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| home > pmps > winter 2003 > quality and risk management in botanical supply chains |
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 PUBLICATIONS |
Pharmaceutical Manufacturing and Packing Sourcer
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Every company that uses plant-based ingredients in their products faces a number of sourcing challenges. Whether the product is a pharmaceutical grade drug or API; a personal care or 'cosmeceutical' product; a plant-derived medicinal extract a traditional herbal medicine or a functional food from a raw material sourcing perspective, the issues of quality, sustainability and traceability are remarkably similar. Techniques and processes devised to tackle these issues in relation to traditional medicines are very relevant even to manufacturers of pure plant-based compounds and derivatives. Many leading companies now recognise the importance of demonstrating efficacy to customers through the performance and documentation of clinical trials. Mounting scientific evidence can only serve the marketplace in a positive way. However, the validity of this data will be severely challenged if the basic plant raw materials are of an inadequate and variable standard, as this will affect the final product. The issues of quality, batch-to-batch variability and sustainability should be tackled in order to maintain consumer confidence.
Trends in Botanical Materials Usage and Regulation
Over the past 10 to 20 years, plant-derived products have enjoyed differing fortunes according to the market sector. Despite the unrivalled chemical diversity of the plant kingdom and past successes in drug development from morphine to Taxol, pharmaceutical companies have been drawn away from natural products by the allure of combinatorial chemistry and high-throughput screening. The reasons for this are complex but include a belief in greater returns per unit of expenditure, better control over intellectual property (IP), and a realisation of the inherent difficulties in managing a plant-based supply chain.
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By Dr Trevor Theobald, Business Development Director, Indira Walker, Quality and Regulatory Affairs Director, and Dr Christopher Stewart, Botanical Sourcing Manager, at Kings
Dr Trevor Theobald is Business Development Director at Kings. He has many years' experience in both R&D and business development roles in the natural products and extracts arena with Courtaulds and British Sugar before joining Kings.
Indira Walker is Quality and Regulatory Affairs Director at Kings. She was UK/Eire Quality Manager/Qualified Person for Pharmacia Ltd and has QA and Regulatory experience at Daiichi Pharmaceuticals, Eli Lilly and Fisons plc.
Dr Christopher Stewart is Botanical Sourcing Manager at Kings. Previously with Oxford Natural Products, he has experience in managing crop development projects in the UK, Vietnam, the Caribbean and the Philippines.
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Indira Walker |
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Dr Christopher Stewart |
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
More info >> |
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