Susan Haigney

Sustainability in Pharmaceutical Manufacturing

The pharmaceutical industry has been moving toward more environmentally friendly practices over the past decade. Regulators have also created sustainability requirements, especially in Europe.

“European regulations are particularly stringent on emissions and product lifecycle sustainability, and they have guided a lot of our initiatives such as a co-design, or carbon offset partnerships,” says Charles Ruban, president and CEO, Verdot.

Both small-molecule and large-molecule drug manufacturing have their own challenges, according to Ruban. Biopharmaceutical manufacturing is energy-intensive and creates material waste during production. Ruban says Verdot approaches the challenges of sustainable biopharmaceutical manufacturing by designing energy-efficient equipment that optimizes the use of material.

“We're partnering with suppliers committed to systemic sustainability, so our carbon-neutral initiative reflects the commitment of overcoming those models while enabling appliances to globally reduce their environmental footprint,” says Ruban.

Click the video above to watch the interview.

Videos

Pharmaceutical Technology® spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceutical manufacturing.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

The European Medicines Agency (EMA) announced on Jan. 10, 2025 that it is prepared for the implementation of the health technology assessment regulation (HTAR) that comes into effect on Jan. 12, 2025 (

) (1, 2). The HTAR accelerates and widens access to new medicines in the European Union and creates a framework for the assessment of certain high-risk medical devices. The allows for cooperation between regulators in the evaluation of the risks and benefits of medicines, expanding the cooperation between EMA and health technology assessment (HTA) bodies.

New regulations will start with new active substances for oncology products and advanced therapy medicinal products (ATMPs). Rules will then be expanded to orphan drug products in January 2028 and then all centrally authorized products in 2030.

The agency has been working with the European Commission (EC), EU Member States, and stakeholders from industry, healthcare, patients, and academia in preparation for its support of the regulation. EMA’s support of the HTAR will include helping to conduct timely joint clinical assessments (JCA) by the HTA Coordination Group (HTACG) by providing relevant information from its own regulatory assessments. The agency will also collaborate with the HTA Coordination Group in joint scientific consultations to provide scientific advice to technology developers and generate evidence to satisfy regulators and HTA bodies. EMA will also exchange information on upcoming applications and technologies for planning purposes.

"EMA welcomes the new HTA regulation and is ready to do what it takes to support the European Commission and the Member States in its successful implementation,” said EMA’s Executive Director, Emer Cooke, in the press release. “While our role is supportive, the new regulation will enable our collaboration across decision-makers reinforcing efforts to improve access to medicines for all patients in the EU. In our network strategy to 2028, facilitating the path to accessibility of new medicines for patients is a priority and the framework for cooperation and the exchange of information between regulators and HTA bodies provided by the new rules will help galvanize our efforts."

EMA has a legal obligation to notify the EC, which is the secretariat to the HTACG, and ensure that procedures are being followed and work is done is a timely and transparent way when marketing authorization applications are received that fall into the scope of JCA. HTACG estimates in 2025 it will need to conduct 17 JCAs for cancer drugs and eight JCAs for ATMPs. EMA also must provide information from ongoing regulatory assessments, details of which will be developed by EMA’s committee for human medicines and the JCA subgroup.

The first request period for JSC will be launched by the HTACG in February 2025, and developers can request parallel JSC with EMA.

“The future processes for parallel JSC have been built based on experience gathered since the initial piloting in 2008 and the iterations of process improvement performed over time. This year, the HTACG is planning to initiate five to seven joint scientific consultations for medicinal products and one to three joint scientific consultations for medical devices,” EMA stated in the press release.

EMA. New EU Rules for Health Technology Assessments Become Effective. Press Release. Jan. 10, 2025. 

https://www.ema.europa.eu/en/news/new-eu-rules-health-technology-assessments-become-effective

EU. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance), Dec. 15, 2021. EUR-Lex. 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282

Articles

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

EMA Prepared for Health Technology Assessment Regulation Implementation

TOP NEWS on grunge world map | Image Credit: © Sean K - © Sean K - stock.adobe.com

This story has been updated to include a comment by Glenn Wright, president and CEO of the Parenteral Drug Association.

An email communication, dated Jan. 10, 2025, released by FDA’s Center for Drug Evaluation and Research (CDER), announced the retirement of CDER Director, Patrizia Cavazzoni, effective January 18.

Cavazzoni joined FDA in 2018 as deputy director of operations in CDER and also served as acting principal deputy commissioner of Food and Drugs briefly in 2019. She was made director of CDER in 2021. Prior to working with FDA, Cavazzoni spent several years working in the pharmaceutical industry in the areas of clinical development, regulatory affairs, and safety risk management (1).

