Lehrman Biopharma: Mission
To serve the needs of biotechnology and pharmaceutical
companies that are bringing important new therapeutics and
pharmaceutical technologies to market. Lehrman Biopharma
supports late stage research that improves candidate
developability and supports CMC activities at all stages of clinical
development.
Quality by design (QbD), cGMPs, GLPs, risk management and otherpractices are used as appropriate. Additional experts in
pharmacokinetics, clinical development, and medicinal chemistry
are assembled into ad hoc teams to accomplish the goals listed
above when necessary to achieve the goals listed above.
companies that are bringing important new therapeutics and
pharmaceutical technologies to market. Lehrman Biopharma
supports late stage research that improves candidate
developability and supports CMC activities at all stages of clinical
development.
 | Utilizing internal client resources or CROs, perform | |
| preformulation studies to optimize physical and chemical properties of proposed candidates, ensuring successful development, | ||
| Develop formulations to be used in preclinical and clinical | |
| trials, | ||
| Manage manufacture of drug substance and drug product via | |
| CMO organizations, | ||
| Develop analytical methods for in-process and final product | |
| testing with the help of CRO organizations, | ||
| Identify and resolve chemical issues that interfere with | |
| product development. | ||
| Serve as an expert witness | |
| Support non-technical companies as a subject matter expert. |
Quality by design (QbD), cGMPs, GLPs, risk management and other
pharmacokinetics, clinical development, and medicinal chemistry
are assembled into ad hoc teams to accomplish the goals listed
above when necessary to achieve the goals listed above.
Lehrman Biopharma
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