At Point B, supporting patients and the people who create life-saving therapies are at the heart of our Cell and Gene Therapy work.

Point B’s Cell and Gene Therapy solutions help you optimize your people, processes, and technology investments, build critical capabilities and maximize your operational efficiencies to enable your organization to focus on bringing lifesaving therapies to patients.

Our Expertise

Maximizing your commercial success, Cell Therapy Transition to Commercial

Autologous cell and complex allogeneic therapies require more integrated and scalable approaches than traditional pharma to support the people, processes and technology needed to produce these life-saving products. Point B brings the knowledge and a proven methodology to assess and manage transitions from R&D to Clinical and Clinical to Commercial. Point B’s Cell Therapy Operating Assessment focuses on customer-facing processes. By bridging clinical with future commercial processes, organizations can accelerate commercialization efforts and differentiate within the marketplace.

Integrated Cell Therapy Platform & Systems Roadmap

The build-to-order nature of autologous Cell Therapy products require a tightly integrated platform of systems that work seamlessly together to ensure the chain of identity and integrity of the final drug product.  Determining which systems and when to implement each is critical to your commercial success.  Along with that, it is critical to utilize program and project leadership with expertise in systems implementation and integration. Point B’s experience leading successful initiatives can help you establish the critical ecosystem required to develop and deliver cell therapy products. 

Launching a New Cell Therapy Manufacturing Facility

Moving from clinical to pilot to full scale manufacturing is tough in any Life Sciences segment but doing so in autologous therapies is particularly challenging.  CAR-T and other cell therapies require new facilities to transfer technology and processes from existing manufacturing, but also to introduce new capabilities that allow global manufacturing to scale effectively and profitably.  Point B has the experience in helping companies manage the gamut of Tech Transfer, Supply Chain, Construction / CQV, Quality, QC, and Operations projects throughout the lifecycle from breaking ground to regulatory filing to commercial launch.

Inspection Readiness

Preparing to successfully pass a regulatory inspection can be a lengthy and expensive process for an organization, with the company’s future roadmap at stake. Point B utilizes deep experience in helping our customers navigate inspection success through repeated inspection readiness assessments in three key areas: Inspection logistics and management; Audits, assessments and remediations of findings; and SME readiness through development of presentations and playbooks, and practice. The focus on planning, execution and improving in these three areas to support the results of the Point B assessments helps to prioritize the most critical vulnerabilities and biggest risk areas. 

Commercialization Readiness

Point B's hands-on experience launching multiple cell therapy drug products across three continents gives us a unique perspective. We know making the transition from clinical operations to commercialization can be very challenging. Launching globally multiplies those challenges. Point B's approach, utilizing an Operational Readiness Assessment framework, will help to prioritize those areas and functions needing additional focus. Point B’s methodology is executed at milestones along the commercialization roadmap to enable the organization to measure operational maturity and monitor risks to successful launch. Our approach covers functional areas across the manufacturing facility as well as operational functions across the company to ensure cross-functional procedures and processes are established and aligned.

Scaling to Meet Exponential Demand

Cell therapy has a unique opportunity to revolutionize personalized medicine, but it also has a unique challenge. How do you scale your operations to meet the growing demand of a custom, life-saving treatment? We understand that the real value to patients is accelerating the arm-to-arm value stream, optimizing turn-around-time, and delivering treatment in days, not weeks. We use a proven, holistic approach to eliminate inefficiencies and bottlenecks, create capacity, and increase speed of treatment delivery. We engage the entire organization responsible for developing, producing, and releasing product from Process Sciences, Supply Chain, and Manufacturing to Patient Operations and Quality.