Our drug development continuum

As your go-to CMO for custom peptides, AnaSpec manufactures a range of peptide grades for use in basic research applications, up to GMP peptide API for Phase I clinical trials.

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Grade Continuum

From research grade peptide to GMP API for Phase I clinical trials

High Flexibility

We follow the most appropriated manufacturing process according to your application

Adapted Quantity

We can produce from milligram to hundreds of gram quantities

High Quality

From basic purity/identity QCs, up to a large QC panel including peptide API purity and impurity quantitation

Comprehensive Documentation

We provide certificate of analysis and documents related to Chemistry, Manufacturing and Control (CMC package)

Valuable Support

Our team of experts will be at your side from the beginning of your project to its completion.

GMP Peptide Manufacturing Service

Our GMP team will guide you from the initial project discussions, to completion of your GMP peptides.

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).

ISO 7 Cleanrooms

Highly controlled ISO 7 classified cleanroom (10,000) environments

Environmental Monitoring

Weekly microbial testing with nonviable sampling of cleanroom

Security

Restricted access cleanroom entries with airlocks for security and process control

Qualified staff

State-of-the-art equipment and exceptionally qualified staff.

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
Analytical Methods
Certificate of Analysis
Change Control Notification
Product Specification
Incoming Raw Material Specification & Testing
Expiry or Retest Date
Supplier Qualification
Identification of Critical Process Parameters
Batch Manufacturing Record & Review
Lot Sample Retained
Dedicated Project Management
Classified Clean Room ISO7 (10.000)

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