Custom Peptide Synthesis Services
KareBayTM Biochem is a global leading biotech CMO focused on providing customers with custom & catalog peptides, GMP/GLP grade peptides, and peptide library for research and pre-clinical applications. KareBay has a seasoned manufacture team, and our quality department performs the rigorous quality management to assure the conformity of the product and the process. KareBay’s scientists are experienced in peptide manufacturing and research, such as solution phase/solid phase synthesis, custom peptide synthesis, peptide combinatorial chemistry, peptide modifications, peptidomimetics, enzyme substrate design and synthesis, unusual amino acid design and synthesis, and other proteomic entities.
KareBay has full peptide therapeutics development capacity (Pharmability) under its state of the art process facilities, supported by its formulation optimization platform and cGMP quality system. KareBay has already developed broad experience in pharmaceutical peptide field, which includes than 60 peptide APIs and Inhibitors at various stage of trials (See Product list). KareBay can not only partner with big pharma to develop new peptide therapeutics and API, but also can provide biotech enterprises and academic institutes with strategic technical collaboration in their peptide research projects. With its experienced manufacture management team, KareBay has a great advantage in cost, quality, and lead-time control over its competitors due to its technical proficiencies, efficient integrated operation systems (Business development, Customer support, Quality, Production, and Supply-chain). KareBay welcomes all customers and partners from universities, research organizations, pharmaceuticals, biotech and everyone in need of peptide research and custom peptide synthesis services.
Personnel
Quality
Diversity
Pharmability
Speed
Cost
Personnel
KareBay has a very strong technique team comprising of 15 senior scientists who are experienced in the fields of peptide, fluorophore, medicinal chemistry, bioconjugation and polymeric chemistry and purification, bioassay, QC/QA. Up to date, our chemists have produced thousands of peptides, and KareBay is capable of t-Boc, Fmoc, Cbz, solid phase synthesis, solution phase synthesis, fragment condensation as well as ligation chemistries. At KareBay, our scientists can easily handle complicated conjugations and are experienced in stabilizing, optimizing and analyzing the conjugates. Director of Peptide Chemistry has more than 20-year experience in fluorophore, medicinal and peptide chemistry. And more, Dr. Drew Dai, is a senior polymeric/peptide and bioconjugation chemist, with more than 10 years of bio-reagent development experience.
KareBayTM Featured Services
KareBayTM Biochem provides comprehensive services on custom peptide synthesis for your peptide-based researches and business. Our operation mission is to provide our customers with the best proteomic services in terms of Cost, Quality, and Delivery time. Briefly go through our featured services or click to specific pages on each service to explore our comprehensive and flexible packages.
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KareBayTM Biochem
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Purity
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Crude to >98%
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Crude to >98%
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per request
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Quantity
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mg to gram
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1-25 mg
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gram to kg
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Length
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2-190 amino acids
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5-30 amino acids
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per request
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HPLC, MS and LC-MS
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HPLC, MS and LC-MS
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Multiple Reports according to GMP
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Turnaround Time
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from 2-3 weeks (
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from 2-3 weeks
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per request
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Trusted Quality by KareBayTM
KareBayTM Biochem has developed and established full quality management system to assure the conformity of peptide products, and the underline standard operation processes including raw material controls, synthesis, purification, quality control, packaging, shipping, and customer complaints. The conformed peptide product is certificated with the standard COA document (Certificate of Analysis). We also offer other customized quality control testing per specific request. Briefly know our comprehensive quality certificates list or explore detailed information, including sample reports, on Quality Certificates page:
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Default
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Available
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per Request
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Quality Certificates
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Non-GMP Grade
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cGMP Grade
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HPLC Trace
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Purity by gradient HPLC
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Mass Spectrometry
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MW by ESI-MS
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LC-MS
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Amino Acid Analysis (AAA)
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Peptide Content
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Water Content
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Counter Ion Content
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Residual Organic Solvent Content
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Appearance
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Solubility
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Endotoxin
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Stability
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Bioburden Test
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(1)Non-GMP research Peptides
KareBay has a strictest quality control system. KareBay typically characterizes non-GMP peptides with reverse-phase HPLC, LC-MS; HNMR and CNMR for higher complexity (i.e. stereo-chemistry) of the target compound and element analysis for high purity of target compound.
