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

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.

In the latest issue of Tablets & Capsules, Bikash Chatterjee cites the factors driving growth in OSD manufacturing in the outsourcing markets. One is a focus on dosage formulations that simplify compliance for the patient,  a key concept of #patientcentricity. Other factors come in response to the COVID pandemic, as well as a renewed emphasis on oncology treatments. 

Pharmatech's Michael Cooper writes about an aspect that is easily overlooked by small start-ups and mature multi-product drug sponsors alike: verification that all commitments made to the FDA have been completed, and that evidence has been submitted to the agency. The devil is in the details... here are six points to consider to ensure your NDA / BLA is ready for the FDA.

The CPhI Annual Report 2021 refers to  a "golden age for discovery, technology, and growth," as 10 global experts weigh in on latest innovations in pharmaceutical and biopharmaceutical manufacturing. This roundtable podcast is a lively discussion on trends, including continuous manufacturing, and what is driving growth in the mammalian biomanufacturing sector.  

Pharmaceutical Technology spoke with Adam Lambert, PhD, vice-president of product & process development at Pharmatech Associates, about current regulatory considerations and best practices in developing combination products.

Mark Mitchell of Pharmatech, in BioProcess Online: "The ICH Q13 guideline adequately outlines the challenges and expectations of continuous manufacturing of drug substances and drug products. Most hurdles for implementation are not regulatory, but technological and procedural. Overcoming these hurdles lies with pharmaceutical manufacturers in establishing standard approaches for equipment design, control strategies, PAT instrumentation and validation, material diversion procedures, and RTRT. Proficiencies in these areas are applicable to both continuous and batch processing."

Analysis from six leading U.S. experts – following extensive interviews and data collection – provides an essential guide to near-term priorities, medium-term capacity constraints and longer-term shifts underway in the U.S. pharma market supply chain.

Bikash Chatterjee, Pharmatech Associates' CEO predicts a bright future for pharma manufacturing in terms of demand, growth, and new development.

Mr Chatterjee: “It’s going to be the most exciting 10 years for US pharma. There is no question about it. I think it’s going to be unbelievable in terms of the innovation we are going to see. This applies from new drugs and therapies to advanced manufacturing techniques for cell and gene therapies and continuous processing.”

A new eBook from BioProcess Online compiles recent assessments from the foremost FDA consultants and analysts in the space. Collectively, the insights they share shed light on the FDA’s go-forward strategy to maintain the regulatory tempo, while maintaining the stringent standards that have made it the world’s “gold standard” regulatory agency. 

"We believe the insight shared in this collection of content will help biopharma leaders refresh their regulatory expectations and strategies as the industry returns to ‘normal,' embraces a new norm, or lands somewhere between the two.” - Matt Pillar, Chief Editor, BioProcess Online.

Bikash Chatterjee of #Pharmatech Associates calls out five key elements to watch among the major strategic initiatives in the #FDA 2021 Focus Areas of Regulatory Science (#FARS):

- Patient-Centricity & Real-World Evidence

- Biomarker Research

- AI & Computer Modeling

- Advanced Manufacturing

- The Power of Data

Bikash Chatterjee points out that the FDA’s commitment to innovation goes beyond providing guidance alone. The agency supports the 

adoption of advanced manufacturing technologies (AMTs) and processes, recognizing that AMT subsumes a broad swath of production techniques, including:

• The integration of novel technology approaches;
• The use of established techniques in a new or innovative way;
• Applying production methods in a new domain where there are no defined best practices or experiences.

Allison Cacciatore of Pharmatech writes about the dual-pronged approach to consider to achieve delivery of a facility that operates at design capacity upon handover, namely the facility **and** the product.

The new normal created by the recent COVID-19 pandemic has created disruptions in many sectors of life sciences. Pharmatech's Wai Wong writes that, In the case of vaccine development, pairing SIA with digital twin modeling can provide invaluable insight into whether your equipment has the necessary capabilities to accept the process.

Pharmatech's Mary Lou Zett has mapped out the planning process for the development of a biosimilar from an analytical approach supported by nonclinical and clinical comparability studies, in a two-part article in BioProcess Online. 

In part one, she details the biosimilar development path. In the second part of the article discusses what--and when--to present research findings and how to prepare for your meetings with the FDA.

Identifying the right CDMO partner can be a complex undertaking, but lack of structure can lead to mistakes and lost development time. Recognizing that CMC and quality expectations will change as your program moves to commercial manufacturing is key to your assessment. 

In Outsourced Pharma, Pharmatech’s Brian Glass explains how new USP guidelines <1220> will affect CDMOs and drug sponsors. The quality by design (QbD) approach moves method development, qualification, and management away from an empirical framework to one that is based on scientific understanding — with methods that are well understood — as a product moves to commercial manufacturing.

Bikash Chatterjee writes about innovation in pharmaceutical manufacturing, and the ripple effect it has on industry. ..." initiatives such as reshoring, and a sharpened focus on ensuring the integrity of the strategic national stockpile (SNS), will be a springboard for the development and refinement of advanced manufacturing technologies.”

In a column in Clinical Leader, Pharmatech's Michael Cooper shares insight about how decentralized clinical trials using digital technologies benefit patients, drug sponsors, and investigators as they broaden the data collected to a larger diversity of patients across ethnic, racial, and socioeconomic lines and raise the overall understanding of the drug therapy.

Bikash Chatterjee, in the panel session at CPhI North America titled The Real Cost of Bringing Manufacturing Home: "So when you look at your supply chain risk exposure, you have to look at your total supply chain to be successful in reshoring these initiatives. It’s not just the API, not just the drug product, but all of the elements, all components associated with our ability to make and test and ensure the drugs are effective and safe." 

Moria Feighery-Ross and Wai Wong of Pharmatech outline the validation considerations that are key to the implementation and deployment of a “factory-in-a-box.” Where such modular factories are utilized, manufacturing capacity is limited only by the floor space to house them, which translates to reduced capital investment for scaling up and no lost time to construction.

Bikash Chatterjee, CEO for Pharmatech Associates, predicted that in the next four to five years, the industry will witness drug therapies emerge for one of the multi-modal disease states that have been incredibly difficult to gain traction on, such as multiple sclerosis or ALS.

He also predicted the application of artificial intelligence (AI), “whether it’s on the early precursor chemical synthesis processes, in the formulation development processes, or in the treatment algorithms” as a catalyst to explore new options—the ‘what ifs’ of discovery and development—very efficiently.

The world’s need for COVID-19 vaccines has rewritten the rules of drug development. Pharmatech CEO Bikash Chatterjee writes, in Life Science Leader's 2021 CMO Awards issue: "A data management plan is crucial to the ability to gather and use data from across the value chain. As drug sponsors extend the development and manufacturing enterprise to include CDMO partners, sharing access to relevant data affects time to market and simplifies program decision-making."

Michael Cooper reviews how a product approval within the EEA can be leveraged to support registration in new markets through the CMP. For products not approved in the EEA, sponsors can still request a CMP under Article 58.

The FDA supports manufacturers of products approved in the U.S. to obtain registration in new markets by issuing the appropriate export certificates and, in certain instances, will consider products not approved or still under review. 

In BioProcess Online, Pharmatech's Mary Lou Zett discusses how to prepare for your meetings with the FDA, in the context of biosimilar development.