Pharmaceutical Outsourcing Q3 2023 - 30

CONTRACT MANUFACTURING
programs designed to evaluate a specific technology and identify
whether it would be suitable for a given API. Following successful
screening, clients can then decide whether to invest in the equipment
needed to carry out this technique in-house or to proceed with using
the CDMO's facilities. Even with the capabilities to perform a feasibility
study in-house, there may be additional challenges in taking the API
from R&D to a larger scale while complying with GMP protocols. As an
alternative, CDMOs can offer large scale up based on their feasibility
studies - enabling the manufacture of GLP test articles and GMP
clinical trial materials, which can save months of work and reduce
financial costs. Outsourcing also affords flexibility during periods of
reduced activity on a project. For example, during lengthy toxicology
studies, engagement with a CDMO can be paused - whereas in-house
costs would remain fixed, despite the lower demand on resources.
Choosing a CDMO with wide-ranging technical capabilities opens
further possibilities for developing drugs with poorly soluble APIs.
With a better stocked toolbox at their disposal as well as the relevant
expertise, such CDMOs have the scope to successfully combine
solubilizing techniques and alternative dosage forms for an optimal
outcome. For example, nanosuspensions could be paired with
techniques such as spray drying or incorporated into a drug-eluting
device or dissolvable film strips.
expertise are prohibitive to this holistic approach in-house.
Key Takeaways
There are many effective methods to enhance solubility, which can in
theory allow a growing number of poorly soluble APIs to reach their
full therapeutic potential. But without the relevant expertise and
resources, projects can easily stall, fail, or see costs spiral.
Outsourcing to an expert CDMO can help reduce the impact
on timescales and budget compared to performing solubility
enhancement in-house, as well as providing peace of mind to
developers that operations
are compliant with GXP standards.
However, it's of paramount importance to select the right partner
to work with. One solubilization technique will not fit all poorly
soluble APIs, so a CDMO with a broad range of technical expertise
and facilities will allow more shots at goal, increasing the chance of
delivering the target product profile.
References
1. Savjani KT, Gajjar AK, Savjani JK. Drug Solubility: Importance and Enhancement
Techniques, ISRN Pharm 2012; 2012:195727
2. Key Considerations for Ocular Drug Development & Solubility Enhancement Techniques.
Available at https://lubrizolcdmo.com/resource-center/guides/premium-thank-yousolving-solubility-challenges-for-a-novel-oncology-drug/.
Accessed July 7, 2023
3. Reich J, Weyer FA, Tamura H, Nagaoka I, Motschmann H. Low Endotoxin Recovery-
Masking of Naturally Occurring Endotoxin, Int. J. Mol. Sci. 2019, 20(4), 838
4. Schittny A, Huwyler J, Puchkov M. Mechanisms of Increased Bioavailability through
Amorphous Solid Dispersions: a Review, Drug Deliv. 2020, 27(7), 110-127
In most cases, cost and lack of
Dr. Robert W. Lee is President at Lubrizol Life Science Health - CDMO
Division. He holds BSs in Biology and Chemistry from the University
of Washington and a PhD in Physical Bioorganic Chemistry from
the University of California, Santa Barbara. Rob has published
more than three dozen articles and five book chapters plus holds
11 issued patents and 15 provisional or PCT patent applications. He has over 30
years' experience in pharmaceutical research and development.
Pharmaceutical Outsourcing | 30 | July/August/September 2023

https://lubrizolcdmo.com/resource-center/guides/premium-thank-you-solving-solubility-challenges-for-a-novel-oncology-drug/.

Pharmaceutical Outsourcing Q3 2023

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