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.