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Translating Breakthrough Medicines From the Bench to the Clinic

From Bench to Bedside With BioCentriq's MS&T Team

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 cell therapy products that are either autologous or allogeneic 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.

Learn More About MS&T at BioCentriq

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.

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.

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.

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.

MS&T Creates a Bridge to Successful Manufacturing

Translates process development improvements for manufacturing.

Creates batch records and protocols to be executed in GMP.

Confirms and validates analytical methods to solidify QC strategy.

Scientist in lab operating centrifuge with blue gloves on hands

Ensures compliance with GMP protocols and procedures.

Translates process development improvements for manufacturing.

Creates batch records and protocols to be executed in GMP.

Confirms and validates analytical methods to solidify QC strategy.

Ensures compliance with GMP protocols and procedures.

CONTACT US

The BioCentriq Team

Combining years of specialized experience and technical expertise, the BioCentriq MS&T team thrives at the intersection of our clients and our process development and manufacturing teams.

They employ an open communication style to help identify issues before they arise, understand the diverse needs of each project, and ensure a smooth process from start to finish.

Get to know the team that will be pivotal in helping take your therapy to market.

SEE OUR TEAM

"I'm proud to say that what sets BioCentriq apart is our personnel. Our dedicated team is comprised of problem solvers dedicated to the unique needs of each project we work on."

Mary Loveras

Associate Director, MS&T

"As we become an extension of your team, we assume the same goal: bringing your therapy to market quickly and safely—and we do that by adopting a quality first approach and ensuring true GMP readiness from every angle."

Melissa Mastro

Senior Engineer, MS&T

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