Cell & gene therapies are transforming medicine and creating options where none previously existed. But advancing a CGT program to patients requires navigating a uniquely unforgiving path: evolving global expectations, accelerated pathways with heightened scrutiny, and manufacturing realities where small changes can have outsized impact. Comparability constraints, potency and analytical complexity, aseptic processing, and chain-of-identity/chain-of-custody controls make “standard” CMC playbooks insufficient, and a single misstep can cost critical time, product, and momentum.
Pharmatech Associates, a USP company, partners with you to build an integrated, phase-appropriate approach across CMC, quality systems, and regulatory strategy. We help you define risk-based control strategies, strengthen GMP readiness, and create regulator-ready submissions grounded in practical manufacturing execution, from process and analytical development through tech transfer, CQV readiness, and inspection preparation. Our goal is to help you reduce avoidable rework, maintain a consistent state of control, and move confidently through development, so life-changing therapies reach patients faster.
Unlike traditional biologics, cell and gene therapies often lack clear regulatory precedent. Success requires anticipating agency expectations and building the right systems early.
What you gain with Pharmatech:
A CGT client needed to manage five programs submitted under the biologics framework. We helped overhaul quality systems, update regulatory documentation, and redesign facilities.
Impact for the client:
✔ Zero FDA observations during surveillance audit
✔ Facility redesign completed for compliance and scalability
✔ Full QMS remediation and IND updates delivered
A CGT CDMO needed to transfer manufacturing and analytical methods for eight unique products. We conducted risk assessments, developed protocols, and created master batch records and SOPs.
Impact for the client:
✔ Successful tech transfer for all eight products
✔ Regulatory alignment maintained throughout
✔ Downtime minimized, operational continuity ensured
Cell and gene therapy development requires CMC strategies that can adapt to evolving regulations and complex biology. We help you design integrated control strategies that reduce risk, strengthen compliance, and support long-term commercialization.
Our focus areas include:
Bringing a CGT product to market requires precision, speed, and expertise. Pharmatech Associates works with you to overcome regulatory, technical, and operational barriers so you can deliver therapies that change lives.
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
1.877.787.0177
510.732.0177
Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583
