CDMO SERVICES FOR PROTEINS & ANTIBODIES

Biosimilars and Biobetters

You want to create a high-performance biosimilar or a biobetter with improved product properties at a reasonable cost?

Our expertise in generating mammalian cell-derived biosimilars has been honed for over a decade and helps us ensure reliability and rapid progress. Transitioning seamlessly from market-ready biosimilars to our innovative biobetters, we pave the way for cost-effective solutions that elevate patient care.

IN A NUTSHELL

Biosimilars and Biobetters for Affordable Treatments

Relying on our proprietary technologies, we provide you with a smart cell line and process development as well as the secure manufacture of clinical batches in a timely manner. The entire process is monitored and controlled by head-to-head comparison to the reference medicinal product (RMP) and complemented by a biosimilarity assessment to ensure similarity.

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HOW WE WORK

Our Expertise - Your Success

One-Stop-Shop

We conceptualize your biosimilar candidate as a one-stop-shop service and maximize its similarity to the originator. Since analytical and functional characterization are key for biosimilarity, we place attention on the quality target product profile (QTPP) of the RMP.

Fully Centered on Quality and Compliance

We continuously refine and adjust our processes and technologies to adhere with the latest regulatory requirements and remain state-of-the-art. Development, manufacturing, and analytics are defined and controlled in accordance with the critical quality attributes (CQA) for process and product.

Proprietary Vectors, Media Platform and Best-in-Class Technologies

Own CHO.RiGHT® Expression Platform

We provide suitable host cell lines to maximize biosimilarity. These include our classical CHO cell lines like CHO-DG44 and CHO-K1 PBG.

We evaluate suitable expression vector constructs (single-chain or multiple-chain vectors, different ratios, amplifying vector elements).

Integrated Analytics

The early process development for biosimilar candidates is accompanied by comprehensive metabolite analysis in e. g. BioProfile® FLEX2 or CuBiAn HT270 and cellular analysis in high-throughput automated systems like Cellaca™ MX cell counter, Vi-CELL, NYONE® imager, and FACS.

Process Development for Biosimilars

Another key component of our biosimilar development is our early and small-scale process development using multi parallel bioreactors like Ambr® 15, DASGIP®, and DASbox® systems. Process development is supported by comprehensive metabolite analysis in e. g. BioProfile FLEX2 or CuBiAn HT270 and cellular analysis in high-throughput automated systems like Cellaca, MX cell counter, Vi-CELL, NYONE imager, and FACS. In order to shorten the timelines, the early process development starts with clone pools alongside the automated CLD in ProBioGen's PSIbot system.

Product Characterization & Biosimilarity Assessment

An extended panel of physico-chemical methods is used for development and in-process analytics. In order to secure comparable product quality, safety and efficacy bioassays as well as cell-based bioactivity assays are available.

Extensive physicochemical and functional analyses are carried out in head-to-head comparison with the RMP in order to control and match biosimilarity. Based on the QTPP of the RMP, CQA are defined. Biosimilarity assessment starts in early CLD and supports all stages of process development, manufacturing, and stability studies. This assessment can be transitioned into a comparability exercise for process changes and transfer, if needed.

Types of Molecules We’ve Worked With

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Our Promise to You

Rely on Fast Timelines

One-Stop-Shop with seamless, integrated Services
Parallel Processes
Efficient project execution
Do it right from the beginning

Get Your High Quality Candidate

Scientific excellence
Deep understanding for molecule / Long + broad experience
Strong Analytics teams and stellar quality management services
Enabling technologies

Have the Flexibility You Need

Modular Offering
Customer Centricity/ Strong Partnership Approach
Experienced Project Managers and efficient decision-making

Our Promise To You

Comparability Secured

Comprehensive originator assessment for a reliable quality target product profile (QTPP)
Early biosimilar candidate testing to adjust and align with the critical quality attributes (CQA)
Superior technologies to adjust and boost performance

Maximum Reliability

Highly experienced project teams headed by our project management office (PMO)
Integrated development, GMP manufacturing, and analytics
Similarity and compliance through quality by design (QbD)

Reasonable Costs and Timelines

Efficient process development, manufacturing, and reports
Cost efficient development and manufacturing achieved by controlling the cost of goods (CoGs) and scaling to demand
Fast track approach with accelerated timelines in CLD, USP, and DSP