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Manufacturing Process Scale Up

CDMO expertise for manufacturing process scale up. Whether you're moving into FIH clinical trials, or scaling for commercialisation, our end-to-end services can support at every stage.

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Process Scale up

Manufacturing Process Scale Up

One of the most critical stages in drug development is the transition from development-scale manufacture to larger-scale production. At this point, the drug is produced on a larger scale for either human clinical trials or for eventual commercialisation.

Ensuring this process goes smoothly is essential for both patient safety, and for avoiding delays at a critical point in the product development timeline. 

Whilst this stage can be complex, experienced CDMOs will be able to guide your project through common challenges and enlist support from senior leaders to make your project scale up smooth and successful. 

01

Scale-Up
Challenge

  • Yield loss during scale transition
  • Detection of impurities
  • Equipment misalignment
  • Safety risk
02

CDMO
Solution

  • Pilot Studies
  • Impurity profiling
  • Early equipment assessment
  • Thorough risk assessment

Process Scale Up

How to choose a CDMO Scale Up Partner

Whilst no two scale up projects are the same, there are some steps that biotechs can take to place themselves in the best possible position moving into their scale up operation. 

01

Choose experienced partners

Your choice in partner is a make-or-break moment in guaranteeing commercial success. These partners provide you with invaluable expertise in guiding you through and executing your scale up operation.

02

Select a right-sized CDMO

Small to medium sized biotechs risk being deprioritised for larger projects when they work with large CDMOs. Meanwhile choosing a CDMO that is too small for your project can create problems with equipment. At Upperton, we specialise in small to medium-sized biotechs and have extensive experience at every level of the business.

03

Plan for regulatory expectations early on

Planning for regulatory expectation as you move into scale up and partner selection will save problems at later stages and smooth the transition moving into commercial manufacturing.

YOUR STRATEGIC CDMO PARTNER

Partner with Upperton

We provide fully integrated CDMO services across every stage of the drug product lifecycle.

One Site

Award-winning facility built for scale and continuity providing integrated, end-to-end capabilities delivered under one roof.

One Team

The same team from your early-stage development through to preparation for commercial readiness.

Dosage Form Expertise

Proven track record in solving formulation and delivery challenges across multiple dosage forms.

Executive Leadership on Every Project

Direct access to experienced senior leadership for strategic oversight and decision-making.

Got questions around scale-up?

Speak to our SME team about your project.

#01

Related Services

·   Tech Transfer
·   GMP Clinical Manufacturing
·   Packaging and QP Release

#02

Related Content

·  Transitioning from Formulation Development to Phase 1 Clinical Trials
·   API Challenges in Early Stage Formulation Development, Part 1
·   API Challenges in early stage formulation development, part 2

Award-winning for our service delivery

medlink - outstanding award - 2026
Medilink Service Delivery Award 2026
Contract Services Award - Upperton Pharma
Quality Assurance Award - Upperton Pharma

Process Scale Up FAQs

One of the most common errors when it comes to manufacturing scale up is rushing to manufacturing before fully evaluating and optimising the agreed upon processes. Rushing through this important step leads to problems that occur exponentially, wherein operational difficulties occur resulting in failed batches, high costs and sub-optimal processes for larger batch sizes. 

When it comes to manufacturing scale up projects, bringing in your CDMO as early as possible is the best possible course of action for the project. For example, selecting a CDMO at the pre-formulation stage allows you to consider the type of equipment that is likely to be used, the timelines on access to space, and any further considerations that could impact your project at an earlier stage prior to scale up. 

Yes, there are multiple factors that determine the complexity of a scale up project. For example, the complexity of the formulation varies between project, with some including poorly soluble molecules that require much tighter control or particle size, whilst lipid-based formulations rely upon precise ratios to prevent phase separation. Additionally, spray-dried dispersions can be challenging as they have thermal and airflow dynamics that change dramatically at scale. 

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