Contract Manufacturing, General

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.

Fujifilm allocates production volumes for COVID-19 treatments in 2021 at its Denmark facility.

But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.

Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.

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

CMOs and CDMOs expanded their services and facilities in 2019 and early 2020.

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

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

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.

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