Outsourcing

CMO growth is focused on analytical testing, toxicity testing, and fill/finish operations.

In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

Agilent’s $725 million investment is designed to double its capacity to produce APIs.

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

In the all-too-common debate over building lab facilities versus outsourcing, the best strategy may be the middle ground: licensing.

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.

In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.

The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.

Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

Integrated project delivery can fast-track delivery targets by eliminating the waste involved in traditional approaches to project set-up and execution.

A thorough understanding of both regulatory requirements and study challenges can help develop and validate the appropriate methods for a bioanalytical study program.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

Automation of pharmaceutical packaging saves costs and time, say contract packagers.

How dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.

Kindeva’s acquisition of iPharma will increase the company’s inhalation formulation outsourcing capabilities.

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

Following the acquisition by Altaris Capital Partners, Johnson Matthey Health has rebranded as Veranova.

One can use modeling methods to generate data and shorten development timelines in preclinical studies.

Having a clear clinical strategy early on can shave time off overall development projects.

When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

Through the Thermo Fisher Scientific and LabShares Newton partnership, life science startups can accelerate early-stage discovery and development with shared lab spaces.

PerkinElmer has expanded its genomics testing services with the launch of its ultrarapid whole genome sequencing.

Lonza and Israel Biotech Fund form a two-year agreement to support accelerated development and manufacture of biologics and small molecules.