Process development

Every experiment counts

Every process development program hits inflection points—moments that either compound your progress or stall it. Will your process carry through to scale, or will it force months of rework when time and margins are tight? And is the standard platform approach the best one for your molecule?

At Cytiva, we see those moments as opportunities to build momentum. We bring together the methods, tools, and expertise that help your team make stronger decisions earlier—so your process holds up at every stage, not just the one you're in now.

Process resilience at bench, pilot, and GMP scale

A good process should be transferable, scalable, and defensible. We help you get there with proven technologies, deep application expertise, and practical workflow tools for upstream and downstream process development.

Process design, analytics, and troubleshooting

Model, screen, and optimize upstream and downstream unit operations—using DoE, HTPD, digital tools, or our scientists' hands-on support.

Proven consumables and hardware

The resins, membranes, and systems already used in most approved mAbs and gene therapies—designed for scale-up from day one.

Tech transfer and regulatory readiness

Prepare for site transfer and regulatory filing with complete documentation, data packages, and hands-on submission support.

Hands-on process development or in-house enablement

Our process development scientists work as an extension of your team or take the lead entirely—matched to your capacity, goals, and timeline.

From momentum to patient impact

In 2025, our technologies enabled advanced therapies for 400 million patients¹ across 200+ diseases and conditions² worldwide.

You can rely on us and our deep scientific expertise, equipment, and product engineers to help you make the same translatable difference, whether you're working with traditional mAbs, novel antibodies, viral vectors, or mRNA.

¹An individual patient may be counted more than once if treated with multiple therapies.
²Diseases and conditions according to WHO ICD classification.

Real-world results

Scientists at Boehringer Ingelheim, Molecular Partners, and Roche share tips for using ÄKTA avant™ chromatography systems for process development.

Read the case study

Solutions across modalities

Every modality has different process challenges. mAbs and antibody variants demand platform consistency at scale. mRNA and oligonucleotides require tight control over formulation, purification, and rapidly evolving manufacturing methods. Gene and cell therapies need scalable processes built around inherently variable biology. We support all of them with proven equipment, optimized workflows, and hands-on expertise.

Process development services that meet you where you are

From rapid proof-of-concept studies to full upstream and downstream process development and design, optimization, and even tech transfer—we work with your scientists to get you to your next milestone.

Learn more about our process development services.

Process development services that meet you where you are

Resources for developing your process

Looking for practical guidance? These resources can help you get started, enhance process understanding, and tackle common challenges.

Fundamentals

Early-stage process design

Process characterization and modeling

Scale-up and tech transfer

Troubleshooting

Ask us anything

Tell us about your molecule and timeline, and we'll recommend a starting point. Our process development specialists can help you choose a product, solve a problem, or order samples to try in your lab.

Start a conversation

Frequently asked questions about process development

What information do engineers need before locking a process design?

Before finalizing a process, teams need data on critical process parameters, acceptable operating windows, impurity clearance, and step recoveries. Understanding how variability upstream propagates downstream helps avoid late-stage redesigns and supports smoother scale-up and technology transfer.

How does cell culture process development influence downstream performance?

Cell culture process development affects downstream processing by determining impurity load, product quality attributes, and harvest characteristics. Stable, well-characterised upstream processes reduce variability in clarification, chromatography performance, and filtration behavior during downstream operations.

How do process development activities change during scale-up?

As scale increases, process development shifts toward robustness and control. This includes reducing sensitivity to raw-material variation, minimizing manual interventions, and aligning equipment capacity and flow rates across steps to maintain performance during extended runs and larger batch sizes.

How does process development reduce risk during technology transfer?

Well-defined biologics process development generates clear documentation on process limits, step interactions, and control strategies. This allows transfer teams to reproduce performance at new scales or sites with fewer engineering runs, fewer deviations, and more predictable start-up behavior.

What is the difference between research and development and process development?

Research and development (R&D) focuses on discovering and proving a viable molecule, often prioritizing speed and feasibility. Biologics process development begins once a candidate is selected and concentrates on defining operating ranges, control strategies, and unit operations that can deliver consistent performance as the process scales toward manufacturing. Learn more in this comprehensive introduction to biopharma process development.

What are the main focus areas of downstream process development?

Downstream process development focuses on selecting and sequencing unit operations that remove impurities while maintaining product integrity at target scale. Engineers typically balance recovery, capacity, buffer usage, and cycle time across capture, polishing, and formulation steps to ensure predictable performance and manufacturability.

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Biologics process development. Built to hold.

From process design to manufacturing readiness, we help you make process decisions that don't cause rework or unnecessary variation.