GMP Cell Manufacturing and Process Development

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Process Development and CDMO Services for Cell & Gene Therapy Manufacturing

Our commitment as your partner extends beyond developing an optimal process for manufacturing your therapy. From the outset we work with you to build in the necessary flexibility for meeting the demands of scaling to commercialization. If you are ready for the next steps, set up a free consultation today. Our mission is to deliver innovative solutions that enable cell and gene therapies to reach more patients.

While patient safety is our paramount concern, we are keenly focused on helping you bring down the cost and speed up your manufacturing process. With our simplified and lean services, we can provide you with a quicker pathway into the clinic than other CDMOs, without sacrificing quality. We offer in-house process development for gene modified therapies, GMP patient sample processing for Phase I and Phase II clinical trials, and GMP manufacturing of iPSC cell lines.

Inquire About PD and CDMO Services

Process Development

Let us scale up your manufacturing process and optimize it for the clean room. During PD, we will find out what it takes to turn your program into a reliable process that’s robust enough for clinical manufacturing at scale.

  • Raw materials selection and supply agreements
  • The optimum combination of in-house testing and testing in your hands
  • Scheduling time in our GMP manufacturing suites
  • Regular process evaluation and troubleshooting to improve inefficient steps

GMP Manufacturing

When your process is ready for manufacturing, we’ll move into our in-house clean room suites for engineering runs and clinical production of your cell or gene therapy.

  • ISO Class 7 certified facilities (Class 10,000) with associated development and quality control labs
  • Dedicated Quality team for regulatory support and oversight of facility maintenance, automated batch records, personnel training, and raw materials inspection, testing, and tracing

Why Should You Partner With Us?

Our in-house team features world class experts to provide you with cutting edge technical understanding. We connect scientist to scientist at all stages of your project – to understand your needs, offer practical recommendations, and faciliate ongoing conversations about the nuts and bolts of the project. We’re adaptable and flexible, and we can advise you on materials selection according to your needs. We pride ourselves on exceptional customer service.

Are you a Principal Investigator looking for Phase I clinical trial support for cell engineering? Inquire about our program with TcBuster for investigator-initiated Phase I clinical trials. Learn about the TcBustergene transfer system.

  • Transfer your gene(s) of interest into TcBuster and optimize for use and transfection parameters (10-12 weeks)
  • Provide you with clinical grade engineered cells – 4.5 months from date of order (enough to treat up to 15 patients)
  • 3 GMP performance qualification runs in clean rooms to meet release criteria and CMC support (optional)

Steps in Partnering With Us

We start with your end goal in mind and design each step accordingly. Our team consults with you to walk through the project step by step. During these conversations, we will develop a detailed Statement of Work (SOW) to define

  • Project scope and experimental design
  • Timelines, milestones, deliverables, project team, and costs
  • Custom requirements for deliverables
  • GMP manufacturing space availability and scheduling

Following agreement on the SOW, we will deliver a timely quote and be ready to initiate work on the project. At this time we receive your materials and all additional relevant information.

What to Expect Throughout the Project

  • Accessibility of project manager or technical lead to facilitate discussions
  • Delivery of technical progress reports as defined in the SOW – from project manager or technical lead
  • Shipment of cell samples and other materials for your testing

What Defines Project Completion?

  • Shipment of engineered cells in agreed-upon formulation, #cells/vial, packaging, and labeling
  • Delivery of characterization reports, documentation, and other deliverables as defined in the SOW
  • Quarantine of extra materials
  • Project offboarding and archiving

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image of Scott Silaika, Director Commercial Business Development, Cell and Gene Therapy

Scott Silaika

Director, Commercial Business Development, Cell and Gene Therapy

Scott Silaika has over 20 years of business development experience in drug development and manufacturing services, spanning from discovery through commercial, within the contract development and manufacturing (CDMO) industry. Scott’s experience includes numerous examples of identifying, leading, and supporting customer projects on high profile, mission-critical initiatives.

Prior to joining Bio-Techne, Mr. Silaika held commercial development positions at AbbVie, Aesica, Albany Molecular, Avara, and Ricerca Biosciences. He earned his undergraduate degree in Chemical Engineering from Rensselaer Polytechnic Institute and his MBA from the State University at Albany.