Product life cycle management with a wide range of manufacturing assets
Leveraging more than 30 years of mammalian manufacturing experience we can provide you a comprehensive yet flexible development and manufacturing packages. We work with clients of all sizes, from small biotechs to multi-national pharmaceutical companies, tailoring our services to meet your specific needs. We are committed to your success; it is our mission to ensure you meet your product and company milestones.
Our experience includes a variety of product types including monoclonal antibodies, recombinant proteins, and next generation complex proteins. With success in clinical and commercial supply, our broad technology platforms, complete range of development services, and cutting-edge manufacturing processes enable your product to reach its full potential.
Preclinical to Early Clinical Manufacture
Our pre-clinical to clinical manufacturing services offer sales of 1000L to 2000:, and non-GMP pilot scales from 50L to 500L. We have five production sites that offer a global solution for your early clinical mammalian manufacturing needs. These state-of-the-art cGMP plants are located in: Slough (UK), Hayward, CA (USA), Tuas, Singapore and in our Biopark in Visp, Switzerland. The newest addition to our network is in Guangzhou, China is in the final stages of construction.
Late Clinical to Commercial Manufacture
Our late clinical to commercial manufacturing services offer scales of 1000L to 20000L. Our bioreactors include both single use technologies up to 2000L scale and stainless steel reactors from 6000L to 20000L providing you with the agility to react to changing product demand and readiness for the right commercial scale.
In determining which scale and location is most appropriate for your project, we discuss with you the clinical path, product needs and product launch/commercialization strategy. We consider both your mid and long-term needs.
We have five production sites that offer comprehensive clinical and commercial mammalian manufacturing. These state-of-the-art cGMP plants are located outside Boston in Portsmouth, NH (USA), in Porriño Spain, in Tuas, Singapore, in Slough (UK) and our Biopark in Visp Switzerland. This network offers a global solution to your late clinical and commercial manufacturing needs.
Our regulatory affairs teams have extensive experience with writing and supporting the preparation of Module 3 for your BLA/MAA in support of commercialization. We start 4-5 new BLA programs per year. Our proven BLA approach balances different priorities, timelines, risks and provides an overview of the entire program. It ensures the scope of work meets your needs, accelerating your product market readiness and reduces overall project time.
Our BLA approach is tailored to your needs
The Strategy (Defining the Goal)
Define the Approach (Study Methodology)
The Risk Assessment (Process Specifics)
Detailed Build of the Plan
Project Execution (Execute the Plan)
Product Lifecycle Management
We offer solutions for the entire lifecycle of your product from preclinical to commercial stages, from drug substance to drug product. Depending on the needs of your molecule and your program, we can leverage our global network and capabilities to offer the appropriate suite of services. The variety of our offerings provides the flexibility of a complete program - from gene to drug product, or the option to drop in at a later stage depending where you are in your journey.