Contract Development Services

Sterling Pharma Solutions has announced a £10 million (US$13.5 million) investment into process development and manufacturing capacity at its site in Dudley, UK.

Investing in formulation strategies earlier on in development will maximize the chance of success.

Dosage form priorities are shifting to focus on user-friendliness, leading to greater engagement with outsourcing partners earlier in development timelines.

Collaborative partnerships can foster success in formulation development projects.

The choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.

The CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.

The companies will utilize the Cocoon Platform for clinical point-of-care manufacturing.

The companies have entered into an agreement to develop processes for a novel immunotherapy protein.

Vectura has signed an agreement with Incannex Healthcare for the pre-clinical development of IHL-216A, an inhaled drug product for the treatment of traumatic brain injury.

Thought and foresight into method development stages can ensure costly errors and delays are avoided later on.

Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.

An integrated CMC provider can help smaller companies to streamline development timelines and reduce project management complexity when compared with multi-provider models.

The rapid and efficient delivery of innovative treatments through the COVID-19 pandemic has demonstrated the value of collaborations within the bio/pharma industry.

Outsourcing partners can provide a multitude of advantages in the development of drug delivery solutions, including those designed for targeted patient populations.

The right partner can help companies overcome key formulation challenges for biologic drugs.

More complex and challenging compounds require a more tailored approach to formulation strategies.

Contract service providers offer vital services to bio/pharma companies of all sizes. Establishing an effective working relationship and managing operations are key to avoiding compliance issues.

Catalent has unveiled plans to invest in a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France.

The acquisition will give the CDMO additional clinical filling options in Europe, which is expected to come online in 2021.

Lonza is making additional investments in its global particle engineering network for expanded capacity and specialized capabilities.

Demand for custom drug delivery solutions is increasing and bringing forth an exciting period of valuable, innovative development opportunities.

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

FDA approved hydroxychloroquine sulfate for emergency use as a treatment for some hospitalized patients with COVID-19.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.

Can investing in early formulation studies drive a new therapy successfully across the commercialization finish line?

Under the agreement, ERS Genomics will license its gene-editing technology to Aelian Biotechnoloy to support its commercial functional genomic screening platform.

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.