Process Development

Dissolution testing is experiencing a refresh thanks to a variety of market drivers.

As we reach further afield in the molecular universe, we encounter new types of problems to resolve.

Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.

Flexible and efficient methods are needed for biopharmaceutical manufacturing.

Digital maintenance solutions can help visualize the value and key activities provided by the equipment vendor from inception to utilization.

Developers need to consider key challenges when approaching accelerated formulation strategies to ensure success.

Noema Pharma announces first patient dosed in its Phase IIb clinical trial of mGluR5 inhibitor NOE-101 in trigeminal neuralgia.

Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.

Experience is an invaluable asset for outsourcing partners, particularly as more challenging method development services are in demand.

Shifting demands from industry innovators is leading to an increased need for flexible and agile outsourcing partners offering broad and integrated models.

A new focus on speed to market creates challenges for facility design and construction.

Genezen has opened its new process development and analytical lab for viral vector production.

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.

Ajinomoto and its subsidiary company, Ajinomoto Genexine, have partnered with Insilico Biotechnology to accelerate and improve process development and production of biologics using digital twin technology.

Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

Alternatives to animal testing and in-vivo assays are occurring as a result of recent scientific advances.

According to Charles River Laboratories, when asked how long it takes for a drug to be developed and approved for market in the United States, only 10% of 1,500 Americans polled correctly estimated that it takes between 10 and 15 years.

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.

The companies collaborate to develop and commercialize ARV-471, an investigational oral PROTAC (proteolysis targeting chimeras) estrogen receptor protein degrader.

Modeling the manufacturing process benefits both development and operations.

The US federal government awarded new funding to the National Institute for Innovation in Manufacturing Biopharmaceuticals, including funding under the American Rescue Plan that will be used to advance vaccine manufacturing.

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

The collaboration continues as the companies design bioprocess impurity reagent sets to detect residual HCP from HEK 293 cells.

Particle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.

A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.

What can the biopharma industry learn from its rapid response to the COVID-19 pandemic?