an introduction for Process Development

1. Process Development & GMP Manufacturing Creative Biolabs will help you with preclinical vaccine research whether your vaccine program requires Live attenuated or Killed Vaccine, Subunit Vaccine, Viral Vector Vaccine, Hapten Conjugate Vaccine, DNA and RNA Vaccine or Total Synthetic Vaccine. Besides, Creative Biolabs will provide Process Development and GMP Manufacturing services to support your vaccine development and commercialization efforts. Our manufacturing services are also complemented by Analytical Development & Qualification and Preclinical Assessment, which allow customers to move their products seamlessly through development. There have been significant changes in the number of companies involved in the production of vaccines in the biotechnology era and the production systems they are using. Scale and security are critical to maintaining a successful manufacturing process. WHO has introduced a set of basic regulatory standards for vaccine production, regardless of the technology used to produce the product. The new vaccine is licensed on the basis of safety and efficacy, as well as the ability to manufacture in a consistent manner. Creative Biolabs will promote the development and evaluation of new vaccines by anticipating and addressing the regulatory issues involved.

2. Fig.2 Process-development scheme for vaccine manufacturing (Suma Ray. 2011) Our Services Evaluation of expression system; Other GPM testing of clients’ products; Serum-free suspension culture; Specific pathogen-free (SPF) eggs for the production of veterinary; Small-scale process development; GMP vaccine production; Scale-up Development; Formulation Development; Expert consultation on vaccine development strategies and detailed product development plans; GMP product analysis and qualification (characterization, stability assays, and potency assays); Regulatory services to prepare, summarize, review, deliver and follow up IND submission; Produce antibodies required for specific assays; GMP safety toxicology and bio-distribution studies.

3. As a leading service company, we offer our clients highly flexible commercial cGMP facilities for the production. Unlike other manufacturing company, our facilities are designed to be flexible. With the increased scale or demand for clinical materials, we have the ability to grow with customers and offer them a customized and attractive project package. With extensive experiences in this field, from vaccine target validation to preclinical assessment, through to GMP manufacturing, we can help you every step of the way. Creative Biolabs prides itself in being able to offer all of our clients information and advice on application technologies and manufacturing matters with our greatest knowledge and competence.