Drug Process Development | Downstream Process Development

By utilizing our established cell line and platform process we rapidly develop and streamline your program development and commercial timelines.

Our process development platform is defined and designed to ensure scale up directly from bench scale to final manufacturing.

Applying decades of experience, we successfully transfer your existing process, or develop new, innovative processes to meet your objectives.

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Our Process Development Capabilities

Development capabilities include:
- Experience with multiple mammalian cell types including CHO, ABZ-CHO K-1, sp2/0, yp2/0, and NSO
- Experience beyond mAbs including fabs, ADCs, oligonucleotides, nanoparticles, bispecifics, fusion proteins, vaccines, virus-like particles, enzymes, and bioconjugates
- Transfer verification optimization of your process
- Design of statistical experiments to optimize media feeds and growth conditions
- Scale down fed batch and perfusion production models
- Robotic systems from 250ml to manufacturing scale at 2K
- High cell density and titer optimization
- Bench scale process characterization and validation
- Coordination with Analytical Method Development (AMD) to determine quality attributes

Material generated from the upstream process is used to develop your downstream process as well as provide early stage material for analytical and formulation development.

We optimize your downstream processes to remove impurities and increase yields with minimal steps and optimal recovery.

Our capabilities:

Harvest optimization through depth filtration or combined with continuous centrifugation
Chromatography steps utilizing all models e.g., affinity, ion-exchange, hydrophobic interaction, metal affinity, etc.
Column chromatography from 1 ml through 10 L of bed volume
Filter sizing studies
Viral filtration determination and viral clearance validation
Stability on process intermediates and process hold steps
Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs) validation

Learn more about our commercial manufacturing

Offering a full spectrum of services, we support stability for drug substance and in-use testing per ICH guidelines. Stability indicating assays are identified early on via forced degradation studies performed during process development.

Following completion of stability time point testing, a final stability summary report is provided to support your clinical studies and market authorization applications.

Get in touch

Work with us

We successfully transfer your existing process, or develop new, innovative processes to meet your objectives ensuring your overall success in delivering vital medicines to patients.

Biologic Process
Development

Applying decades of experience, we successfully transfer your existing process, or develop new, innovative processes to meet your objectives.

Our Process Development Capabilities

Material generated from the upstream process is used to develop your downstream process as well as provide early stage material for analytical and formulation development.

We optimize your downstream processes to remove impurities and increase yields with minimal steps and optimal recovery.

Offering a full spectrum of services, we support stability for drug substance and in-use testing per ICH guidelines. Stability indicating assays are identified early on via forced degradation studies performed during process development.

Following completion of stability time point testing, a final stability summary report is provided to support your clinical studies and market authorization applications.

Work with us

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Biologic Process Development

Applying decades of experience, we successfully transfer your existing process, or develop new, innovative processes to meet your objectives.

Our Process Development Capabilities

Material generated from the upstream process is used to develop your downstream process as well as provide early stage material for analytical and formulation development.

We optimize your downstream processes to remove impurities and increase yields with minimal steps and optimal recovery.

Offering a full spectrum of services, we support stability for drug substance and in-use testing per ICH guidelines. Stability indicating assays are identified early on via forced degradation studies performed during process development.

Following completion of stability time point testing, a final stability summary report is provided to support your clinical studies and market authorization applications.

Work with us

Related Content

Cell Line Development (CLD)

Analytical Method Development

Biologic Process
Development