Scalable Intelligent Biomanufacturing of BC99

Industrialization of Probiotics

Following more than a decade of industrial research,BC99 has successfully transitioned from laboratory-scale production to

large-scale manufacturing.Through continuous process optimization,the technology has consistently overcome technical barriers. The production process employs advanced fermentation technologies and a rigorous quality control system,ensuring that each

batch of the product possesses stable and highly effective probiotic properties.

Currently,BC99 can provide probiotics powder with a specification of 300 Billion CFU/g tailored to application needs. The product demonstrates excellent stability and is free from harmful substances such as melamine,aflatoxins,and  plasticizers,meeting the requirements for healthy foods.

Furthermore,to meet the demands of diverse markets,BC99 has been developed into various dosage forms,including capsules,   powders,and tablets,providing consumers with the flexibility to choose a suitable administration method based on their individual needs and preferences.

Through the  application  of a  0.1mL-6T  stepwise  scale-up  validation  and  post-processing  industrial  technology

platform,BC99  and other strains  have  successfully  achieved  seamless  transition from  laboratory  to  industrial

production,accompanied  by  continuous  process  engineering  optimization.During  the  production  phase,the  BC99    manufacturing  line  is  equipped  with  high-precision  detection  instruments  that  enable  real-time  monitoring  of  critical fermentation   parameters-including    pH,dissolved   oxygen    concentration,and   nutrient    consumption-thereby   ensur-   ing  a  stable  and  controlled  production  environment.Furthermore,refined  management  practices  have  been  imple-    mented  across  all  production  stages,including  raw  material  selection,fermentation  control,drying  processes,and

packaging,further  enhancing  the  purity  and  activity  of  the  final  product.

WecSimLarge-Scale Intelligent Manufacturing of Microbial Strains

Employing  an  intelligent  control  system,the  entire  production  process  of  BC99  is  carried  out  in  a  GMP-compliant  constant

temperature  and  humidity  purification  workshop  that  meets  pharmaceutical-grade  standards.A  200-ton  fermentation  system     efficiently  achieves  high-density  cultivation  of  the  bacterial  cells,which  are  subsequently  subjected  to  fine  processing  through     multi-stage  centrifugal  separation  technology.The   bacterial  cells  are   ultimately  transformed   into  a   high-quality  bacterial  powder product  via  a  spray-drying  system.

Testing Methods

An  independent  testing  center  has  established  a  comprehensive,multi-dimensional  quality  control  system  for  probiotics,

enabling  precise  monitoring  of  strain   counts,purity  identification,verification  of  authentic   strain  addition,and  prevention  of non-target   microbial   contamination.

Stability  Evaluation

Stability

BC99 probiotics powder can be stored under ambient conditions,with a shelf life of  36 months from the date of manufacture.In accordance with the ICH guidelines on   climatic zone stability,stability assessments were conducted on BC99 products,and the test results confirmed compliance with product quality requirements

    Heat Resistance

    Heat resistance testing was conducted on BC99 probiotics powder.The results demonstrated that BC99 can tolerate temperatures as high as 150℃.After

treatment at 150℃ for 30 minutes,the survival rate remained at 64%.