Outsourcing

AGC Biologics has broken ground on a new multipurpose facility in Copenhagen, Denmark, that will increase capacity.

Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.

Curia plans to expand the site’s commercial capabilities with this move.

Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.

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.

Investments, biologics, and the impact of COVID-19 will continue to shape the bio/pharmaceutical outsourcing industry for the near term.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

There are some key questions that should be asked by both the sponsor company and the outsourcing partner before undertaking a method development project.

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

Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.

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.

Manufacturers seek more sustainable options for temperature-controlled packaging.

CDMO Idifarma has launched a new service aimed at delivering an accelerated pathway for complex drugs.

Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.

CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.

The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.

WuXi STA’s Delaware campus will contain clinical and commercial manufacturing capabilities for small molecules and novel molecular modalities.

Developing bioassay methods requires a new approach for cell and gene therapy drug development.

CDMO Yposkesi will increase its current gene therapy vector capacity through French government’s “Plan de Relance” scheme.

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.

Centrient started production at its new statins API manufacturing unit in Toansa, India.

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.

VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

MedPharm’s new facility for process development and small-scale manufacturing is in North Carolina, near its existing R&D center.