Getting the First Batch Right

Companies making the transition from pre-clinical to clinical trials often run into serious problems.

“If companies don’t validate their utilities, equipment and production processes in a way that meets GMP (Good Manufacturing Practice) requirements and standards, they can lose months of valuable time and money,” says Eran Yona, CEO of Bio-Chem Engineering, explaining that the companies later may have to stop and do the validation procedure again.

Bio-Chem helps small and middle-size companies prevent these and other problems, by developing and troubleshooting production processes, establishing Quality Assurance systems and supporting validation activities.

“We enable them to see the ‘big picture’ so that they get their first (clinical) batch right,” says Yona. He notes that Bio-Chem has successfully helped more than 50 companies reach clinical production, establish large-scale production and qualify facilities for marketing products after receiving FDA/CE approval.

To do so, Bio-Chem assists with Chemistry Manufacturing and Controls (CMC), GMP and Engineering documentation, the selection of preferable technology, Quality Assurance, GMP, external audits, as well as the planning of clean rooms, including the architecture and conceptual design.

Yona points out that Bio-Chem continues to offer services throughout the scale-up and quality improvement stages. “We assist in establishing and improving quality assurance systems, quality control, cleaning and validating new areas , technical services, on-going maintenance and the improvement of production technology and GMP requirements implementation and training.”

Bio-Chem has worked with a wide range of Israeli and multinational biopharma and medtech companies. Among them: Kamada, BTG, Omrix, Teva, Taro, Sigma Aldrich, BrainStorm, Navotech, Valtech, Neopharm, Chiasma, Prolor, Clalit, Eticon, AB Dental, Sealantis, BioLine RX, Colbar and HyLabs.

Prior to founding Bio-Chem six years ago, Yona had extensive industry experience as a process and validation engineer at Teva and in various research and production capacities at Migal, QBI, CTS and Rafa Laboratories.

Bio-Chem’s staff includes five engineers as well as technical and administrative support staff.

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