Proven Intelligence Accelerating Next-Generation Therapies.

Executive Summary

For US-based sponsors of viral vector programs, managing GMP manufacturing at European facilities introduces significant logistical and regulatory complexity. Franklin Biolabs provides dedicated Person-in-Plant (PIP) scientific oversight and technology transfer services to bridge this gap. We ensure your process, analytics, and manufacturing strategy are correctly implemented at your chosen EU CDMO, de-risking batch execution and supporting Investigational Medicinal Product Dossier (IMPD) submissions for Advanced Therapy Medicinal Products (ATMPs). Our approach is built on the scientific lineage of the UPenn Vector Core, providing continuity and deep technical expertise to accelerate programs toward clinical readiness within an 18-24 month timeline.

Aligning US-Based Science with European GMP Execution

Executing a GMP manufacturing run for a novel viral vector is a complex undertaking. When that run occurs at a European facility while the core scientific team is based in the United States, the potential for process drift, miscommunication, and costly deviations increases substantially. A successful campaign depends on active, expert scientific management on the ground to ensure process integrity.

Franklin Biolabs provides this layer of technical oversight. Our service is designed for sponsors who need to ensure their scientifically-grounded process is not lost in translation during manufacturing. We act as a direct extension of your team, present at the facility to manage the technology transfer and oversee the execution of GMP manufacturing steps.

A Framework for Manufacturing Readiness

Our approach begins long before the first GMP suite is booked. We conduct a thorough gap analysis of your existing process and analytics, identifying potential failure points and areas that require reinforcement for scalable manufacturing.

This readiness framework includes:

• Process & Analytical Gap Analysis: A systematic review of your current manufacturing process and analytical methods to confirm they are robust and suitable for GMP implementation and validation.

• Technology Transfer Management: We assemble and manage the complete technology transfer package, ensuring all necessary documentation and process knowledge is clearly communicated to the receiving manufacturing site.

• On-Site Oversight: Our scientific expert is physically present during key phases of the manufacturing campaign, from cell expansion and transfection to purification and fill/finish, providing real-time problem-solving and decision-making.

• Batch Record Review & Deviation Management: We provide rigorous review of all executed batch records and offer scientific guidance on the investigation and resolution of any manufacturing deviations.

“We started collaborating with UPenn Vector core in 2023 and the AAV vector which they manufactured laid a foundation for development of a gene therapy candidate which will enter soon preclinical studies. The key people from UPenn Vector Core joined Franklin Biolabs and our partnership transitioned without interruption from UPenn Vecor Core to Franklin Biolabs Research Vector Division. Franklin Biolabs is our key scientific collaborator in our AAV-vector based gene therapy candidate development and we hope to continue the partnership for years to come.”
— Biotech Partner

Connecting Process Integrity to Clinical Viability

A well-controlled manufacturing process directly impacts the viability of a therapeutic candidate. The ability of a vector to achieve a sustained therapeutic effect, as demonstrated in preclinical models (PMID: 12134142), is contingent on producing a consistent, high-quality product. This consistency is the primary goal of our GMP oversight.

Understanding factors like pre-existing neutralizing antibodies in the global population (PMID: 19133809) also informs vector selection and dose justification. This strategic consideration must be connected to a manufacturing process capable of producing the required vector at sufficient scale and purity, a link we help solidify for our clients’ programs. Our >100,000 sq ft of integrated analytics and in vivo study space provides the foundation for this work, which has contributed to a 100% successful IND rate for programs we have supported since 2019, prior to the Franklin Biolabs brand launch in 2024.