Recombinant Proteins & Antibody CDMO Solutions
Get to the clinic faster by partnering with the premier CDMO for your Recombinant Protein and Antibody production needs.
Process Development
First Time Right.
Cost-Efficient.
Bullet-Proof Documentation.
We develop scalable, robust and GMP-compliant manufacturing processes for recombinant proteins and antibodies.
- Upstream Process Development
- Downstream Process Development
- Analytical Development
- In Silico Cost Modeling
Optimize your protein expression with our upstream process development for recombinant proteins and antibodies.
Our expertise encompasses selecting a suitable host cell line and optimizing conditions for high-yield protein expression.
Ensuring high levels of protein expression is crucial for cost-effectiveness, scalability, and meeting regulatory requirements for product quality. Additionally, optimizing protein expression also helps to minimize impurities and reduce the complexity of downstream purification, which further contributes to the overall success of your process development.
Develop improved or completely novel purification processes.
In downstream process development for recombinant proteins and antibodies, developing an efficient and effective purification strategy is pivotal. We typically adhere to Design of Experiments (DoE) and Quality by Design (QbD) tools to efficiently anchor purification steps and monitor the key process parameters for scale-up.
A well-designed purification process can result in a high-quality and pure final product, meeting regulatory requirements, and ensuring the desired therapeutic efficacy. Additionally, optimizing the downstream process can also help to increase product yields, reduce costs, and improve the scalability of the manufacturing process.
Establish robust and reliable analytical methods to ensure the quality, identity, purity, and stability of your product.
Our expertise includes developing methods for quantifying your protein, characterizing its structure, determining the presence of impurities, and monitoring stability during storage and transportation.
Robust analytical methods are critical for ensuring that your product meets regulatory requirements, and providing the data needed to make informed decisions about product development and manufacturing.
Make well-informed decisions quickly with In silico Modeling.
Our in silico expertise saves time and resources during the development phase and manufacturing of recombinant proteins. The software integrates up-to-date information from across the biopharmaceutical sector with the latest industry-benchmarked price information for materials, consumables and equipment.
With our in silico modeling expertise and software systems, we are able to save significantly on manufacturing costs by understanding cost structures early in the development of non-platform processes and platform processes.
Manufacturing Solutions
Partner with a leader in recombinant protein & antibodies CDMO services.
We have successfully delivered protein-based pharmaceuticals, including biosimilar enzymes, growth factors, fertility hormones, clotting factors, antibodies, antibody fragments, viral proteins and antigens.
Produce a high-quality and reproducible product to support your preclinical testing.
We help you select appropriate cell lines, optimize expression and purification processes, and scaling up production to generate sufficient amounts of product for testing.
Your preclinical product should meet the required quality specifications, such as purity, identity, and activity, and must be manufactured consistently to support the robustness and reproducibility of preclinical data. Additionally, effective preclinical manufacturing also helps to identify and address any challenges or limitations that may impact later stages of development and commercialization.
Get high-quality and consistent product that is safe and effective for patients.
Your clinical product should be manufactured consistently and under strict quality control to support the robustness and reproducibility of clinical data. Effective clinical manufacturing also helps to ensure that the product can be produced consistently at commercial scale to meet the needs of patients.
Our GMP facilities are suited to generate a product that supports your clinical trials and for scaling up production to meet clinical demand for a marketable therapeutic protein or antibody.
Ensuring compliance with regulatory standards and requirements.
Our support goes beyond proper documentation, testing and data analysis to support product quality, safety, and efficacy claims.
A successful regulatory strategy is critical for bringing recombinant proteins and antibodies to market and ensuring they are available to patients who need them. Our regulatory experts can help you prepare for successful submission of regulatory applications.
Technologies for Recombinant Protein & Antibody Development & Manufacturing
Improve product yield, reduce process development time & increase product stability.
