The Rising Importance of Mexican Biotech

Q: How do Malvern’s activities solve predicaments for their clients?

A: The past decade has seen biopharmaceuticals become the fastest growing class of therapeutic agent with increasing numbers of novel molecules entering development every year. Underlying this is a fundamental shift in pharmaceutical industry investment and emphasis. The challenges of moving from the development of small molecule drugs to dealing with more complex biological materials are considerable and wide ranging. Malvern’s Bioscience Development Initiative (BDI) is an independent, agile and entrepreneurial organization. It partners with industry and academia to rapidly identify and assess analytical problems and bottlenecks within biopharmaceutical development and manufacture, and to prototype, develop and deliver solutions. Even though the company has presence in a wide range of industries and countries the market determines Malvern Instruments’ approach and specialization. Latin America has just begun to demand life science applications, in line with the US and Europe. In return, we expect far more specialization in LATAM over the next three years.

Q: How have the Malvern Bioscience Initiative’s (BDI) efforts supported its parent company?

A: Malvern’s Bioscience Development Initiative (BDI) is an independent, agile and entrepreneurial organization. It partners with industry and academia to rapidly identify and assess analytical problems and bottlenecks within biopharmaceutical development and manufacture, and to prototype, develop and deliver solutions. The initiative was established in 2012 to meet the evolving needs of a sector that is undergoing rapid change.

Q: How does Malvern Instruments contribute to the Mexican pharmaceutical industry?

A:The particle size distribution of active ingredients, excipients, granules and droplets is an important physical characteristic of the materials used to create pharmaceutical products that have the right Quality Target Product Profile. It can affect product performance, manufacturing scale up, processability and stability of the final drug formulation.

Key performance parameters such as dissolution, absorption rates and content uniformity can all be affected by the particle size distribution of various components of a drug product. For example, reducing particle size can speed up pre-formulation and formulation of New Chemical Entities (NCEs) with poor water solubility; thus getting a drug into pre-clinical or clinical trials quicker. Understanding morphological attributes of pharmaceutical products in conjunction with their chemical structure is also of great value.

The morphology of drug particles, granules, topical and Orally Inhaled Nasal Drug Products (OINDP) formulations provides information about bioavailability (BA) or bioequivalence (BE). Measurement of particle size and shape of the correct particle must be achieved and techniques such as Raman spectroscopy, in tandem with image analysis, can provide an accurate, objective and automated means to do this. Malvern Instruments has specialized technical personnel who are in regular dialogue with government agencies, such as COFEPRIS or the FDA in the US. This allows us to showcase new technologies and explain best practices for the use of specific technologies and advise on data interpretation.

Q: How important is the Mexican market for Malvern’s global strategy?

A: In a move that reflects continued sales growth in Mexico, Malvern Instruments has opened a new office in Mexico City. Operational since August 2013, the Mexico office provides both pre and after sales support to a growing customer base. It is also the venue for an increasing number of advanced training courses and seminars and is part of Malvern’s operational expansion in Mexico and throughout Latin America. The opening of the office in Mexico comes just a year after the establishment of a sales and applications laboratory in Sao Paulo, Brazil. Our investment continues with the launch of a Spanish website earlier this year. There is great demand for our products and services within Mexico and strong customer relationships and exceptional service are the cornerstone of Malvern’s business.