However, these innovative new therapies require close collaboration and creativity throughout the formulation development process from development and contract manufacturing organizations (CDMOs). “Improving productivity in pharmaceutical development is important, but it should not come at the expense of creativity,” says Dr. Detlev Haack, Head of Research and Development at HERMES PHARMA. “To develop truly innovative products, R&D relies on pharmaceutical developers who think outside the box. Only with creative people willing to take responsibility for new ideas will we be able to meet the changing needs of patients and consumers in the 21st century. John Rigg, chief executive officer and vice president of Exelead, says the development and application of lipid nanoparticles (LNPs) is gaining momentum. As a drug delivery system, LNPs are more easily used to deliver drugs whose payload may be a protein, small molecule, large molecule, oligonucleotide (DNA/RNA) or a combination of the above. “Exciting developments are emerging around lipid conjugation and the integration of different forms of oligonucleotides into LNPs,” says Rigg. “These components offer the potential to treat and cure what was previously incurable and incurable. Patient-specific (personalized) drugs are rapidly changing the landscape of development pipelines in the industry.

Quotient Sciences` business model integrates CDMO and CRO activities into a single organization. This approach simplifies supply chain outsourcing, speeds up schedules and makes drug development more cost-effective, says Dr. Peter Scholes, Chief Operating Officer, Quotient Sciences. As CDMO, Exelead focuses on complex liposomal and PEGylated formulations and develops and produces batch formulations for the treatment of rare diseases and small patient populations. Exelead has recently expanded its formulation and analytical development capabilities to help its clients develop drugs for unique subgroups of the population. This brings new challenges that require manufacturing flexibility, strong business-to-business communication and supply chain management. “For example, personalized medicine doesn`t leave much time between oligonucleotide sequencing (or just before sequencing) and when the product needs to be formulated in an LNP on our site,” says Rigg. “These real-time forecasts, which only take weeks to manufacture and publish the next clinical batch, present challenges that we have been able to overcome with the refinement of our existing systems and the implementation of the new system.” CPL focuses on non-sterile liquid pharmaceuticals and semi-solid topical pharmaceuticals. With these dosage forms, CPL sees a trend towards smaller commercial batches with an increasing number of formulations for rare indications.

In addition, companies incorporate poorly water-soluble APIs into formulations that require a high solvent content. This presents the challenge of ensuring sufficient solubility while ensuring good sensory properties for high patient acceptance. Metrics Contract Services specializes in the following formulation areas: GMP analysis and formulation services for the pharmaceutical, biotechnology and healthcare industries As an outsourcing formulation development organization, Aztech implements risk management concepts and quality approaches by design in its protocols to provide a more focused and efficient pathway in formulation development. This, according to Dr. Higuera, translates into better and more robust formulation platforms, increases productivity and creates a model for future project opportunities. Metrics scientists initiated tablet reformulation studies and evaluated a capsule formulation used in a previous Phase I clinical trial. Further reformulation tests showed that there was likely an interaction between lactose and crospovidone in the formulation, in addition to a possible pressure effect, either compaction and/or compression. Although pre-development was for the capsules, the Catalent team found that the pump technology was also suitable for blowing/filling/sealing applications. .