Contract Manufacturing, General

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.

Biotechnology company, Avacta Group, and clinical-stage oncology-focused biotech, ADC Therapeutics, have entered into a collaboration and option agreement focused on the development of potent Affimer-drug conjugates.

BioPharm International spoke with Marybeth Reynoso, senior director, early development strategic operations at PPD about the direction the industry is taking regarding the outsourcing of early development operations to contract research organizations (CROs).

Learning to think with the end in mind will help clients and their selected CRO to design and conduct the right studies.

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

BioPharm International spoke with Cindy Reiss-Clark, vice president, general manager, Biologics at West Pharmaceutical Services Inc., about the growing biologics market, specifically gene therapies, and how West is helping their clients prepare for these new trends.

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. 

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

Dual-sourcing and redundant manufacturing capabilities are crucial in a single-use supply chain strategy, but must be applied correctly.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

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

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

The expansion of the CDMO’s Skokie, IL facility includes additional refrigeration and freezer space.

Contract manufacturing organizations need to adapt to successfully overcome the specific challenges posed by complex therapies.

Belgium-based CDMO MaSTherCell will expand its European manufacturing capacity for cell and gene therapy products by setting up a new facility in Belgium.

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

Technology vendors are strengthening their positions in China as the nation emphasizes self-sufficiency in research, development, and manufacturing.

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

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.