Cell & Gene Therapy

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 supporting a commercial drug product 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.

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. 

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.

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.  Learn more about our perspective here.

Launching a new drug product, or leading your organization through transformational change, requires experienced program leadership to help you meet your goals. Point B has been working with our clients for 25+ years to help them solve their most difficult challenges. Our experience building and leading enterprise PMO's for our cell and gene therapy and life science clients, using our proven agile capability building approach, accelerates the ability of our clients to respond to the challenges of major initiatives. From enterprise system implementations to global drug product launches, we work with you to build and execute your program with the right resources at the right time.

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. We help our clients prepare in a variety of ways, including inspection readiness assessments, deviation and CAPA reduction management, planning for mock inspections and dress rehearsals with 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.