Know-How Academy

Many generic pharmaceutical companies think that successful formulation development means:

- Passing lab trials
- Passing initial stability studies
- Achieving target specifications

But from my 20+ years of experience in pharmaceutical formulation development… this is not always enough.

I have seen many products perform very well at laboratory scale, then suddenly fail during scale-up to production scale.

Why?

Because manufacturing process parameters at lab scale are completely different from commercial production scale.

Different batch sizes.
Different machines.
Different operators.
Different environmental conditions.
Different process dynamics.

And many hidden factors only appear when the product moves to real manufacturing conditions.

That is why Engineering Batch is not a luxury step.
It is a critical risk-reduction step.

In many projects I worked on, the engineering batch acted as the real discovery phase before official validation and commercial batches.

It helps uncover:

• Process weaknesses
• Scale-up challenges
• Flowability issues
• Mixing inconsistencies
• Compression problems
• Stability risks
• Hidden manufacturing variables

Although many companies consider engineering batches as a sunk cost because they are non-commercial batches, in reality they can save enormous future costs related to:

• Batch failures
• Product recalls
• Delayed launches
• Rework
• Investigation time
• Product quality risks

Sometimes, one engineering batch can save an entire product lifecycle.

From your experience in formulation development…

What was the most unexpected manufacturing or scale-up issue that appeared only after moving from lab scale to production scale?

Some of the most expensive pharmaceutical lessons are never discovered inside the lab.

هل نثق في دواء "مش أصلي" لكنه مطابق تقريبًا؟ في عالم الدواء، كانت فكرة استخدام علاج مش هو الأصلي مصدر قلق كبير. لكن مع تطور التكنولوجيا الحيوية، ظهر مفهوم غير قواعد اللعبة: Biosimilar – المستحضر الحيوي المشابه.

هل نثق في دواء مش أصلي ؟ !!!

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هل نثق في دواء "مش أصلي" لكنه مطابق تقريبًا؟ في عالم الدواء، كانت فكرة استخدام علاج مش هو الأصلي مصدر قلق كبير. لكن مع تطور التكنولوجيا الحيوية، ظهر مفهوم غير قواعد اللعبة: Biosimilar – المستحضر الحيوي المشابه.