Ramarketing news round-up 

In this week’s news, industry warming to US FDA quality reporting plan, Malaysia changes plant change reporting definitions and more.

Industry warming to US FDA quality reporting plan

CDMOs and the drug industry may be warming to a US FDA plan to collect quality metrics from pharmaceutical manufacturers.

In March the US FDA said it wanted to collect data from plants to try and head off shortages. 

In responses published this week both Pfizer and the Parenteral Drug Association (PDA) said they supported the flexibility of the proposed quality metrics program.

Malaysia rejigs rules on facility changes

Malaysia’s national drug regulator has updated its position on changes to manufacturing facilities that make sterile products.

According to a notice posted late last week, the agency has clarified its definition of a “type III” change – which is when production is relocated to a second plant or CDMO outside the country.

The document also revises the definition of a “type IV” change – when production is move to a second facility within the country –

FDA needs to develop AI/ML guidelines for device sector

The US Food and Drug Administration (FDA) should support use of artificial intelligence and machine learning (AI/ML) in medical devices says law firm Epstein, Becker and Green.

According to a report by RAPS the agency should focus on development of new standards and setting deadlines for AI/ML implementation for the benefits of CDMOs and device developers.

Also in the news

RAPS covered the progress being made by the current US FDA’s latest $3.6 billion budget request.

The European Pharmaceutical Review covered industry calls for support warning that rising materials costs are putting the availability of medicines at risk.

Pharmalot looked at the increasingly acrimonious debate about COVID-19 vaccine manufacturing rights and patent waivers.

Concerns are growing about the environmental impact that single-use bioprocessing technologies – which are becoming more widely used in the CDMO space – are having according to Contract Pharma.

Bakersfield looked at Tenaya Therapeutics completion of its Genetic Medicines Manufacturing Center in Union City, California. 

The US FDA could do more to promote generic competition according to an Op-ed by the SC-Brookings Schaeffer Initiative.

CDMO trends

Some developments of note in the contracting sector: 

Evonik is building a facility for pharmaceutical lipids at its site in Tippecanoe site in Lafayette, Indiana. The firm cited higher demand for lipid technology after the COVID-19 pandemic as a motivation

Belgian CDMO Exothera has teamed with LogicBio Therapeutics and Polyplus-transfection SA to develop a scalable AAV manufacturing platform.

Almac plans to invest €230 million to expand it operations, with £20 million earmarked for improvements to its campus in Northern Ireland according to the Irish Times. 

Batavia Biosciences has announced plans to expand its headquarters and R&D capacities in the Netherlands. The firm cited the rapidly growing biopharmaceutical market as a key target customer base.

ValenzaBio has hired ProBioGen for process development services. The new project is a continuation of successfully completed cell line development work that utilized ProBioGen’s proprietary technologies.

Ten23 has announced plans to expand manufacturing capacity at its site in Visp, Switzerland.