Case Studies

Primecore has an established track record of addressing some of the most complex challenges you may be facing. Read how our services have made a difference in these success stories.

Product Program Management

Providing Program Management for a Phase 3 CMC Program

The client required the development of an integrated program approach for a schedule driven Phase 3 program. There were several key workstreams such as process development, tech …

CMC Package for Phase II Regulatory Submission

The client was a small, cell therapy company developing a novel patient-specific immunotherapy vaccine for cancer. The FDA placed the company on clinical hold pending submission of …

Biopharma Portfolio Management

A client was struggling to retain control of a complex and ‘evolving program’. There was a general lack of clarity in terms of how the program was …

Network and Supply Strategy

Realizing Asset Full Potential through Operations Best Practices

A leading Gene Therapy organization had a significant pipeline of high potential pre-clinical and clinical assets. While the assets were mature from a research perspective, they had …

Developing Pharmaceutical Product Strategies for Operations

Following a major acquisition that more than doubled the product portfolio, the client wished to create product operation strategies for their commercial and pipeline products. Primecore was …

Translating the Business Requirements into a Manufacturing Strategy

For companies transitioning from the early clinical phase to late phase clinical and commercial launch, a clear manufacturing and CMC strategy is critical. The client requested Primecore’s …

Capital Program Management

Leading a Business Critical Capital Project for API Production

Primecore was approached by a biologics company to review the status of a ‘business critical’ capital project which was in the early stages of execution – the …

Auditing a $2.1B Capital Project for the Board of Directors

A significant capital project had been re-baselined, following a Monte Carlo risk assessment, which resulted in a significant increase in the project budget and timelines. As a …

Capital Projects in Support of Two Gene Therapy Programs

The client requested that Primecore assume leadership of a strategic project which enabled two strategically important programs, one to produce material to support a Gene Therapy Phase …

Operations and Continuous Improvement

Development and Deployment of Manufacturing Accounting Model

The client is a multinational, biotech company with manufacturing facilities around the world. Each facility had a complex mix of processes at different stages of production and …

Deploying Pharmaceutical Operations Strategy

The client was a mid-size pharmaceutical company based in the EU but had a global manufacturing network. The assignment was to identify the optimum API network of …

Developing a Capital Program for Maintaining Assets

Traditionally companies have struggled in their attempts to determine the appropriate level of capital needed to invest in a site in order to ensure that it operates …

Capacity Modeling of a Manufacturing Network

Following a major acquisition which more than doubled the client’s product portfolio, the client wished to consolidate its legacy network capacity planning models. The client desired a …