WELCOME TO CHYMBIOTECH
CONSULTING

With over 40 years of postgraduate work experience in academia, government, and industry, covering all aspects of chemical product invention, development, manufacture and commercialization, from initial discovery, development of product specifications, process research and optimization, scale-up and commercial production and sales, complemented by a thorough understanding of the different regulatory environments (U.S. EP.A. TSCA, E.U. REACh, FDA, EMEA, cGMP, etc), and backed by a global network of expert colleagues, specialized labs and CROs/CMOs when needed, Dr McPhee  provides consulting services to companies small and large in the biotechnology and chemistry-related space.

Licenciado en Ciencias Químicas degree (equivalent to a North American B.Sc. Hons.) from the Universidad de Málaga (Málaga, Spain, 1978).

Ph.D. in Organic Chemistry from the University of Calgary (Calgary, Canada, 1986).

Post-doctoral Fellow at the Division of Chemistry of the National Research Council of Canada (Ottawa, Canada, 1986-88).

Prior to founding CHYMBIOTECH CONSULTING´s predecessor company DEREK McPHEE AND ASSOCIATES in 2003, Dr McPhee’s early post-secondary education career was entirely in industry, where he held a variety of positions of increasing responsibility at Uniroyal Chemical Co./Cie. and its various successor companies (Crompton & Knowles, CK Witco, Crompton Corporation and Chemtura, acquired in 2017 by Lanxess). Following this he served as Senior Research Chemist with Brantford Chemicals Inc. (now Apotex Pharmachem Inc.) and later as Director of Chemistry of AstaTech Inc. in the U.S., and V.P. of AstaTech Canada.

Sole inventor/co-inventor of over 150+ issued and pending U.S. and international patents.

Sole author/co-author of 25+ publications in peer-reviewed scientific journals, 2 book chapters, and 60+ papers presented at scientific conferences, published technical book reviews and other miscellaneous articles.

At the request of the granting agency a thorough evaluation of the progress reports and the new work proposal was conducted. Several flaws in the completed research and future plans were identified and solutions proposed.

Cost-benefit and strengths-weaknesses-opportunities-threats (SWOT) analyses of the whole project (absent in the original workplan) were completed to assess the feasibility of the various solutions and estimate the potential additional funding required under different scenarios.

Based on a review of the potential regulatory hurdles facing the target product (already a banned ingredient in certain consumer applications at the time) and the poor economics (the proposed raw material was not commercially available in the amounts needed to support eventual commercialization and was in fact more expensive than the target itself) it was recommended that the project be terminated without the additional funding.

This was anticipated to a be major obstacle for securing eventual regulatory approval as due to raw material variability, the company had been unable to develop a robust method to consistently minimize levels of this ingredient.

An evaluation of the extract composition and the chemistry of the constituent in question was carried out and several practical and cost-effective potential purification methods were identified.

As the company lacked the resources and know-how to verify each of the suggested options, an academic collaborator with expertise in the area was identified and approached on the company’s behalf to set up a quick evaluation of possible chemical routes to reduce the toxic component to trace or undetectable levels.

After appropriate confidentiality agreements between the company and the university were set up, timelines and costs were negotiated and the whole R&D project was administered on the client´s behalf.

A successful, economical and scalable method for removal of the toxic terpene was thus quickly identified, tested and then transferred to the client for future implementation. The desired regulatory approvals were obtained shortly thereafter.

The company and its technology were subsequently acquired by a major agrochemical firm specializing in biopesticides that is currently marketing the product.

Both the existing process and potential alternatives were evaluated and a water-based method proposed and tested by the company´s R&D staff.

Automation and accurate control of reagent addition were implemented by means of a pH feedback loop designed with the help of an OEM equipment manufacturer consulted for the project.

Problems with the existing product assays were concurrently discovered and resolved. Significant production cost savings were simultaneously realized through identification of alternative and cheaper suppliers of the key raw material.

After successful pilot and full-scale trial runs the process was transferred to one of the company’s overseas manufacturing facilities after an assessment of the respective capabilities of all its sites.

Solving this problem required either de novo development of a suitable scalable synthetic route for in-house or toll manufacture or identification of a potential existing supplier. Given the urgency in implementing the new manufacturing process, the latter was deemed the fastest and most economical approach.

After contacting all known suppliers of the reagent and confirming none had the necessary scale-up capabilities, the search was expanded to companies that based on their product portfolios might be using related reagents in their manufacturing processes.

This led to the identification of a major chemicals producer that was already making quite large amounts of a compound very similar to the immediate precursor of the catalyst for internal consumption. This firm was approached to confirm it had the know-how and production capacity to make the desired catalyst. 

A business case was prepared and presented to the potential supplier, highlighting the economy of scale benefits of expanding production of the common raw material and the possibility of creating a new revenue source with minimum investment and effort from making and selling the new catalyst. After reviewing this proposal, the company agreed become a raw material supplier for the original client and a supply agreement was negotiated and signed.

An evaluation of some 30 different commercial and shareware software packages based on technical features, ease of use, availability of training and technical support and cost was carried out.

A shortlist of software for further evaluation was compiled, demo copies were obtained from the respective suppliers, a panel of case studies based on actual in-house problems was assembled, and all the packages evaluated against this list, culminating with a purchase recommendation. After approval, the necessary R&D staff training was arranged and completed.  

As a complement to this project, an evaluation of commercially available automated chemical reactor systems suitable for process development was carried out.

Respective equipment suppliers were contacted and a database of features was compiled. Shortlisted companies were invited to the client’s premises to give presentations and extended on-site trials were arranged, again using real-life examples from the client’s R&D projects. At the end of this process, a purchase recommendation was made.