New York, US – September 19, 2019 – With consistent efforts at vaccine field for decades, Creative Biolabs has thoroughly explored a large number of different vaccine development projects and established a comprehensive vaccine platform based on years of experiences. Recently, Creative Biolabs released small-scale process development services.
A successful vaccine GMP manufacturing process requires the strict requirements on scale and security. After a series of basic regulatory standards for vaccine production published by WHO, the new vaccines are supposed to be licensed based on safety and efficacy, as well as the ability to manufacture in a consistent manner.
As is known, the scale differences are always a unique challenge for researchers to scale up and predict. The generation of a small model and its calibration to specifically predict the scale up performance play a significant role in the vaccine development process. In order to better support customers all around the world who are seeking for standard vaccines development services, scientists at Creative Biolabs are capable of developing small-scale process models to deeply understand the product and facilitate prediction and control for vaccine development, characterization, and control strategies. They scientifically and carefully design the small-scale model development to represent the functions and environments that will be presented on a large scale, ensuring a reasonable result prepared for the secondary model adjustment and correction.
“Our skillful experts can develop models that account for scale effects and are representative of the proposed commercial process. The scientifically justified model can enable a prediction of product quality and can be used to support the extrapolation of operating conditions across multiple scales and equipment”, introduced by the senior scientist at Creative Biolabs.
“The final result can help clients assess if it’s adequate for an expected performance, create appropriate specifications, identify critical process parameters, and establish manufacturing controls. It can guarantee a consistent production of APIs and drug products in line with those attributes, such as identity, strength, quality, purity, and potency, and promise acceptable quality products within commercial manufacturing conditions.”
Features of vaccine process development:
Generate product and process models at both scales
Exploration of effective experimental strategy
Effective development of available facilities
Effectively explore control strategies
Increase material usage
Reduce development costs
Save time on exploring developing solutions
Equipped with a skillful team and the latest technology, Creative Biolabs can provide small-model generation to predict performance at scale and small-scale process development with scalability and repeatability.
More information can be reached at https://www.creative-biolabs.com/vaccine/process-development-gmp-manufacturing.htm.
Creative Biolabs, headquartered in New York, is a leading custom service provider in the field of vaccine development, preclinical assessment and GMP manufacturing. The technical and regulatory experts can provide vaccine developers with a full range of products and vaccine related services. Traditional and the most updated genetic engineering technologies are combined to efficiently produce highly immunogenic and safe vaccines to address emergency unmet medical needs. The service portfolio includes a full range of vaccine design for client’s specific requirements that covers vaccine target validation, vaccines targeting bacterial, viral, fungal, parasites, cancer markers and more. Formulation optimization services are also available for maximum potency, including improving delivery systems, a great variety of adjuvant products and services like PRR Ligands scanning and adjuvants synthesis.
Company Name: Creative Biolabs
Contact Person: Candy Swift
Email: Send Email
Address:45-1 Ramsey Road
State: New York
Country: United States