Support

One of our clients was on the verge of missing a critical launch deadline. The reason? A gap in their stability data that would’ve led to immediate rejection by regulatory authorities.

They came to us just in time.

📌 What We Did:

We quickly assessed the formulation and existing documentation.

Designed an accelerated stability study protocol tailored to the product's profile.

Managed end-to-end ex*****on — from sample preparation to data analysis.

Delivered fast-track stability data aligned with ICH guidelines and regulatory expectations.

Thanks to our rapid support, the client was able to submit on schedule — no delays, no rejections.

💡 This case is a strong reminder that smart planning and expert guidance can turn regulatory risks into regulatory wins.

📩 Facing a tight deadline or data gap? Let’s talk.

17/07/2025

💡 Did you know that 72% of delays in regulatory submissions are caused by something as simple — and preventable — as formatting errors?

These errors range from:

Incorrect module structure in CTD/eCTD

Missing bookmarks or hyperlinked sections

Non-compliant fonts or margins

Wrong file naming conventions..to inconsistent metadata that confuses authorities.

✅ At Cobalt Research, our regulatory team uses automated validation tools and a strict quality review process to catch these issues before they become problems — saving you weeks or even months in regulatory back-and-forth.

Don’t let formatting stop your science from moving forward.