BioProcess Technology Consultants

Power of Process

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BioProcess Technology Consultants

Clone to Commercial

Talk to Us

BioProcess Technology Consultants

Design for Approval

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We’re world leaders in providing fully integrated strategic, technical, and regulatory solutions to address the challenges of biopharmaceutical product development. Our highly experienced consulting team delivers actionable insight directed to your needs and mission. That’s our Promise.

Our Services

  • Process and Analytical Development

    BioProcess Technology Consultants’ extensive process and analytical experience enable us to help you efficiently transition your products from clone to clinic to commercial while reducing technical and regulatory risks.

  • Outsourcing and Supply Chain Management

    BioProcess Technology Consultants offers comprehensive CMC outsourcing and supply chain management services to help you develop outsourcing strategies that meet your needs…

  • Manufacturing Strategy and Operations

    BioProcess Technology Consultants is devoted to helping you make sound operational decisions to support all your manufacturing, outsourcing, and facility requirements.

  • Quality, Regulatory and Compliance

    BioProcess Technology Consultants support all of your quality, regulatory, and compliance requirements through its advanceONETM division.

  • Program Management

    BioProcess Technology Consultants offers comprehensive and dynamic project planning and management services to keep your development and commercialization programs on time and within budget.

  • Product and Technology Assessment

    BioProcess Technology Consultants’ extensive experience and industry knowledge combined with our business acumen makes us your preferred partner to perform technology assessments…

Our Team

BioProcess Technology Consultants is the worldwide leader in providing expert biologics CMC consulting. We have helped clients advance many product candidates from research into clinical trials and have provided expertise and support for the commercialization of more than 15 currently licensed biologic products.

Thought Leadership

bioProcess Blog

Review the latest information, trends and developments in the bioprocessing industry including manufacturing, regulatory issues, biosimilars, vaccines, operational design, technology advancement and much more. BPTC experts provide new insight and analysis of upstream and downstream challenges and opportunities—be certain to bookmark us, and share with your colleagues.

Protein A: Extending this Platform Process Paradigm

by: Frank Riske, Ph.D. The use of affinity resins for recombinant protein purification has the potential to revolutionize downstream manufacturing processes. Such platform processes, based around affinity chromatography, will accomplish what Protein-A (PA) resin has done for monoclonal antibody therapeutics (MAb’s), a $85 billion market. For non-MAb recombinant proteins the use of affinity approaches will […]

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American Biomanufacturing Summit 2016

On May 10th, BPTC’s Senior Consultant, Patti Seymour, will be part of a panel discussion entitled: Examining Planning and Modeling Techniques to Achieve Effective Capacity Management in Your Biomanufacturing Network. The panel will focus on: Discussing strategic capacity issues when building a global network Planning for variability in market demand for both mature and a […]

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Biobetters Need a Definition!

By: Joe Siemiatkoski The Biosimilars Clinical Studies & Analytical Similarity Summit held in Boston from March 21-23, 2016 covered a broad range of topics ranging from assay considerations to clinical study design and regulatory filing strategies. One topic that came up in virtually every presentation or discussion forum was the concept of “biobetters”. There is […]

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