Outsourcing

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

Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.

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

Inhalation drug delivery company Vectura announces new organizational structure to drive innovation, customer focus, and growth.

Quick approval pathways challenge teams to balance compliance with the need for speed.

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.

Catalent builds on its investment in cell and gene therapy development and manufacturing with the acquisition of MaSTherCell Global.

In replacing the retiring Paul Hegwood, Ricci Whitlow will oversee global clinical trial operations.

Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.

How to adopt win-win strategies and understand quality agreements for complying with cGMP when building strategic relationships with pharmaceutical contract research organizations.

CDMOs must consider challenges associated with the complexity of contract pharmaceutical manufacturing when approaching digitalization projects.

As cell and gene therapies become more prominent, industry is seeking the expertise and capabilities of outsourcing partners to ensure success.

The need for manufacturing speed inspires contract manufacturers to explore advanced processing technologies.

CDMOs and CMOs will continue to invest in biopharmaceutical services and facilities as the bio/pharmaceutical industry looks to biosimilars and personalized medicine.

Drug development contract services company PPD announces initial public offering.

FDA revised the guidance after industry feedback and to clarify CGMP requirements for outsourcing facility operations.

Karen Flynn rejoins Catalent as president of biologics operations; regional presidents named for US and Europe.

Catalent’s FlexDirect service offers sponsors multiple delivery options from a single inventory.

Phillips-Medisize has announced that it is expanding its current Global Innovation and Development (GID) site in Struer, Denmark, to include a dedicated manufacturing development and clinical build unit.

Catalent completes purchase of biologics fill-finish and oral solid dose facility in Anagni, Italy

Catalent’s planning service is designed to assist in evaluating needs for launching and maintaining clinical trials.

The acquisition expands Charles River’s scientific capabilities in cell therapy development.

Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.

Catalent and Ethicann Pharmaceuticals have announced a partnership aimed at developing a new combination pharmaceutical-grade CBD and THC product to treat MS spasticity using Catalent’s orally disintegrating tablet technology.

Spray drying is a versatile and rapid technique that can provide companies with a suitable and scalable option to improve the solubility and bioavailability of drug products.

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.

The companies announced a commercial supply agreement following FDA’s accelerated approval.

New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.

Lubrizol Life Science Health adopts new name and opens commercial manufacturing facility.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.