Pharmatech Associates articles: technical expertise for the regulated life science industry

Pharmatech Associates’ Richard Steiner describes the main drivers of competitiveness, specific needs, and a value chain analysis for each market segment that benefit from adopting pharmaceutical continuous manufacturing (PCM).

Lawrence De Belder of Pharmatech Associates talks about the strategic advantages of continuous manufacturing in modern pharma manufacturing, in this video published in Contract Pharma. 

Sustainability programs are most commonly deployed under the umbrella of Environmental, Social and Governance (ESG) frameworks intending to address the larger issue of being a good corporate citizen, and ESG standards have trended upward. A record $649B was poured into ESG-focused funds worldwide in 2021.1 With stakeholders putting money into companies with sustainability plans in place, more businesses are prioritizing ESG programs. Looking closer at the ESG challenges in pharma, several areas emerge: 

• Reducing waste 
• Cutting carbon emissions and greenhouse gas pollution 
• Reducing pharma in the environment through multiple vectors 
• Energy and water consumption, including fossil fuel usage rates 

Allison Cacciatore of Pharmatech Associates writes in Outsourced Pharma that the cost-effectiveness of continuous manufacturing is realized through ease of processing, continuous monitoring, and the reduction in manual operations that contribute to a streamlined process and reduced footprint compared to separate unit operations. Manufacturing in this way results in lower operating costs and less product loss throughout the manufacturing process.

Stephanie Gaulding’s new guest column in Outsourced Pharma discusses CDMO assessment with a checklist that considers human dynamics.

With the right kind of checklist, Stephanie Gaulding shows how to construct an agreement between outsourcing partners that favors fluid communication and alignment of business objectives — crucial for a fruitful sponsor-CDMO relationship that diminishes overall risk for both.

Ahead of a special continuous manufacturing session at CPHI Frankfurt with Lawrence De Belder of Pharmatech Associates, 

Bikash Chatterjee spoke with Chemicals Knowledge Hub (CKH) on how the sector will change.

Stephanie Gaulding’s new column in Outsourced Pharma shares an operating model to help drug sponsors calibrate oversight of CDMO and CRO partners according to the details of each relationship in key areas of risk management, change management and interactions.

She notes that oversight plans need to be readily available to both parties throughout the engagement, to allow review and adjustment of the original approach.

Pharmatech's Brian Glass outlines the benefits of the enhanced approach to analytical procedure development described in the ICH Q14 new draft guidance, in a column in Outsourced Pharma.

sponsors should consider the pre-IND meeting as an essential step in the pharmaceutical product development lifecycle. This is when the sponsor presents their proposed product development plan and regulatory strategy to FDA and supports it with available safety and efficacy data. Early dialogue is important.

What are the advantages, benefits, and challenges of continuous manufacturing of oral solid-dosage drugs? Jennifer Markarian, manufacturing reporter at Pharmaceutical Technology discusses the evolution of continuous manufacturing with Lawrence De Belder, executive consultant at Pharmatech Associates, a USP company.

Advancements in medical device and ancillary technologies are leading to significant improvements in the new combination therapies available to patients. Adam Lambert of Pharmatech Associates explains that it's critical to get buy-in from regulatory authorities early in the development process to establish meaningful specifications for these complex products.

Interview with #Pharmatech Associates’ Richard Steiner on the value of pharmaceutical continuous manufacturing (PCM) - PharmTech | @scoopit http://sco.lt/...

Mike Cooper’s new column in Cell & Gene discusses how the U.S. FDA and the European Medicines Agency (EMA) approach cell and gene therapies, including the additional reimbursement approval step required in the European Economic Area (EEA).

When comparing requirements to obtain approval for cell and gene therapies between the FDA and the European Medicines Agency (EMA), one is struck by the variance in terminology. However, sponsors face similar challenges in both markets.

Capitalizing on the high-potency, high-performance HPAPI market requires navigating a host of safety and regulatory issues.

Up to 25 percent of all drugs are classified as highly potent, with HPAPIs in development for targeted treatments in oncology, metabolic disorders, and autoimmune diseases. Bikash Chatterjee of Pharmatech brings insight on HPAPIs in precision medicine and the advancements in manufacturing and operations necessary to handle highly potent compounds safely to meet rising demand.

Jennifer Markarian, manufacturing editor of Pharmaceutical Technology, interviewed Wai Wong and Moria Feighery-Ross of Pharmatech Associates among other experts about the demands for faster time-to-market and flexible changeovers that manufacturing expansion puts on validation to inform her article “Streamlining Equipment Quality and Flexibility,” published in Pharmaceutical Technology, November 2022, Volume 46, Issue 11.

In a new column in Med Device Online, Caitlin Bancroft of Pharmatech Associates makes the case that a Q-Submission is a valuable opportunity to engage with the FDA, well worth the time and effort leading up to filing a marketing authorization submission for a medical device.

She writes that going through the Q-Submission process allows a medical device sponsor to gain FDA insight and provides a preview of a coming submission that will lead to quicker review times and fewer post-submission requests for information. 

The current issue of Specialty Chemicals Magazine features an interview with Stephanie Gaulding, to coincide with the CPhI North America in-person event at the Pennsylvania Convention Center this week (May 17-19, 2022).

A little flexibility in approach will improve consistency and enable pharma partners to perform to their optimum level. Ahead of her presentation on ‘How to Build a ‘Framework for Managing Your Outsourcing Partner’ at CPhI North America, Andrew Warmington spoke with Stephanie Gaulding, executive director of regulatory compliance at Pharmatech Associates.

Leading up to CPhI North America, Outsourcing Pharma interviewed Bikash Chatterjee of Pharmatech Associates on next steps for continuous manufacturing initiatives in the U.S. Chatterjee will be offering insights and predictions during "Continuous Manufacturing: What's Driving Adoption?," a panel session on May 17 at 2:30pm EST at CPhI North America 2022. The conference is a "smart" event, held online May 9-27, and in Philadelphia May 17-19. 

Stephanie Gaulding explains important aspects of the latest revision to the U.S. Quality System Regulation (21 CFR Part 820) to help understand country-specific requirements, terminology, and the impact on FDA inspections going forward for medical devices and combination products.

Due to the complexity of combination products, drug sponsors may receive several deficiencies and compliance observations—known as 483 observations in the United States. Part two of Adam Lambert’s article on combination products clarifies important guidance points to help mitigate the risk surrounding validation of methods and to ensure a robust marketing application.