From research grade peptide to GMP API for Phase I clinical trials
We follow the most appropriated manufacturing process according to your application
We can produce from milligram to hundreds of gram quantities
From basic purity/identity QCs, up to a large QC panel including peptide API purity and impurity quantitation
We provide certificate of analysis and documents related to Chemistry, Manufacturing and Control (CMC package)
Our team of experts will be at your side from the beginning of your project to its completion.
Learn more about our GMP service options and meet key members of the team.
Confidential Disclosure Agreements (CDA)’s will allow two-way communication about your project.
We’ll perform a project assessment, provide the price quotation and complete Master Supply and project agreements.
We offer process development services to define the GMP manufacturing process parameters specific to your custom peptide.
Feasibility small scale pilot run is performed for complex GMP peptide orders and/or as needed. The feasibility pilot run is used to identify the in-process controls (IPCs) that are critical for a successful GMP campaign. In addition, the feasibility pilot run will be used to identify the most suited upstream and downstream manufacturing conditions to ensure products high quality and yield.
Engineering run is performed at-scale to mimic a GMP manufacturing batch. The Engineering run is used to identify most suitable scale up conditions and to further define process parameters and is available upon request.
GMP peptide manufacturing is performed in our state-of-the-art facility using qualified equipment and highly trained staff. Our upstream and downstream areas, are completely segregated with limited access for complete process control and security.
The upstream rooms are dedicated to GMP synthesis and cleavage processes. Our highly controlled ISO 7 classified (10,000) downstream cleanroom environments are dedicated to GMP purification, lyophilization and packaging operations.
Our GMP manufacturing implements robust in-process controls to assure a successful GMP campaign with final product that exceeds pre-established specification and requirements.
We follow a full set of SOPs and thoroughly document each process in batch production records that are archived for 5 years, with the possibility to provide redacted batch records.
Anaspec offers phase appropriate analytical method validation and/or full analytical method validation for its customers according to products clinical phase.
AnaSpec is currently supporting its GMP customers with real time stability programs. The stability programs utilize validated storage chambers, both @-20±5̊℃ and 5±3̊℃ storage conditions and are continuously monitored by the state of the art calibrated temperature data loggers. )
AnaSpec supports its GMP customers with IND filling by providing documents related to Chemistry, Manufacturing and Control (CMC package).
GMP Peptide Specifications
By extending our long-standing RUO custom peptide expertise to GMP peptide Manufacturing, we combine innovation with GMP grade reproducibility, traceability, and consistency. We provide flexible batch sizes from small scale to large scale manufacturing including synthesis, purification and lyophilization up to tailored QC releases.
|Attributes||Research Grade||GMP Grade|
|Product Applications||Research & Discovery||API Drug Substance | BioPharma Processing | Excipients|
|Quality Systems Controls||ISO 9001||ISO9001 | compliant with parts of 21 CFR part 210 & 211|
|Service Agreement / Audits||Standard|
|Certificate of Analysis||✓||✓|
|Change Control Notification||✓||✓|
|Incoming Raw Material Specification & Testing||✓|
|Expiry or Retest Date||✓||✓|
|Identification of Critical Process Parameters||✓|
|Batch Manufacturing Record & Review||✓|
|Lot Sample Retained||✓|
|Dedicated Project Management||✓|
|Classified Clean Room ISO7 (10.000)||✓|
Our GMP grade peptides are manufactured under a comprehensive quality management system compliant with 21 CFR 210 and 211 and ICH Q7 guidelines applicable for GMP API early clinical phases.
QC Testing Attributes
Our GMP testing follows a stringent QC process according to pre-established product specifications determined with our customers, which identify the attributes and their acceptance criteria. We systematically check the basic peptide properties such as identity, appearance, and purity in addition to large range of validated QC methods including enantiomeric purity, peptide sequencing, water content determination, endotoxin and bioburden measurement, solubility testing and counter-ion content, among others.
30 years of expertise
One of the key foundations of our services is unparalleled talent and a dossier of peptide manufacturing capabilities achieved only through years of real-world experience. Our scientific team is comprised of experts in the fields of peptide technology, fluorescence technology and combinatorial chemistry. We specialize in complex modified peptides, dye-labeled peptides, and hydrophobic peptides. In addition to GMP peptide synthesis and purification services, we also offer stand-alone GMP dyes.
GMP peptide applications
In addition to use as API drug substance for phase I clinical trials, our GMP peptides may also be applicable to other uses including as Cosmetic ingredients, Biopharmaceutical processing starting materials, QC Standards, or Pre-clinical animal studies.