Early development and commercial programs for biologics

A science-driven approach from lab to market

Now that you’ve made a great discovery, how you do you transform it into a drug substance and later, a drug product? With more than 30 years of process development experience, including more than 240 biologic development programs, we can help guide you. Our experts and solutions in early development, clinical and commercial manufacturing, and process characterization and validation will nurture your molecule from lab to market—whether you bring your own cell line, media, and process, or take advantage of our world-class ecosystem. 

25 BLA submissions

We have demonstrated scientific and regulatory expertise, with ~25 BLA submissions completed over the past five years. 

42 customers in 11 countries

From 2018-2020, we worked on biologics projects with 42 customers in 11 countries. 

288 GMP batches

We completed 153 GMP batches in 2019 and 135 in 2020. 

63% of projects for monoclonal antibody

From 2018-2020, 63% of our new biologics projects were for monoclonal antibody products. 

25 BLA submissions

We have demonstrated scientific and regulatory expertise, with ~25 BLA submissions completed over the past five years. 

42 customers in 11 countries

From 2018-2020, we worked on biologics projects with 42 customers in 11 countries. 

288 GMP batches

We completed 153 GMP batches in 2019 and 135 in 2020. 

63% of projects for monoclonal antibody

From 2018-2020, 63% of our new biologics projects were for monoclonal antibody products. 

 

We offer a science-driven approach to every step of the development and manufacturing process combined with powerful digital tools, supply assurance, regulatory support, and secure trial execution. Designed for speed, our early development and commercial programs for biologics are fast and comprehensive so that we can help your treatments reach those who need them most. 

Helpful resources 


Biologics solutions and capabilities

Complete validation package to support regulatory submission

As we work with you to establish commercial supply, we provide a complete validation package based on regulatory and cGMP guidelines. 

  • Broad mammalian cell culture experience: mAbs, fusion proteins, bi-specifics, enzymes, fragments, and other recombinant proteins
  • Fed-batch, perfusion, and XD® cell culture processes
  • Design of Experiment (DoE) studies
  • Sartorius ambr® 15 and 250 microbioreactor systems
  • Glass and single-use bioreactors (3 L to 250 L)
  • Media/feed strategy optimization
  • Resin screening
  • Tecan Freedom EVO® platform with Repligen RoboColumn® system
  • UF/DF development
  • Virus clearance studies
  • TProcess and product characterization 

It’s challenging to manuever today’s dynamic development environment, where changes seem to happen from moment to moment. Unleashing the power of your discovery requires speedy decisions and trusted expertise. Reliable manufacturing processes are essential to ensuring the very highest quality for all drug substances and drug products. In the race to the clinic, you need to establish a robust and cost-effective process quickly because timing is critical, and there is no room for error.

We apply our deep process development skills to dramatically increase the batch yield and significantly reduce processing time for your molecule. Combining comprehensive upstream and downstream process development capabilities with our commitment to innovation, quality, and service, we are your ideal partner. Our experts have the experience and capabilities to develop an optimal process with long-term commercial manufacturing in sight.  

  • Process validation with an integrated control strategy 
  • Validation of analytical assays
  • Virus validation of the downstream process
  • Impurity clearance
  • Resin re-use
  • In-process hold time studies
  • ICH stability studies
  • Container shipment studies 
  • Release testing
  • CMC documentation in CTD format  

Cell line development plays a major role in developing robust, cost-effective biologic processes. You need the rapid availability of high-performing mammalian cell lines for therapeutic protein production and flexibility. We have the cell lines and scientists to help. Our expertise spans multiple commercial cell lines and cGMP cell banking. 

  • Simple cell line licensing agreements that avoid royalties or restrictions
  • Automation, Beacon, and ambr® 15 platforms to accelerate cell line development and optimize the selection of top clone 
  • Custom cell line development using the Thermo Fisher GibcoTM FreedomTM CHO-STM Kit and other cell lines
  • Experience with commercial cell lines, including CHO, myeloma, hybridoma, and PER.C6®
  • Cell banking services
  • Use of high-density mammalian cell culture technologies, including our proprietary XDTM technology  

To get your molecule into the clinic—and ultimately, your treatment approved—you need rapid process development of the investigational product in an appropriate formulation and at sufficient quantity for trials. We ensure your supply with an eye on future commercial production and efficient transfer to cGMP production.

Early-stage clinical supply

Early-stage biologic drug substance is produced at our state-of-the-art cGMP facilities in Europe, North America, and Asia. A team of experts will use a full range of technologies and analytical services to execute with the highest flexibility and deliver on time with exceptional yields and superior quality.

Late-stage supply and beyond

After preclinical development, our award-winning tech transfer team will move your project to a cGMP facility for scale-up and production. We develop stable and repeatable processes ready for validation by the FDA and identify areas of risk within the biomanufacturing process. 

Quick to ClinicTM is an integrated early development offering designed for biotech companies looking for a dependable solution to scale up recombinant antibodies from discovery to first-in-human (FIH) trials. With Quick to Clinic, you balance early development timelines, risks, and future scale-up and commercialization needs.

Speed up

Speed up your early development to as little as 13 months from the start of transfection to IND with best-in-class technologies, allowing you to file faster and get to patients sooner. 

  • Platform cell culture and purification processes and analytical methods
  • Drug substance and drug product activities conducted in parallel
  • High throughput automation technologies
  • Streamlined drug substance and product handovers and pre- qualification of common vial formats  

 

Manage risk

Manage risk and secure supply leveraging our broad technology portfolio and deep scientific expertise. You won’t have to sacrifice quality for speed. 

  • Avoiding high-risk activities
  • Using templated, pre-prepared documentation
  • Drawing from more than 30 years of expertise developing over 100 recombinant protein products  

Prepare for the future

Getting your molecule from discovery to IND faster is just the first step. Prepare for long-term commercialization with our high-yield expression system and robust process platform. 

  • Leveraging the GibcoTM FreedomTM ExpiCHO-STM cell line with no royalty payments
  • Drawing on strong commercialization experience
  • Using a robust platform and trusted cell line  

We have particular expertise in integrated and efficient technology transfers—carrying out 185 in 2017 alone, including 138 for commercial projects, 44 for drug substances, and three for development projects.

Technology transfers represent an opportunity to use our integration and efficiency to give you a strategic and financial advantage. Tech transfers, for scale-up or to move a project between facilities, are part of our normal course of business. Even when the transfer is urgent, we can execute it quickly and effectively to get your project back on track and preserve product supply. In all cases, we are driven by your deadlines, flexible in our approach, and determined to get it right the first time, every time. 

  • Single-use cGMP bioreactors: 500 L, 1000 L, 2000 L, and 5000 L
  • Multiple single-use platforms supported
  • Fed-batch, perfusion, and XD® cell culture technology Extensive technology transfer experience
  • Australian R&D tax credit of up to 43.5%
  • cGMP batch sizes from 10 grams to 10 kilograms of drug substance
  • Flexible biomanufacturing solutions 

cGMP biologics manufacturing

As collaborative partners, we work to ensure commercial biologic manufacturing meets full cGMP conditions. Our team offers speed, efficiency, exceptional quality, and the flexibility to adapt to changes in your journey. We are continuously making investments in capacity, infrastructure, and state-of-the-art technology. 

World-class facilities

Our world-class, state-of-the-art facilities in Europe, North America, and Australia offer the flexibility to adapt to changes in your journey and your product development strategy. 

Integrated network

Our network has more than 60 sites across 23 countries and employs scientists, technicians, and engineers with deep technical expertise—all working together to ensure the success of your molecule.