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OVERVIEW CDMO SERVICES FOR PROTEINS & ANTIBODIES

Integrated CDMO Services for Proteins and Antibodies

You have identified your lead candidates and want to transition from the preclinical to clinical stage as efficiently as possible, while ensuring quality and functionality?  

Then partnering with an experienced CDMO that can provide everything from cell line and process development to (GMP) manufacturing - including comprehensive analytical services - is the best way forward!

IN A NUTSHELL

The Experienced CDMO for Your Biologics

Whether you want to produce a conventional monoclonal, mAb fragments, a more complex multivalent mAb-like format, fusion proteins, or a therapeutic enzyme, we are your trusted and highly experienced partner for development and manufacturing. From unique cell lines to large scale production, our process is tailored to your individual requirements. Guided by our experienced project managers, we ensure a positive customer journey by navigating the entire process with expertise and care. 

Expect best-in-class efficiency and competitive timelines combined with excellent customer service. 

ProBioGen Protein Services

+

Cell Lines Developed

<

Months from Gene to DP

~

GMP Batches/Year

SOME MOLECULES WE HAVE WORKED WITH

Innovative & Complex Molecules Are Our Business

Monoclonal Antibodies
Monoclonal
Antibodies
Bispecific Antibody
Bispecific
Antibodies
Multispecific Antibodies
Multispecific
Antibodies
FC fusion Protein
Fc Focused
Protein
Antibody Fragments
Antibody
Fragments
Recombinant Protein
Recombinant
Proteins
Cytokines
Cytokines
Enzymes
Enzymes
Clotting factors
Clotting Factors

 

SERVICE OVERVIEW

Integrated or Stand-Alone CDMO Services?

Cell Line Development (CLD)
Cell Banking (MCBs & WCBs)
Process Development (USP & DSP)
(GMP) Manufacturing
Technology Transfer
Analytics & Bioassays
HOW WE WORK

CMC Navigator ™ – A Structured Framework to Select the Right CMC Path

CMC Navigator 800 px

As biologics programs advance, Chemistry, Manufacturing and Controls (CMC) requirements evolve. Different development priorities call for different CMC setups. Whether the focus is rapid first-in-human entry, preparation for later-stage transfer, targeted CMC support, or improvement of an existing cell line and the production process - clients need adaptable solutions that meet them wherever they are in their journey

CMC Navigator™ is ProBioGen’s structured framework of four clearly defined CMC service models, designed to support biopharmaceutical companies across all stages of protein CMC development. CMC Navigator provides clear entry points and transparent scope, helping teams align CMC strategy, timelines, budgets and execution with their current program priorities, so that they can move forward with clarity and control.

Sprint 800 px

From DNA to clinic, on a fast track. 

Sprint provides a streamlined pathway for when reaching first-in-human quickly is critical. Using integrated, platform-based workflows and a clearly defined scope, your program progresses efficiently with reduced timelines and focused execution, from sequence to GMP drug substance for clinical supply. 

 

Scale 800 px

Built for today, ready for tomorrow.

Scale is suited for programs that require clinical material now while preparing for later-stage development or technology transfer. Your future-proof CMC setup is designed with scalability, documentation quality, and transfer-readiness considered from the outset.
Customise 800 px

Only what you are ready for. 

Customize applies when specific CMC activities need to be addressed within an existing development strategy. Our modular format gives you the flexibility to select only the CMC elements as stand-alone work packages – without committing to an integrated end-to-end model.

Rise 800 px

Don’t start over, start better. 

Rise is intended for programs already in the clinic where CMC optimization is required. Existing cell lines or manufacturing processes are re-engineered to improve titer, robustness, performance and suitability for continued clinical development.

 

CMC SERVICE MODELS

CMC Navigator™ - Protein CMC Collaboration Framework

CMC Navigator 800 px

Four paths. One clear way forward.

As biologics programs advance, Chemistry, Manufacturing and Controls (CMC) requirements evolve. Different development priorities call for different CMC setups. Whether the focus is rapid first-in-human entry, preparation for later-stage transfer, targeted CMC support, or improvement of an existing cell line and the production process — clients need adaptable solutions that meet them wherever they are in their journey.

CMC Navigator™ is ProBioGen’s structured framework of four clearly defined CMC service models, designed to support biopharmaceutical companies across all stages of protein CMC development. CMC Navigator provides clear entry points and transparent scope, helping teams align CMC strategy, timelines, budgets and execution with their current program priorities, so that they can move forward with clarity and control.


Sprint 800 px

Sprint

From DNA to Clinic, on a Fast Track.

Sprint provides a streamlined path when reaching first-in-human is critical. With proven platform processes and clear scope, your program moves fast and efficiently from sequence to GMP drug substance.


Scale 800 px

Scale

Built for Today, Ready for Tomorrow.

Scale is suited for programs needing clinical material now while preparing for later-stage development or technology transfer. Your CMC setup is built for scalability, documentation quality and transfer-readiness.


Customise 800 px

Customize

Only What You Are Ready For.

Customize applies when specific CMC activities need to be addressed within an existing development strategy. Our modular format gives you the flexibility to select the CMC elements as stand-alone work packages.


Rise 800 px

Rise

Don’t Start Over, Start Better.
 

Rise supports clinical-stage programs needing CMC optimization. Existing cell lines or processes are re-engineered to improve titer, robustness and performance for continued development.

WHY ONE-STOP-SHOP?

Accelerated Timelines

Achieve accelerated timelines with our integrated CDMO services, taking your antibody from sequence to IND in just 12 months*. By combining cell line development, process development manufacturing and analytics under one roof, we streamline workflows and enable overlapping project phases. This allows to drastically reduce timelines without increasing risk.

Our expert project management office (PMO) acts as a dedicated customer interface, facilitating fast decision-making, solving challenges efficiently, and driving molecules seamlessly through the process.

Accelerated Timelines
From Gene to Drug Product in < 12 Months - mAB*

Our Promise To You

Time is Money
 
Rely on Fast Timelines
  • One-Stop-Shop with seamless, integrated Services
  • Parallel Processes
  • Efficient project execution
Success
 
Get Your High Quality Candidate
  • Successful track record with complex molecules and projects
  • Proprietary technologies elevate product quality
  • Strong analytics teams and stellar quality management services
Asset 18
 
Have the Flexibility You Need
  • Choose from modular offerings
  • Strong partnership approach
  • Experienced project managers and efficient decision-making processes
 

Elevate Your Candidate With The Right CDMO

Explore Related Services

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GMP Manufacturing

Cell Banking

Cell Banking

Technology Transfer

Technology Transfer

Process Development

Process Development

Analytics & Bioassays

Analytics & Bioassays

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