Industry Proponents Make the Case for Continuous Manufacturing

Energy, space and API savings more than make up for the cost of switching from batch to continuous manufacturing methods, proponents say. So why not take a chance on it?

Industry proponents say continuous manufacturing produces better quality pharmaceutical products and at lower cost than those produced by batch processes. Sell the economic benefits to upper management, they say, and don’t be discouraged by the higher initial costs and perceived regulatory roadblocks.

Speakers at an American Association of Pharmaceutical Scientists (AAPS) meeting on continuous manufacturing of solid oral dose products attested to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Agency Leadership

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

More from Pink Sheet

Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.

England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

 

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.