(2) cGMP peptides
KareBay requires a high degree of certainty regarding analytical purity and identity of each drug substance (each peptide), related substances (truncated, deletion, de-amidated sequences) and residuals such as solvents, water and counter-ion. KareBay’s team has experience developing, optimizing, and validating analytical systems for complex peptide vaccines. A typical non-USP or EP grade GMP peptide is tested in KareBay with following specifications: ? Appearance ? Solubility ? Purity by gradient HPLC ? Molecular Weight by ESI-MS ? AAA ? Peptide content ? Counter ion content ? Water content ? Residual organic solvent content ? Endotoxin ? Stability, as requested ? Bioburden test, as requested ? Specific Rotation, as requested ? Other tests, as requested A dedicated QA/QC department guarantees full cGMP compliance throughout production, as well as testing and documentation standards in accordance with the strictest FDA requirements. KareBay has developed and maintained a robust quality assurance system covering all aspects required for the cGMP production of peptide APIs. Customers audit can be conducted whenever they deem necessary. Starting raw materials vendors are carefully evaluated by our QA department and must provide a BSE free certificate. We provide complete support for your IND and NDA fillings whether they are documentation or experienced QA staffs. Continued regulatory assistance is provided by KareBay throughout any project to make sure that our developments fit with the customers’ requirements. This includes timely filing and updates of DMFs or CMCs as required.
Chemistry Diversity
KareBay is technically versatile in synthetic organic chemistry. Experienced chemists here have constructed many challenged peptide production projects with special amino acids and many other modifications. We have developed and patented conjugated peptide substrates to help our customer’s studies in biological processes. Switch to Chemistry Diversity specific page to explore detailed information.
Common Peptide Modifications
Enzyme Substrates
FRET based substrates
C-terminal modified substrates
Self-quenched substrates
Unusual Amino Acids or Other Chemical Entities
Pharmability
Facility and Production Capacities
KareBay owns 4 independent production units, with 10 liter, 30 liters and up to 200 Liters solid phase Capacity. Purification and lyophilization are performed inside Clean Rooms at class of 100,000, 10,000. With our experience and technical capacity, we can quickly scale up to gram or kilogram levels.
cGMP
KareBay manufactures GMP grade peptides under strict adherence to FDA 21 CFR parts 210 & 211 and conforms to ICH Q7A Good Manufacturing Practices. We welcome any of our customers to inspect or audit our cGMP facilities. To inquire about our GMP service, please contact us for details.
cGMP Peptide-based Cancer Vaccine Manufacturing Services:
Learn More…
Our team at KareBay has manufactured numerous peptide APIs and cGMP grade peptides for industry enterprises and academic research groups over years. Our production experience also includes naked antigenic sequences of varying lengths, single antigens, Multi-Antigenic-Peptides (MAPS), peptide conjugations to KLH, and multiple peptide vaccine cocktails.
Research GMP (GLP):
Learn More…
KareBay has been developing inhibitors at various clinical trials rapidly and at the lowest possible cost for academia, pharmaceutical, and biotech companies. At your request, we will provide research-grade peptides for your pre-clinical in-vitro, medicinal and toxicology programs. This service will provide you with milligrams to multi-grams of research-grade peptides fully-qualified and released by our in-house Quality Control Department. We can perform solid-phase, solution-phase or hybrid peptide chemistry plus organic conjugations to proteins, toxoids, antifungals, KLH, and PEG.
Formulation
Regulatory
SOPs, Documentation, and KareBay’s history with FDA will be important to the value of your IP after collecting human data. We can assist in filing INDs and are prepared to file a DMF at the appropriate future opportunity.
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 |
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| Antiviral |
Vaccines |
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| Antibacterial |
Inflammation |
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| GI Disease |
CV Disease |
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KareBay can deliver custom peptides released by our in house Quality Control Unit in as little as 2-3 weeks.
KareBay’s unique business model provides us with the ability to produce quality products at a price lower than most competitors.
Manufacturing most of the key raw materials, including unusual amino acids, special amino acids derivatives, modified resins and other chemical intermediates
Global operation to minimize other costs
Lowest cost of manufacturing with either solution or solid-phase synthesis under fully controlled cGMP system with seasoned management
How to get started
If you have any other enquiries, please leave a message.
Please
click here to fill online order form, and we will make sure to supply you quote as soon as possible. Alternatively you can also download our order form in excel file and send us at
service@karebaybio.com. This process usually takes between 24 to 48 hours. The quote will include an estimated price as well as the time required to complete the project. All inquires and subsequent projects are handled in the strictest confidence and will be backed by a confidentiality agreement if required.
