Unlock the assurance of quality with our Biologics Lot Release Testing service! Dive into the details of our biotech expertise at Green Biotec Biologics Lot Release Testing – where precision meets excellence.
Lot Release Testing for Biologics:
When preparing a biologic for market launch, drug manufacturers face the critical challenge of gathering and reporting essential data to regulatory authorities. Among the crucial data requirements, the selection, qualification, and validation of appropriate lot release methods play a pivotal role in reflecting the safety and quality of the product.
In the drug manufacturing process, bulk harvest samples are collected at the end of production before downstream activities. These samples are rigorously tested to ensure the absence of contaminants from the production process.
Once contamination is ruled out, the drug substance and final product can be processed further. Lot release testing at these final stages is a mandatory regulatory requirement for all marketed products, confirming the identity, purity, and potency of both the drug substance and the final drug product.
Comprehensive Support for Your Biologic Development Program:
At Green Biotec, we offer a unique suite of integrated services designed to support your biologic development program from the early stages of cell line development to commercial batch release. Our proactive approach includes:
- The development of early-phase characterization assays.
- Anticipating future qualification and validation needs.
- Ensuring a smooth analytical development process that prevents costly delays later on.
We guide you in selecting suitable lot release methods and performing phase-appropriate GMP qualification and validation. Combined with our fully compliant biosafety assay portfolio, Green Biotec helps you generate the necessary data to establish specifications and facilitate the efficient release of your product.
Bulk Harvest Testing: Ensuring Purity:
Bulk Harvest Testing is a crucial step in biologics manufacturing, performed just before downstream purification. This stage involves a battery of tests, which may vary based on the product and regulatory guidelines but typically include:
- Sterility testing
- Mycoplasma testing
- In vivo assays
- In vitro assays
- Retrovirus assays
- Bovine and porcine assays
- Electron microscopy
- Species-specific assays
The results of bulk harvest testing guide decisions on viral clearance studies and additional testing requirements for the drug substance. Quick turnaround is essential, as production can only proceed once batch contamination is confirmed as absent. To expedite testing, Green Biotec offers streamlined reporting of results and suggests alternative assays that meet regulatory requirements while saving time.
Testing Drug Substance & Drug Product
The drug substance (unformulated active ingredient) and drug product (formulated drug) must undergo testing to confirm identity, purity, and potency. Green Biotec provides a wide range of analytical testing methods, including:
- Identity testing may include specific PCR tests, sequencing analysis, SDS-PAGE, and restriction enzyme analysis.
- Purity and impurity testing to confirm the absence of product- and process-related impurities. Orthogonal methods are employed for a comprehensive impurity profile.
- Process-related impurity testing to ensure controlled manufacturing processes.
- Potency testing involves quantitative measurements of biological activity calibrated against a reference standard. Assay types vary based on the product’s mechanism of action.
Green Biotec also offers additional tests to fully characterize the final drug product, such as sterility testing, appearance assessment, pH measurement, osmolality testing, titer determination for viral-based products, endotoxin testing, and extractable volume analysis.
Qualification & Validation: Ensuring Quality
The improvement, qualification, and validation of analytical assays are fundamental to generating tremendous merchandise successfully. Qualification studies help establish the parameters indicating whether or not an assay has worked. There aren’t any predefined popularity criteria, only performance capability requirements primarily based on the meant application. Depending on your improvement segment, assays may be qualified for GMP or non-GMP requirements.
Validation, always in compliance with GMP, demonstrates consistent assay performance. Each validation run must meet predefined criteria, and any failures require investigation and resolution before considering the method fully validated. Green Biotec tailors studies to meet regulatory guidelines and your development phase, providing cGMP-qualified assays for clinical batch release or fully validated assays for Phase III and final regulatory submission.