Outsourcing

Pre-clinical immunization studies of iBio’s SARS-CoV-2 VLP candidates are being performed by Texas A&M.

AzarGen’s biosimilar, made in iBio’s plant-based system, will be compared to the original molecule in pre-clinical studies.

Belgian-based bioprocessing provider, Univercells, has launched a CDMO, Exothera, that will support developers of cell and gene therapies through process development and production of viral vectors.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.

Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.

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

The need for lyophilization services is growing as a burgeoning pipeline of new biologics matures.

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

Technology and capacity investments create opportunities in the cell and gene therapy arena for CDMOs and biopharma alike.

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

Contract partners must help innovator biotechs 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.

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

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.

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.

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

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

The innovative spirit of biotech startups is a driving force behind the development of new therapeutic products, but building a successful biopharmaceutical company from the ground up has its risks and challenges.

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

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

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

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

Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

The new services provide rapid production of antibody drug conjugates (ADCs) for best candidate selection.

BioPharm International spoke with Marybeth Reynoso, senior director, early development strategic operations at PPD about the direction the industry is taking regarding the outsourcing of early development operations to contract research organizations (CROs).

Learning to think with the end in mind will help clients and their selected CRO to design and conduct the right studies.