Matheus Engineering

Where Robustness meets Quality

Led by scientists with proven track record of solving complex engineering problems associated with batch, semi-batch and continuous processing.

Matheus Engineering

Where Robustness meets Quality

We Bridge the gap between lab and plant using our unique multidisciplinary approaches.

 

ICH Q8

Process robustness is the ability of a process to tolerate variability of materials and changes of the process and equipment without negative impact on quality

About Us
We have extensive experience in the field of process engineering activities associated with drug substance development and scale up in one of the leading pharmaceutical companies. We bring a unique multidisciplinary skillset of Chemical Engineering, Chemistry and Physical Organic Chemistry which is critical in identifying high risk areas in a regulatory synthetic sequence. Our strength lies in our ability to interface between chemists and engineers to assess risk level, develop de-risking strategies, and support scale-up.

36

+

Years of Experience

Services We Provide

Process Engineering Work Packages

We conduct experimental and modelling work packages to support process development, technology transfer and scale up assessment.

 

Project Management

We design and manage engineering work packages conducted at 3rd party companies to support chemistry scale-up, technology transfer and scale independence assessments.

Consultancy

We provide short or long-term project-based consultancy services for development and manufacturing organisations in our areas of expertise.

 

Our Expert Areas
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Understanding the kinetics of product and impurity formation along with the impacts of mass and heat transfer provide a critical foundation for the design and development of scale and equipment independent manufacturing processes. At Matheus Engineering we have found a multidisciplinary approach combining physical organic chemistry principles, traditional kinetic approaches (e.g. initial rate), modern kinetic methodologies (e.g. Reaction Progress Kinetic Analysis) and reaction engineering principles (e.g. thermodynamic characterisation of unit operations) to be the most effective solution.

How will your process perform across different scales and in different manufacturing equipment? In addition to helping you develop inherently robust manufacturing processes, Matheus Engineering have a strong track record of conducting scale and equipment independence assessment and mitigation activities for reaction, work-up and isolation unit operations to provide confidence when scaling into pilot and commercial facilities. In addition, we can also provide scale and equipment independence statements for registration dossiers.

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At Matheus Engineering we have expertise in the development of mathematical models and efficient generation of the data required to predict performance of unit operations across scales and facilities. This includes, but is not limited to, reaction/reactor models (from kinetic models to complex non-isothermal reactor models) as well as most of the common unit operations such as liquid-liquid extraction, distillation, filtration and drying.

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Hydrogenations are a popular reaction choice due to their atom efficiency but can be challenging to develop and scale due to complexities such as catalyst deactivation, product inhibition, mass transfer and gas supply rate constraints. At Matheus Engineering we bring a long track record of developing and scaling hydrogenation reactions to pilot and commercial scales. Our services include reaction design, development and understanding, manufacturing technology option assessment (Batch, Fixed Bed or Buss Loop reactor) and robustness assessment.

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At Matheus engineering we believe in selecting the right tool for the job. Not all processes are well suited to operation in batch or semi-batch mode - some may be better suited to continuous processing due to their kinetics, safety and process characteristics. We also believe the continuous processing doesn't suit all processes. At Matheus engineering we can help you select the best technology for your reaction.

In our experience the unit operations associated with downstream processing (work-up and isolation) do not receive the same degree of development focus as reactions, resulting in processing inefficiency and risk for these unit operations. Whether it's the distillation of a "not very stable" process stream or a slow, variable liquid-liquid phase separation, Matheus Engineering can guide you in development and de-risking scale up.

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At Matheus Engineering we have a strong track record of successfully developing and scaling robust crystallisation processes for regulatory step intermediates with a focus on optimising product purity, yield and overall cycle time. Our offerings include generation of solubility curves, metastable zone width measurement, crystallisation process design and robustness assessment.

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Filtration, washing and drying unit operation performance at pilot and commercial scales often vary significantly from laboratory experience due to many factors. At Matheus Engineering we can assess filtration rates, cake compressibility and the impact of drying parameters through scale relevant laboratory studies and modelling, and based on these advise you on optimal filtration, wash and drying protocols for pilot and commercial scales.

The Founders    

Dr Suju Mathew

Suju hold degrees in both Chemistry (MSc) and Chemical Engineering (BEng (Hons)). He did his PhD in the field of Kinetics and Reaction Engineering studying high pressure hydrogenation processes in multiphase batch and fixed bed reactors. His post-doctoral research under Prof. Donna Blackmond was in the field of Physical Organic Chemistry investigating complex organic transformations using modern kinetic methodologies like Reaction Progress Kinetic Analysis. He has 18 years of industrial experience working as a process engineering lead in Reaction Engineering group at Pfizer and in this role he has been involved in designing and executing engineering strategy for process development, scale-up, tech transfer, validation, and regulatory filing. He has proven track record of solving wide range of engineering issues associated with batch, semi-batch and continuous processes and successful implementation in Clinical and Commercial manufacturing facilities.

 http://www.linkedin.com/in/suju-mathew-8012ba12

Dr Jinu Mathew

Jinu did her MSc and PhD in Chemistry before joining as a postdoc in the field of Physical Organic Chemistry with Prof. Donna Blackmond looking at complex catalytic reactions using Reaction Progress Kinetic Analysis. She has 18 years of industrial experience at Pfizer and has held various roles during this time. She started off her industrial career as a process safety scientist in 2006 later moved to Reaction Engineering group in 2008. Since then, she has been involved in designing and executing engineering strategy for process development, scale-up, tech transfer, validation, and regulatory filing. She also has experience in working as a new product CMC strategist in preparing CMC submission documentation in alignment with guidance requirements across global markets and ensuring regulatory compliance.

 http://www.linkedin.com/in/jinu-mathew-53528a38

Careers

Address:

Matheus Engineering,
Discovery Park,
Sandwich, Kent,
UK, CT13 9FF

Mail Address:

contact@matheusengineering.com

Phone:

+447717001462

Contact

Get in touch