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Helen Baker: Drug Development & Delivery Article


Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product

Formulation development and manufacturing outsourcing compress timelines and mitigate risk, enticing many pharmaceutical and biotech companies worldwide to partner with outsourcing service providers in the early phases of the drug development process. This has resulted in an economic impact on the global formulation development out­sourcing market, which is expected to reach a value of $31.8 billion by 2027, up from $21.1 billion in 2021

“Clients need to ensure they part­ner with a CDMO that has a good awareness of both material supplier lead times, availability of alternate merchants, and who have the expert­ise to offer up viable alternatives that would not impact the performance of the end product,” says Helen Baker, Director, Pharmaceutical Sciences, Quotient Sciences. “A CDMO capable of both preempting and adapting to supply chain issues, while maintaining the integrity of a comprehensive and thorough development plan will be most attractive to pharmaceutical clients.”

The pandemic also forced the in­dustry to pivot toward new therapeu­tics, particularly mRNA-based drugs. As a result, many CDMOs have in­vested in new facilities and state-of-the-art equipment focused on biologics manufacturing.

This annual, exclusive Drug Devel­opment & Delivery report describes how drug sponsors and CDMOs are collaborating earlier, highlights how third-party contractors are navigating material shortages, and discusses how the industry is shifting to address dif­ferent therapeutic targets and mole­cules, such as mRNA.

Quotient Sciences: Clinical Testing & Development Under One Roof

A recent formulation development challenge that Quotient faced in­volved a BCS class IV candidate des­tined for solid oral delivery. The molecule exhibited poor solubility and permeability, with erratic absorption as an inevitable consequence. Al­though numerous solubility enhance­ment techniques exist, a critical factor in development was to ensure that the dosage form selected must be consis­tent and scalable to a sufficient size to support a commercial campaign. Hot melt extrusion offered not only a vehi­cle for manipulating the absorption properties by allowing for the incorpo­ration of enhancement aids but was easily controlled and scaled-up, with the additional benefit of optional con­tinuous manufacturing. A Design of Experiment approach was successfully used to select a polymer matrix that would provide the dissolution profile required by the customer. Despite some stability challenges that pre­sented themselves in early prototypes, a well-performing formulation was se­lected for Phase I studies, says Helen Baker, Director, Pharmaceutical Sci­ences, Quotient Sciences.

Quotient has its own Phase I clin­ical pharmacology units that are fully integrated with its drug substance and drug product facilities. “Offering both clinical testing and drug development capabilities under a single organiza­tion enables customers to experience a drastically reduced time investment for the development of products, rapid delivery and interpretation of clinical data, and subsequent reformulation that comes from each team being fully aligned,” says Ms. Baker.

Quotient Sciences also offers HPAPI handling capabilities in both its US and UK drug substance and drug product facilities in response to a ris­ing demand in the high-potency phar­maceutical ingredient (HPAPI) space. “Clients are increasingly seeking out CDMOs capable of rising to the chal­lenges that processing those com­pounds presents,” she says.

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