Contract Manufacturing, General

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.

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

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.

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

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

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

To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.

CDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.

Industry experts share their top outsourcing tips from both the perspective of companies offering outsourcing services as well as for companies looking to outsource.

The author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.

Understanding both the challenges and solutions of aseptic manufacturing.

Optimizing the use of partners for clinical trials depends on selecting the right contractor.

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.

MilliporeSigma announced the opening of its second Carlsbad, California-based facility, which doubles production capacity to support commercial and industrial manufacturing of viral vectors.

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.

AMRI reinforces positioning as a CDMO with name change and acquires the formulation and fill/finish company, Integrity Bio, and biologics company, LakePharma.

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 expected growth of the global bio/pharmaceutical market is pushing for the continued evolution of the CDMO arena.

As the RNA therapeutic market grows, contract manufacturing services for GMP-grade RNA are in demand and expected to continue on an upward trajectory.

The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.

Human error at an Emergent BioSolutions facility cited as cause for the loss of a large batch of COVID-19 vaccines.

Outsourcing increases as the industry balances development and manufacturing of both COVID-19 treatments and non-pandemic-related medicines.

Cytiva is adding process development, media and assay development, and contract development services at its facilities in Korea, Japan, Sweden, and the UK.

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS).

Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.

Sterling Pharma Solutions has signed a deal with Moleculin Biotech to support the development of WP1122, a potential COVID-19 treatment.

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.