Effective planning and thorough consideration are essential to identify and mitigate any potential delays or inefficiencies in your pharmaceutical tech transfer process. By selecting the right partner to entrust with this process, you can proactively address any challenges and minimize their impact to ensure your project reaches patients as planned.
A successful pharma tech transfer project requires solid scoping, planning and execution. When it comes to the tech transfer of sterile injectables, there are special considerations to factor in on the path to market.
Dive into our playbook - the ultimate guide to tech transfers in the pharmaceutical industry. A dynamic and robust approach to tech transfers is essential, especially when outsourcing pharmaceutical production to CDMOs.
Dr. Martin Gonzalez, Senior Manager at PfizerCentreOne Technical Services, outlines the steps that must be carefully considered.
Pfizer CentreOne’s sterile injectables experts discuss the three phases of a technology transfer on a sterile injectable project, covering how to bridge information gaps and facilitate the path to successful regulatory filing at this fundamental stage of drug development.
Ensuring successful market entry means going beyond securing manufacturing capacity. As your pharma tech transfer partner, we possess a deep understanding of your campaign’s landscape, including regulatory filings, compliance, global scalability, supply chain integrity and data security.
Harnessing the right technologies goes further than using the latest bioreactor or spray dryer. We prioritize your tech transfer needs by identifying and leveraging economies of scale while placing utmost emphasis on safety and sustainability.
With a deep understanding of your project’s unique requirements, we are dedicated to offering sturdy, dependable and validated processing capabilities that consistently yield superior quality outcomes for the patients you serve.
We ensure that the right people are brought into your project at the right time to successfully manage your pharma tech transfer process. Our talented professionals possess adept project management and operational skills paired with strong scientific expertise to help keep your project on track.
By taking a proactive approach to regulatory compliance, we harmonize your dossier requirements for multiple markets, provide strong cGMP manufacturing operations, and ensure effective documentation and data management. Our established relationships with global regulatory bodies and comprehensive understanding of their requirements allow us to help you get your medicines over the line to the patients who need them most.
Dr. Martin Gonzalez is a Ph.D. in biophysical chemistry and has extensive experience in the pharmaceutical industry with over 25 years of specialized expertise in a wide range of biologics, including plasma-derived proteins, polypeptides, enzymes, vaccines, and recombinant proteins and antibodies.
With this expertise, Dr. Gonzalez has made significant contributions to the development of formulations and manufacturing processes for a range of biologics and synthetic drug products.
In 2013, Dr. Gonzalez joined Pfizer CentreOne at its McPherson, Kansas facility where he leads and authors all technology transfer activities from customers to sites across the Pfizer network. His wealth of experience has established him as a subject matter expert in critical areas such as protein formulation, product development, lyophilization, manufacturing troubleshooting, delivery devices, and final container selection.