Alkemy 101 Newsletter - November 2011

Is your Intellectual Property protected by your Vendor?

- What is in your Confidentiality Agreement or Service Agreement? - Are you getting a deal for the price you are paying or being taken advantage of? - What are the potential gaps in your IP development and protection strategy? Intellectual Property comes in all shapes and sizes, and sometimes companies don't know they even have any IP to protect other than a copyright. At an economic time when companies must adapt their position to best leverage their brand and grow sales, we are finding out quite often that the back door is left wide open. Case in point, a small company selected a particular Contract Manufacturing Organization (CMO) vendor that has an industry recognized seal of GMP compliance and a recognized brand name. After working with the CMO to get the ideal formulation and manufacturing the first several production batches, the company opted for a third-party investigative analysis of their finished product due to a small discrepancy. It was then that the company realized "things" were not what they seemed i.e. their formulation had been changed without their prior approval. Furthermore, because the CMO partner didn't charge the company for development on the final formulation, they would not support the investigation or disclose any details of the ingredients or testing of the product because it was "proprietary" ...to the CMO! In another case, a start-up company engaged in development of Botanical Drug products and related IP sought out a laboratory to contract the isolation and characterization of some new compounds. The contract lab they selected offered the company to do the work at a great rate including delivery of nearly twice the amount of the desired compounds. With compounds in hand, the company went on to the next stages of developing their product. They did not realize the lab they contracted also had their own business interest in the compounds. Because of opting to conduct the work at a lower price compared to some other bids received, they inadvertently waived the rights to the isolation and purification processes, the characterization IP and ultimately the exclusive use of the isolated compounds because these were outside of the Scope of Work. By the time the package was submitted, the various compounds were already on the open market. To help understand, identify and protect your IP, the folks at Ingredient Identity can help!

Alkemy 101 Newsletter - October 2011

Do you have a Quality Agreement with your Contract Manufacturer?

- What is a Quality Agreement, is it needed and how is it different than a Service Agreement? - How are the raw materials in your finished product qualified by your manufacturer routinely? - Should you get copies of test reports from your CMO partner for your finished products? A Quality Agreement is a legally binding document, which outlines specific quality parameters for a service to be rendered and identifies the responsible party (or parties) obligated to uphold those parameters under the Service Agreement. In lamens terms, its the upfront contract you put in place with your manufacturer in addition to the Service Agreement, to make a product in accordance with your standards and current regulations. A Quality Agreement defines all the aspects of a service or product relating to how identity, purity/potency, quality and overall safety of a given product is manufactured and maintained. Whereas the Service Agreement typically defines the legalese and scope of a project as well as deliverables for a set price, it does not usually address "HOW" the partner will accomplish the service; hence, the Quality Agreement. A well drafted Quality Agreement offers you protection should your contract manufacturer not uphold the terms therein. For example, if an agreed upon quality testing regimen is not followed or disregarded altogether, you may very well have legal leverage to change certain terms or dismiss the Service Agreement altogether. Same thing applies if your contract manufacturer is found operating not under cGMP compliance or changes raw material suppliers without your permission or appropriate qualifiction. Whether the CMO has an in-house laboratory or contracts with a third-party lab, you should request and have access to all testing records for your raw materials and your finished product on file.

Alkemy 101 Newsletter - September 2011

Why doesn't your HPLC Method Work Right?

- The Method wasn't properly developed or qualified - The "Reference Standard" wasn't really a standard at all - The analytical data was inaccurately interpreted - Wait! The method does work....the raw materials were switched without being properly qualified, etc. There are numerous reasons why an HPLC method might not work for your product, but are you getting the run around as to what the real reasons are, and more importantly what the right solution is? Moreover, how can you identify the right solution for the least amount of money? A strategic understanding of the appropriateness of method qualification should be considered fundamental to any Quality System. All too often, we are engaged in last minute troubleshooting for customers who had little or no early enough investment into the quality management of their products from an analytical perspective. Often, the mindset remains on finding a quick and dirty formulation followed by aggressive marketing of such products without qualifying the supply chain properly or ensuring analytical methods are in place. The resulting production delays, development fees and other costs relating to release testing, cGMP compliance and lastly mitigation of FTC or civil litigation can scale up to be insurmountable and cost-prohibitive in a very short period of time, if critical steps were not taken in the beginning. For more information on how to qualify an HPLC method or to determine if method development is required for your product, give us a call today!

Alkemy 101 Newsletter - August 2011

Identity Testing for Botanical Oils by HPTLC

- Affordable alternative to ID oil ingredients - Run multiple samples in parallel - 5 Day Turn-around Time for routine oils - Accurate chemical profiling of complex oil blends Yes, it's possible and more affordable than other more costly analytical techniques such as GC or GCMS! We've expanded our portfolio of Identity Testing methodologies for more essential and botanical oils used in Food Supplements, Cosmeceuticals and Aromatherapies. For comprehensive ID work of either pure oil ingredients or complex blends, we can profile the sample to confirm identity and compliance with cGMP's.

Alkemy 101 Newsletter - May 2011

Need FDA Inspection Support?

Alkemists Labs has expanded its consultancy services to rapidly tackle more of the challenges with meeting the cGMP's, such as Quality Systems audits, responding to FDA inspections including warning letters or on-site representation and testing complex dietary supplement finished products.

Some areas of support include the following:

• cGMP Compliance Audits of your manufacturing operations/parnters
• General SOP Writing and Guidance
• Scientific Data Review from internal/external contract labs
• Response Letters to FDA
• QC or QA Planning
• Investigative research including study designs
• Sampling and In-Process Testing
• Stability Study Designs & Protocols

Allergen Testing Now Available

Allergen testing for raw material ingredients by PCR Analysis for Allergen botanical ingredients is now available through Alkemists from AuthenTechnologies headed by Danica Reynaud, Ph.D. In an effort to support detection of known allergen contaminants/adulterants botanical raw materials by DNA presence, Alkemists is providing pass-through testing in collaboration with AuthenTechnologies to screen ingredients for customers.

Targeted allergens by PCR analysis from the following:
Almond, Brazil Nut, Hazelnut, Peanut, Pecan, Soy, Walnut and Wheat

Contact Bryan Fine at Alkemists for more information on the types of allergens and testing details.