Innovations in Pharmaceutical Manufacturing on the Horizon Technical Challenges, Regulatory Issues, and Recommendations (2021) / Chapter Skim
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3 Innovations in Manufacturing Drug Products
3 Innovations in Manufacturing Drug Products
Pages 23-35
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From page 23... ...
The first describes innovations in the manu- there have been numerous explorations of the use of virfacture of conventional drug products, the second high- tually all those forms for pharmaceutical-dose production lights innovations in drug-product forms, and the third at the research and development stage, only a few are suffocuses on novel excipients that enable new drug-product ficiently advanced to be commercially viable within 5–10 formulations. In addition to highlighting the emerging years (Jamroz et al.
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From page 24... ...
With simple adjustment of the number of powder layers, the number of drops, or Regulatory Challenges the amount of filament deposited, AM forms lend themselves to tailoring the dosage to the patient. AM also read- A common regulatory challenge arises in the approvily accommodates alternative 3-D shapes and thus tablet al process for the technology: an integrated AM system designs.
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From page 25... ...
portance for product quality are nondestructive measurements of residual moisture content that use spectroscopic Technical Challenges methods that can be implemented on multiple scales. Important operational strategy modifications are approaches The technical challenges of improving batch operato controlled (primary)
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From page 26... ...
From a drug-loading perspective, microparticles can shield an API from environmental conditions (such Regulatory Challenges as temperature, pH, oxidation, and proteolytic degrada tion) and can protect the body from harmful side effects The main regulatory challenges are associated with of the API (such as irritation, mucosal damage, and cell the extensive effort required for the initial and continu
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From page 27... ...
The new formulations are intended novel excipients. The most commonly used excipients in to overcome problems related to drug solubility or pharmicroparticle delivery systems are biopolymers of plant, macokinetics and pharmacodynamics profiles, improve animal, or microbial origin (Lengyel et al.
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From page 28... ...
extracellular space. Perhaps most relevant to drug develBecause these drug products are still relatively new and opment is the fact that exosomes can serve as vehicles their manufacturing processes are emerging, a Quality by to transfer membrane and cytosolic proteins, lipids, and Design approach to gathering deep product and process RNA between cells and thus provide an important mode understanding is needed.
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From page 29... ...
Manufacturers have become adept at Regulatory Challenges side-stepping the introduction of new excipients by cre atively using combinations of listed excipients to address Major regulatory challenges include guaranteeing formulation challenges posed by new molecular entities. drug safety, efficacy, and stability during scale-up; in- For example, the number of excipients used in approved creasing familiarity with new unit operations; and ensur- monoclonal antibody (mAb)
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From page 30... ...
Reasons for the use of a new excipi- gate is a serious delivery concern, given the lethality of ent include newly understood limitations of members of the "warhead" component of the ADC. There is a strong a given class of IID-listed excipients, the increased com- driver for moving beyond the repertoire of excipients plexity of new drugs and dosage forms, and the needs of currently used to stabilize mAb therapeutics to new exnew types of manufacturing unit operations (IPQ 2020)
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From page 31... ...
The main regulatory challenge associated with the Technical Challenges introduction of new excipients is that they are approved with the new molecular entity; there is no mechanism for Regardless of the driver for the introduction of approval of new excipients in isolation. Manufacturers novel excipients by a manufacturer, the result is a new must assume the combined time, costs, and risks associstream composition that persists through the formula- ated with demonstration of the safety of a new excipient tion and filling operations.
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From page 32... ...
and trade organizations -- such as the joint Novel Excipients Working Group of the International Consortium for OVERCOMING REGULATORY CHALLENGES Innovation and Quality in Pharmaceutical Development and the International Pharmaceutical Excipients Coun- As new technologies for manufacturing drug prodcil -- are working with FDA to address the new excipient ucts advance in the pharmaceutical industry, early and regulatory barrier (IPQ 2020)
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From page 33... ...
2019. Development and Validation of Extrusion concomitant development of a USP and National Formu Deposition Additive Manufacturing Process Simulalary monograph for novel excipients might spur excipient tions.
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Pathway for Introducing Novel Excipients. https://www.
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From page 35... ...
2019. Novel Excipients – Update on Recent 2020)
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