Built for Continuity IND to BLA
CGMP clinical manufacturing from Phase I through BLA, one team, one facility, fully US-based.
Value
Advance Your Program
with Confidence
Consistent from phase I to BLA
Manufacturing approaches and quality systems remain aligned across every clinical phase, supporting continuity as your program evolves.
Scaled for every milestone
From early clinical supply to pivotal trial manufacturing, infrastructure and expertise grow with your program.
Data that supports approval
Each batch contributes to the manufacturing history, comparability, and validation data required for BLA submission.
Integrated
execution
Manufacturing, quality, analytics, and regulatory support work together as one coordinated program.
DEVELOPMENT
One Standard of Quality, Every Phase
Phase I , First-in-human supply
Small-scale CGMP batches supporting safety studies, with strong documentation and IND compliance from the start.
Phase II , Expanding clinical supply
Increased production to support broader studies, with process refinement and comparability aligned to program progression.
Phase III , Pivotal trial manufacturing
Large-scale manufacturing supporting pivotal trials, with consistency and process characterization aligned to BLA requirements.
BLA Support , Approval readiness
Process validation, comparability, and documentation supporting regulatory submission and inspection readiness.
SOLUTION
Scale that Grows
with Your Program
Up to 2,000L clinical manufacturing
Avid’s bioreactor infrastructure supports clinical manufacturing from early-phase batches through large-scale pivotal trials at up to 2,000L.
Because clinical and commercial manufacturing are connected within the same system, your process scales within a consistent environment, supporting continuity as your program advances.
Our Process
Clinical Manufacturing Capabilities
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01
CGMP manufacturing
End-to-end manufacturing campaigns from seed train through purification and bulk drug substance production.
-
02
Release & stability testing
Validated testing and ICH-compliant stability programs supporting clinical use and regulatory submission.
-
03
Bulk packaging
Controlled packaging, labeling, and storage preparing drug substance for downstream use.
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04
Regulatory support
CMC documentation for IND amendments, annual reports, and BLA submissions.
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05
Technology transfer
Structured transfer of processes and analytical methods when programs transition to Avid.
APPROACH
One Program.
Continuously Advancing.
Every manufacturing campaign builds on the last, strengthening process understanding, analytical insight, and quality consistency.
This continuity supports efficient progression through clinical phases and into BLA submission, with a program that evolves as a cohesive whole rather than a series of disconnected steps.
WHY US
Credibility at a Glance
30+ Years: Biologics manufacturing expertise
2,000L: Clinical manufacturing scale
100% US-Based: Orange County, California
FDA Experience: Inspected facilities with commercial approvals
Why Us
Why Avid Bioservices
One Team from IND to BLA
Continuity across clinical manufacturing and regulatory preparation.
Scalable Infrastructure
From early-phase batches to pivotal trial manufacturing within the same system.
FDA-Experienced Quality Systems
Proven processes supporting regulatory submissions and inspections.
Integrated Capabilities
Manufacturing, analytics, quality, and regulatory support aligned under one organization.
US-Based Operations
Domestic manufacturing supporting regulatory alignment and supply chain reliability.
Pathway to Commercial
Seamless transition from clinical manufacturing to commercial supply.
Advance your program to BLA
Tell us where you are in development. We’ll help you move forward with consistency, scale, and confidence.
Learn More
IND to BLA FAQs
Phase I manufacturing supports first-in-human safety studies with smaller batch sizes. Phase II expands production for broader clinical studies and process refinement. Phase III involves larger-scale manufacturing for pivotal trials, generating data that supports regulatory approval.
Process validation demonstrates that a manufacturing process consistently produces drug substance meeting predefined quality specifications. It typically includes process performance qualification (PPQ) runs and supporting characterization data.
Technology transfer is the structured process of moving a manufacturing process between facilities or organizations, including transferring process knowledge, analytical methods, and documentation to ensure consistent performance.
Release testing confirms identity, purity, potency, and safety using validated analytical methods under CGMP conditions before a batch is approved for clinical use.
US-based manufacturing supports alignment with FDA expectations, simplifies logistics, and can be important for regulatory, funding, and supply chain considerations.
Yes. Avid supports programs through commercial manufacturing, maintaining continuity of team, process, and quality systems.