Contract manufacturing organizations' work may involve performing the work in-house or using a trusted CRO to outsource testing to. Other options to consider are qualifying a vendor to handle overflow work for you or looking at insourcing options.
Clean rooms, including manufacturing suites, must be kept in a state of microbiological control. This is accomplished by introducing and maintaining a sound cleaning and sanitization program within these controlled environments to prevent the microbial contamination of the products being manipulated. Routine environmental monitoring of the manufacturing suites allows you to continue to monitor the state of control of your facility.
Products & Services
From early preclinical formulation development through clinical and commercial product release, we provide timely, tailored science, and trusted products and services to support the development of your biologic.
Antibody/Protein Manufacturing
Our team of scientists can ensure the quality, consistency, and integrity of a client's cell and viral banks, promoting a smooth and successful outcome for their manufacturing campaigns.
Our manufacturing/production capabilities include:
- Mammalian and microbial cell banking
- PhI/II vaccines and viral challenge stocks
- Monoclonal and polyclonal antisera production
Cell and Gene CDMO Solutions
With the benefit of a shared quality system, faster internal technical transfer, and process crossover between teams helping to reduce program bottlenecks and providing a seamless experience, we are uniquely positioned to help our cell and gene therapy clients accelerate and achieve critical development goals from discovery to commercialization. We have supported the development of 10 FDA-approved cell and gene therapies and have conducted more than 900 studies in this field over the past year. Our aim is to enhance client access to this wealth of scientific and regulatory experience as well as harnesses the power of our multidisciplinary bench of experts to problem solve in a collaborative manner every step of the way.
Explore our cell and gene therapy CDMO solutions:
The approval process for ensuring the identity, potency, purity, safety, and effectiveness of a biologic is complex, and its effective navigation is critical to the ultimate commercial success of a product. With more than 50 years of experience, our Biologics Testing Solutions group has the proven knowledge, expertise, and capacity to address challenging projects for biotechnology and pharmaceutical companies worldwide. Our primary emphasis is on quality, which is enforced through continuous training and internal audit programs, ensuring that our practices are in compliance with global regulatory guidelines.
We support clients throughout the drug development continuum, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Our facilities in the US, UK, Ireland, France, and Germany are part of a global scientific network, allowing us to offer clients greater flexibility, experience, and expertise to maximize resources and optimize results based on specific program needs.
Our comprehensive biologics testing services include:
As you strive to improve efficiencies and reduce costs, it is wise to evaluate strategic sourcing initiatives, including closer collaboration with contractors. The RightSource℠ program is a scientific staffing program that provides flexible insourcing/outsourcing options for biologics developers and manufacturers. We work with you to evaluate your QC testing programs and select the best-suited, most affordable mix of insourcing and outsourcing options.