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KareBay Biochem GMP grade peptide, 믿을 수 있는 품질인지 확인하셔야 합니다. 2016-10-31 14:51:03


 

제품 생산에 사용되는 GMP Peptide,

확실한 QC를 통과한 제품을 사용하셔야 합니다.

 
 

-GMP grade peptide 생산설비 및 전문부서 보유

-다양한 제약 기업체 대상 GMP peptide 공급 제휴 체결

-FDA 21 CFR parts 210 & 211 and conforms to ICH Q7A 준수

 

KareBay is ready to build long-term partnerships with clients who are looking for a reliable partner in scale-up API production. Multiple size reactors support manufacturing capacity from gram to kilogram scales. Key equipment such as gas chromatography (GC), analytical HPLC, small and large preparative HPLC systems and MS monitors, as well as are employed to assess each step of manufacturing with complete GMP grade certificates.

 

KareBay also provide cGMP manufacture services according to FDA/ICH standards and the quality management system of Karebay Biochem. The services include the process development studies, peptide manufacture, impurity studies, and full quality control testing reports. KareBay team has a well experienced team in developing, optimizing, manufacturing, and validating the process of analytical production. A typical cGMP peptide is tested in KareBay Biochecm is listed below various specifications.

 
[cGMP Peptides Specific Quality Control List]

Counter Ion Content

One of the major concerns of the processed peptide is the counter ions (i.e. TFA, HOAc, and others), which are mainly from purification process. The counterion content is quantified by chromatographic methods (HPLC, IC, or GC).

Residual Organic Solvent Content

Numerous organic solvents are used in peptide production, and the residual organic solvent content has significant effect on the quality of the peptide product. The Residual Organic Solvent Content is quantified by chromatographic methods (GC) according to USP standards.

Appearance

The physical appearance of the processed peptides is verified visually by QC staff, and in general is reported as white or off-white powder.

Solubility

The solubility of the peptide (mg/mL) depends on the sequence and hydrophobicity of the peptides, as well as other physical environment (solvents, pH, temperature, additives). Hydrophilic peptides are soluble in aqueous solution attenuated with pH. Hydrophobic peptides are difficult to dissolve, and some organic solvents and/or additives are required to dissolve these peptides.

Endotoxin

Endotoxins are small bacterially-derived hydrophobic lipopolysaccharide (LPS) which can contaminate peptide product and underline process environments. The Endotoxin level (EU/mL) is determined by the standard Biochemical Assays

Stability

The stability of peptides greatly depends on peptide sequence as well as the process and storage conditions. Many peptide degradation processes are from Hydrolysis, Deamidation, Elimination, Oxidation, Racemization, Isomerization, DKP and pGlu/pAsp formation, Fragmentation, etc. The ideal peptide storage condition is at -20 o C. The stability studies profile of the peptide is designed, executed, monitored and documented by QC and production staff.

Bioburden Test

Bioburden test shows the unit counts of viable microorganisms in peptide product, and is important quality attribute in cGMP peptide production. Bioburden count is determined by the standard assay according to United States Pharmacopeia (USP) references.

 
 
 

[Pharmaceutical Peptide Field]

KareBay currently manufactures Peptide API’s for both pharmaceutical and biotechnology companies in multiple clinical studies:

Ophthalmology
Obesity

Growth Impairment

Allergy/Asthma
Hemopoiesis
Diabetes
Epilepsy
Osteoporosis
Cancer
Gynecology
Analgesia
Arthritis
CNS Disease
Alopecia
Antiviral
Vaccines
Antibacterial
Inflammation
GI Disease
CV Disease
 
 
                                                     

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