Contract Manufacturing, General

The partnership provides Sarepta with capacity and manufacturing slots for GMP-grade plasmid production for its micro-dystrophin Duchenne muscular dystrophy gene therapy program, as well as plasmid capacity for future gene therapy programs.

The Massachusetts site, formerly associated with an affiliate of Shire, is Rentschler Biopharma’s first facility in the US.

The company has brought a second stream of high-throughput GMP peptide manufacturing online.

CMOs and CDMOs made investments in new and expanded facilities and services in the last quarter of 2018.

The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.

According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.

The new facility will include comprehensive mammalian process development and manufacturing capabilities.

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

The contract development and manufacturing organization expanded its analytical chemistry suite and added a new office in Boston, MA.

Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.

More than 120 healthcare organizations plan to bring competition to generic drug market.

The company is certified as a manufacturer of pressure vessels and components for use in China.

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

The API and drug product provider will invest £375,000 (US$493,000) in additional nuclear magnetic resonance (NMR) instrumentation at its headquarters in Craigavon, UK.

This article highlights 15 years of changes in biopharmaceutical manufacturing.

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.

Madison Dearborn Partners will acquire a majority ownership position in CDMO Alcami.

The company has begun expansion efforts for its process-development capabilities and laboratory infrastructure.

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Early adopters are benefiting from lower costs and increased productivity.

Developments and investments in single-use systems advance upstream biomanufacturing.

A review of the latest investments in facilities, equipment, and acquisitions by biopharma contract service providers.

A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.

Research suggests that working with a single contract partner can reduce development time and improve economics.

Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.

The companies will be integrated to form the newly-branded AGC Biologics, which will specialize in customized contract development and manufacturing organization services for the scale-up and cGMP manufacture of protein-based therapeutics.

The contract development and manufacturing organization has invested £30-million (US$42 million) at its Dundalk, Ireland site to offer expanded clinical trial services.

The company relocated its headquarters to Riverview, Florida.

KBI Biopharma's acquisition of Elion Labs expands KBI's biophysical and analytical characterization capabilities.