EXPERIENCE in the analytics of a wide array of biologically-derived therapeutic and vaccine products from natural and recombinant systems; simple, complex, and conjugated modalities; originator and biosimilar products; purified well-characterized protein and nucleic acid materials; advanced medicinal therapeutic products (ATMPS) such as gene therapies and cellular therapies. EXPERTISE in classic and current analytical technologies for physiochemical analysis and in vitro potency assays in R&D and phase-appropriate GMP laboratory environments. ENGAGED in professional scientific organizations; participating in international conferences, forums and symposia; authoring and editing leading biopharmaceutical publications.

When Efficiency Matters Most

WHETHER YOUR PRODUCT IS BREAKTHROUGH, PRIME, SAKIGAKE, OR FAST TRACK; BIOSIMILAR OR ORIGINATOR; NOVEL OR LEGACY; or there are just AGGRESSIVE SENIOR MANAGEMENT GOALS - EVERYONE HAS AN ACCELERATED CMC TIMELINE THESE DAYS.

When time is money (and when is it NOT?), you truly cannot afford to make strategic CMC mistakes. There are many unexpected surprises in the development and production of biotech products—don't let an outdated or inadequate CMC strategy be one of them. Since 1998, we have worked with over 120 biotechnology, biosimilar and gene/cell therapy products from more than 50 world-wide sponsors, from small virtual groups to global pharmaceutical firms, from pre-clinical to commercial approval (and everything in between). With over 30 years of real-world direct experience in the field of biological product analytics, Global Biotech Experts LLC can help you design the most efficient CMC analytical and stability strategies at any phase of development, in any global region.

Principles to Practice - Operations and Compliance

R&D, GLP, GMP - are you (or your contract organization) using the appropriate quality system to minimize the risk to your critical materials and data? Let us help you verify the applicable requirements and confirm that they are being followed at the bench.

Inspection coming? Don't let the inspector be the first one to point out method problems or laboratory compliance gaps. We have decades of personal experience in both receiving and conducting pre-approval inspections (PAI) and routine GLP and GMP inspections.

Known problems? We have participated in dozens of analytical troubleshooting and compliance observation remediation plans to help firms achieve successful outcomes.

We have seen hundreds of good operational examples, and thousands of good examples of bad operational examples!

"Smooth Seas Do Not Make Skillful Sailors"

Over the years, we have helped guide many clients through the roughest project "hurricanes" and operational "tornadoes" of both large and small firms.

By continuous participation in numerous scientific conferences, forums and publications, we are very engaged in the field of biopharmaceutical product CMC issues. Our extensive pro bono scientific activities assure that we remain current on industry best practices and regulatory expectations.

From these activities as well as from client projects that span the industry around the world, we can rapidly detect emerging trends. With a wide range of hands-on experiences, we have real-world knowledge of what works (and what doesn't).

All of these features combine to provide highly effective input to our consulting and training services. Utilize our skills to help navigate your course, too!