A guest column article on Preformulation of Excipients in Biologics Development was published in Bioprocess Online
Bioprocess Online, Guest Column, September 28, 2023
Plano, Texas — Preformulation of Excipients in Biologics Development by Andrei Blasko, Clearview Pharma Solutions LLC was published in
Also, ISPE scooped up the article for its SmartBrief newsletter on September 29, 2023.
Most ingredients in drug products are excipients, and impurities in excipients are common roots of drug product instability. Novel excipients are considered active pharmaceutical ingredients for toxicity testing, impurity profiling and physicochemical characterization, but different regulatory bodies have different definitions of "novel excipient," and new regulatory guidance on genotoxic and elemental impurities as well as excipient performance and degradation testing should not be ignored, writes Andrei Blasko, president and CEO of consulting firm Clearview Pharma Solutions.
Clearview Pharma Solutions, LLC announces its relocation to Texas
Texas Secretary of State, March 2023
Plano, Texas — California Certificate of Conversion was filed with the California Secretary of State effective as of February 28, 2023
Certificate of Conversion, Plan of Conversion, and Certificate of Formation was filed with the Texas Secretary of State effective as of March 15, 2023.
Clearview Pharma Solutions, LLC announces two types of consulting services for drug development
San Bruno, California — Clearview Pharma Solutions LLC (www.clearviewpharmallc.com), a pharma/biotech consulting company for drug development announces that is offering two types of retainer services: “Pay for Work” and “Access” Retainer.
The pharmaceutical industry is a fast-paced environment. When a challenge arises that demands a deeper level of expertise than what you currently have on staff, you want to have access to an expert right away. This allows you to keep your overhead low while being able to handle uniquely complex situations as you meet them head-on.
We offer consulting on full cycle of drug development:
Analytical development and validation
Strategic long-term plan for formulation development
Due diligence and Innovation
What differentiates us from the competitor is the strong physical organic/bio-organic expertise of Founder, Dr. Andrei Blasko (evidenced by 90+ publications and patents). A high level of expertise is key to a successful drug development process. Many instabilities and/or delivery problems can be attributed to the physicochemical properties of the active ingredient and excipients and most of the time, to the impurities in excipients.
The choice of consulting retainer depends whether the client has an ongoing project with defined deliverables (“Pay for Work” Retainer) or needs to solve unforeseen problems on an ongoing basis (“Access” Retainer). Learn more about the two types of consulting retainers that Clearview Pharma Solutions LLC offers at www.clearviewpharmallc.com.
“By having somebody like myself on retainer, you have the peace of mind that any time something comes up you can count on me. My responses will be timely to keep your project on track. You can rest assured knowing that I am your adviser, that I am on your side, and that I will consistently support your business and help you with any of the challenges that might come up.” - Andrei Blasko, PhD, FRSC, Founder of Clearview Pharma Solutions.
“The value I deliver is far greater than the investment you are making to pay for my retainer. The monthly fee for Access retainer could prove to deliver a 5x return with significant development time reduction. If this is something that interests you, I welcome a phone conversation at your convenience.”
Andrei Blasko, PhD, FRSC
Clearview Pharma Solutions LLC