Contract Manufacturing, General

Does the pharmaceutical industry have adequate access to contained equipment, facilities, and infrastructure for the manufacture of highly potent APIs?

Key considerations when searching for an analytical service provider include workflow, hardware, and regulatory support.

Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma. 

Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

CDMO, Vibalogics, has revealed that it will be acquired by a private equity firm, Ampersand Capital Partners.

Temporary power, HVAC, and oil-free compressor systems provide flexibility and control for pharmaceutical manufacturing facilities.

The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.

The investment will increase patient-centric dosage form manufacturing capabilities at Catalent’s Winchester, KY, facility.

Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.

A $100-million investment will expand a range of the CDMO’s service capabilities and offerings.

Process optimization improves process mass intensity, reduces environmental impact, and improves cycle time for bio/pharmaceutical processes.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.

A monoplant may offer greater supply security and flexibility for specialist medicines.

Recipharm has received ISO 45001 certification for its Wasserberg facility in Germany as a result of the facility’s program to enhance sustainability and safety.

Outsourcing of analytical testing and processes can help bio/pharmaceutical companies expand their product profiles.

Suppliers set the tone for 2019 with strategic expansions, investments, and acquisitions.

Only careful planning can prevent problems that stem from differences between a sponsor’s and a CDMO’s equipment, practices, and culture. This article highlights best practices and case studies.

The company will invest $4 million to increase topical and transdermal formulation development and performance testing services at its Durham, NC, facility.

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

The $252-million acquisition is expected to strengthen Cambrex’s position as a small-molecule CDMO across the drug lifecycle.

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.

Catalent will expand primary packaging capabilities and commission an automated, high-speed bottling line for clinical packaging of capsules and tablets.

With the $252-million acquisition of contract development, manufacturing, and testing organization Avista Pharma Solutions, Cambrex will enter the market for early stage small-molecule development and testing services.

In preparation for the upcoming US Drug Supply Chain Security Act deadline, Metrics Contract Services has expanded serialization capabilities at its oral solid-dose commercial manufacturing site in Greenville, NC.

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

Ardena has moved into its expanded headquarters, located in Gent, Belgium, as a result of continued growth.

Pharmatech Associates International Contracting and Services is a new company headquartered in Doha, Qatar, that will provide product development, facility design, and construction for high quality pharmaceutical and biotech products at low cost.