AmplifyBio’s mission is to deliver Quality Control services that ensure the highest safety, efficacy, and reliability standards in our clients’ manufacturing processes. We are committed to providing comprehensive analytical support, innovative testing solutions, and rigorous environmental monitoring, all tailored to meet the unique needs of each product’s life cycle.
AmplifyBio’s Quality Control services ensure the highest standards of safety, purity, and potency for advanced therapies such as cell and gene treatments. Utilizing state-of-the-art analytical and microbiological testing methods, we provide comprehensive product characterization, in-process monitoring, and rapid sterility testing. Our GMP-compliant laboratories and expert team work closely with clients to streamline regulatory submissions and maintain rigorous quality throughout the product lifecycle, ensuring that every therapy meets stringent compliance requirements.
AmplifyBio operates a comprehensive, modernly equipped Quality Control (QC) laboratory facility at its AMEC site, designed to support our clients’ manufacturing processes. These operations encompass environment and utility monitoring, in-process and final product testing, raw material qualification and release testing, as well as stability studies. Additionally, the QC team is able to provide extensive analytical support through custom method development & optimization, qualification, and validation of analytical procedures suited to phase-appropriate product life cycles. These procedures can be developed in-house, fully customized to client specifications, or transferred directly from the client. Our methodologies accommodate many modalities, including Cell therapy, Gene therapy, mRNA, plasmids, and more.
In addition to QC’s analytical-related functions, each site has a centralized sample management group, with validated storage chambers covering the full range of temperatures: liquid nitrogen vapor phase, -80°C, -20°C, refrigerated, and room temperature. A validated electronic monitoring and alarm system monitors the temperature of all chambers 24/7.
| Testing Requirements | Supporting Methodologies |
|---|---|
|
USP Compendial Testing |
Bioburden [61] Endotoxin [85] Conductivity [645] Osmolality [785] Visual Inspection and Appearance [790] pH [791] |
|
Sterility |
Rapid Sterility via BacT/ALERT |
|
Mycoplasma |
PCR-based Rapid Detection via Quantitative PCR |
|
Cell product characteristics profile, Immunophenotyping, Immunomonitoring |
Flow Cytometry |
|
DNA, RNA, and Protein
Quality and Purity
|
Capillary Gel Electrophoresis, HPLC, Traditional Gel Electrophoresis |
|
Impurity & Targeted Protein Quantitation |
Immunoassays by Automated or Traditional ELISA,
Microplate-based absorbance, fluorescence, luminescence and HTRF analysis |
|
Viral copy number, Viral Genome Titer, Viral Clearance, Residual DNA impurity quantitation |
Real Time Quantitative PCR (qPCR), Digital PCR (dPCR), Digital Droplet PCR (ddPCR) |
|
Bioactivity / Biopotency Assays |
Custom methodology on a per client, per product basis |
|
Sequencing |
Traditional Sanger Sequencing, NGS, RNASEQ |
|
Complete Blood Count Analysis |
Automated Hematology (CBC) Analyzer |
Phase 1 of the 350,000-square-foot manufacturing facility includes standalone B- and C-grade suites that can be configured to accommodate any modality and simultaneously produce multiple lots. The manufacturing suites are complemented by quality, process development, and expansive analytics laboratories staffed by experts at AmplifyBio to ensure that clients have access to a development “sandbox” of assay platforms, technologies, and expertise anchored in experienced GMP quality assurance and facility management.
Comprehensive service programs for the development of Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial. Offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing available in an integrated, innovation-rich environment that goes beyond the value proposition offered by traditional CDMO and PDMO contract models.
