Manufacturing, Science, And Technologies (MS&T): Translating Breakthrough Medicines From The Bench To The Clinic

Source: BioCentriq

BioCentriq's MS&T team serves as a hands-on liaison between our partners and our own process development and manufacturing teams, working to consistently improve how therapies are advanced from bench to bedside.

Our MS&T team is equipped with the technical know-how and regulatory insights to ensure the successful translation of novel processes into the manufacturing suite. We perform quality assessments as early as possible in the product lifecycle and employ Quality-by-Design principles to determine key attributes and parameters critical to the production of high-quality drug products.

Working closely with our partners, we first help identify the Quality Target Product Profile and Critical Quality Attributes (CQA) for the therapeutic. The MS&T team seeks to define the Critical Process Parameters and Critical Material Attributes and key inputs to the process, all based on the CQAs initially identified.

Our team works closely with biotech companies who have early-stage products that are either autologous or allogeneic, cell therapy or gene therapy, and rely on a variety of cell lines. Our expertise spans multiple modalities, and our standard approach is designed to ensure successful tech transfer of products in any clinical phase.

The BioCentriq Approach to MS&T

  • Deploy a tailored, phase-appropriate approach for technology transfer.
  • Minimize scale up risks with a Quality by Design approach.
  • De-risk innovative therapies by using detailed gap assessments.

Our MS&T team combines diverse expertise that's used to bring your product from bench to scale. Learn more about how we optimize tech transfers and utilize a Quality by Design framework to get your product to clinic.

Technology Transfers

We have a reliable and adaptable approach to technology transfer that leverages our state-of-the-art facilities and experienced staff to enable successful implementation of at-scale manufacturing. Our highly integrated team of scientists, engineers, and operations personnel work together to ensure that key translational activities (e.g., initial knowledge transfer, tech transfer from process development to manufacturing, etc.) are completed using our robust and systematic procedures.

Quality by Design Framework

To accomplish the fastest time to market with the highest quality product, our MS&T team performs quality assessments as early as possible in the product lifecycle. We employ our streamlined Quality by Design framework to help our partners identify quality target product profiles and CQAs early and extrapolate the Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) necessary to establish an effective production process for clinical delivery.

The Impact of BioCentriq's Hybrid Model on MS&T

Our hybrid, people-in-plant model enables truly collaborative partnerships where our partners can take part in the evolution of their biotherapies. Through this transparent paradigm, partners can work alongside our MS&T team to offer insight into their novel drug product and gain exposure to how we transform the production process from development stage into GMP manufacturing.

Single Use Technologies

Our emphasis on single-use technologies allows our MS&T team to achieve higher flexibility, efficiency, and product quality in the scale-up and manufacturing process. This also significantly reduces the time to clinic by eliminating the need to perform cleaning and sterilization validation studies.

Scale Up and Scale Out

Our MS&T team looks at implementing manufacturing methods that can be adequately scaled up or out based on the stage of development and the intended product delivery strategy. We have experience delivering patient specific and off-the-shelf therapies.

Process Validation

Using a Quality by Design approach, BioCentriq prepares each product for process validation starting at pre-IND. It is important to build the foundation early with a defined Quality Target Product Profile and critical quality attributes. Those attributes and subsequent critical process parameters will be refined through the clinical results ahead of method validation and process performance qualification.

Documentation & Training

Our MS&T engineers will steward each product through its clinical and commercial lifecycle. This includes providing hands-on training to key manufacturing and quality control personnel and drafting the batch documentation that will guide the production of every dose of product.