Agnes Shanley

Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

FDA Commissioner Scott Gottlieb and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, expect shortages to ease within six months. Although recycled solvents and materials are a prime concern, questions remain about the sources of contamination.

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

In January 2019, a temporary measure reopened the US government until Feb. 15, 2019, allowing FDA to resume full operations. Failure to find a permanent solution could have dangerous ripple effects on patient safety and innovation, says Jim Nolan, CEO of InClinica.

Radha Iyer, vice-president and head of Quality and Scientific Affairs, Global Developed Markets, Dr. Reddy’s Laboratories, discusses new initiatives at the company.

Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.

When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect.

This year promises to bring more focus on risk management and building a quality culture, says consultant Susan Schniepp.

Core functions and those funded by FY 2018 user fees are continuing, and 59% of the Agency’s staffers are being retained.

Success depends on supplier communication and transparency, but it’s up to buyers to demand the right information and to look at the vendor’s overall business goals.

Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.

By reducing the number of assays needed and allowing product quality attributes to be measured end to end, MAM promises to allow users to gain product and process understanding much sooner than they could in the past, and to ensure quality and safety in a more efficient, streamlined way, throughout the product life cycle.

Rather than isolating the user in a virtual world, mixed reality allows contextualized data to be shared in real time, improving assays, standard operating procedures, workflows, and overall tech transfer.

Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.

While recognizing the unsung work of scientists in corporate research and development, the Galien Awards remind the industry of its priorities: patients and future patients within the global community.

More-and earlier-interaction between R&D and payers will be essential if innovative therapies are to become more accessible for patients, and more profitable for manufacturers, said panelists at the 2018 Galien Foundation Forum.

Experts share best practices, and war stories, for a crucial but often underappreciated part of drug development.

New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.

Biotechnology developers should be aware of subtle differences between the way that European and United States patent authorities approach monoclonal antibodies.

Cost and IT practices may be holding back progress.

Audits by independent experts promise to ease the burden that customer audits can have on suppliers, while ensuring drug manufacturers that ingredients meet strict cGMP standards.

Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

Increasingly complex trial protocols have added to IMP manufacturing challenges.

As counterfeiting, API manufacturing issues, and illegal diversion increase vulnerability, could dispensers and even patients play a greater role in securing the pharma supply chain?

Sample preparation-specifically, API extraction and dilution-can introduce errors. Use of best practices and automation can reduce variability.