mAbs Development and Manufacturing
Upstream. Downstream. Formulation.
Fed batch and intensified processes.
Process Development and Manufacturing
Monoclonal antibodies (mAbs) are manufactured using a templated approach requiring robust, scalable, and regulatory compliant technologies to ensure success across all steps of the workflow from cell line development to formulation and final fill-finish. This template is also applied for biosimilars and with some modifications for antibody-drug conjugates (ADCs), bispecifics, and other novel antibody formats.
Our Products and Services Support the Following Areas
Upstream
- Cell Line Development
- Media and Buffer Development
- Pre- and Sterile Filtration
- Bioreactors
Downstream
- Clarification
- Prefiltration & Bioburden
- Affinity Chromatography
- Virus Inactivation
- Polishing Chromatography
- Viral Clearance
- Concentration & Diafiltration
Formulation & Final Fill
- Formulation
- Final Filtration and Filling
While the overall bioprocessing workflow is well-established, many technological, analytical, and digital advances can be leveraged across upstream (USP) and downstream (DSP) operations to optimize productivity and gain efficiencies, but also to support closed, intensified, connected, and continuous biomanufacturing.
- Process monitoring, through process analytical technology (PAT), and intensification (e.g. perfusion) of the upstream suite are increasingly applied across different scales from the seed train to production and harvest.
- Productivity improvements in upstream processing are driving process intensification of the downstream workflow to keep pace with higher antibody titers in the feedstream.
- Single use closed processing is being adopted to improve contamination control and facility utilization.
- Biopharma 4.0 principles enabling automated decision making for data-driven intensified and continuous bioprocessing with modular, plug-and-play, connected and digitalized solutions.
- Manufacturing excellence and innovation can be achieved through collaborative exploration and learning. Explore novel modalities or test drive advanced techniques without disrupting your own operations through our global network of non-GMP facilities equipped with scientific experts and high-quality technologies.
Take full advantage of these opportunities to optimize and accelerate your process development and manufacturing. Stay abreast of latest industry trends and compliant with continuously evolving quality control, and regulatory requirements, upskill your workforce, and experience our integrated products, and services as we support the entire drug lifecycle – from preclinical and clinical development through commercial manufacturing of mAbs.
Products You Need Throughout the Process
Scalable, traceable, pure, and cost-effective cell culture is critical for mAb production.
Buffer and media prep are crucial for efficient, safe, and high-yield manufacturing.
Clarification reduces bioreactor impurities for downstream purification.
Downstream purification includes one or more chromatographic separation steps to purify molecules.
Bioburden control is critical to assuring the microbial safety of drugs for patients.
Ultrafiltration & diafiltration increase capacity, concentration, and recovery in bioprocessing.
Several formulation approaches can have an impact on the success of biologics.
Explore Our Solutions
Upstream process intensification enhances efficiency and flexibility for biopharma.
Process intensification enables the downstream suite to be more efficient, faster, and sustainable.
Closed processing mitigates contamination risks, and enables sustainable multi-modal manufacturing.
PAT ensures quality in mAB manufacturing by monitoring and controlling processes in real-time.
Biotech firms need smart data management tools that automatically collect data from disparate sources.
Automation and control software increases process reproducibility, and optimizes uptime.
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