In a letter to her CDER colleagues announcing her retirement, Cavazzoni praised her team for how it handled the COVID-19 pandemic and the growth the center has shown in her years as director (2).

“While I could spend a lot of time enumerating our achievements, I want to highlight our biggest success: our people and our culture,” Cavazzoni said in the letter. “As I leave CDER, I can say with confidence that the Center is at its strongest. We have hired and retained record numbers of the best scientists and professionals. We have built a cohort of world-class managers and executives who are solidly at the helm of our organization and will continue to lead CDER. And most important of all, we created a culture that fosters respect for one another, inclusion, accountability, and diversity of thought and life experience. Our culture is what makes us strong and resilient, and it’s the foundation of what we have accomplished and will accomplish in the future.”

As of the time this article was written, FDA has not yet announced a replacement for Cavazzoni. Her predecessor, Janet Woodcock, was CDER director from 1994 to 2004 and then again from 2007 to 2021 (3).

®, Glenn Wright, president and CEO of the Parenteral Drug Association (PDA), said the following about Cavazzoni's retirement: 

“On behalf of PDA and our many industry members worldwide I thank Dr. Cavazzoni for her work as the CDER Center Director within FDA. Her efforts to move the industry and FDA forward to better serve patients is much appreciated. Communication between FDA and Industry is an essential part of ensuring expectations are well understood and concerns and issues raised. Her openness, and that of the Center she leads, to meet with Industry on topics of importance, speak at conferences and attend stakeholder meetings has been very helpful in this rapidly changing world.”

FDA. Patrizia Cavazzoni, M.D., Director–Center for Drug Evaluation and Research. FDA.gov. April 12, 2021. 

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/patrizia-cavazzoni

CDER Trade Press. CDER Director Patrizia Cavazzoni to Retire from FDA. Email Correspondence. Jan. 10, 2025.

FDA. Janet Woodcock, M.D. FDA.gov. Feb. 1, 2024. 

https://www.fda.gov/about-fda/fda-organization/janet-woodcock

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

Cavazzoni Retires as CDER Director

FDA published a draft guidance document on Jan. 2, 2025 that provides considerations for complying with 21 

) 211.110 (1). This specific section of the CFR focuses on production and process controls for sampling and testing of in-process materials and drug products. The guidance, 

Considerations for Complying With 21 CFR 211.110, Guidance for Industry, Draft Guidance, 

applies to human drug products and biologics, but not to the manufacture of APIs. The guidance document also discusses how process models can be incorporated into commercial manufacturing control strategies.

Batch uniformity and drug product integrity current good manufacturing practice requirements state that manufacturing processes must be designed and controlled to ensure that in-process materials meet predetermined quality requirements. In the document, FDA states robust product and process development are crucial for establishing and maintaining control strategies throughout the product’s lifecycle so that quality attributes are obtained.

“To ensure conformance to drug product quality requirements, the manufacturer should identify which critical quality attributes and in-process material attributes to monitor and control,” FDA states in the document (1). “Section 211.110 allows flexibility in the in-process controls, and testing, or examinations that are employed to ensure that processes deliver in-process materials and drug products with the appropriate quality attributes. To ensure that drug products have the properties that they are represented to possess, the in-process materials used throughout the manufacturing process should be of consistent quality.”

In addition, the guidance details quality considerations for drugs manufactured using advanced manufacturing technologies (AMTs). “All manufacturers, regardless of whether they are using advanced manufacturing, should apply a scientific- and risk-based approach to controlling processes and ensuring drug product quality,” FDA states in the guidance document (1). “This approach should be based on robust product and process understanding. Manufacturers must maintain the process in a state of control over the life of the process to ensure drug product quality, even as materials, equipment, production environment, personnel, and manufacturing procedures change. Planning and executing a system that monitors process performance and drug product quality helps ensure that a state of control is maintained. An effective monitoring system helps maintain a state of control in multiple ways, which include helping manufacturers: ensure that processes and controls are continuously capable of producing a drug product of desired quality; and identify areas for continual improvement.”

Additional guidance on advanced manufacturing was also published by FDA in January, explaining requirements for those in industry that wish to participate in the agency’s Advanced Manufacturing Technologies Designation Program (2). The Advanced Manufacturing Technologies Designation Program was required under section 506L of the Federal Food, Drug, and Cosmetic Act to provide a framework for those requesting designation of a drug manufacturing method as an AMT. The program provides early interaction opportunities before application submission as a way to encourage adoption of AMTs (3).

Considerations for Complying With 21 CFR 211.110, Guidance for Industry, Draft Guidance

https://www.fda.gov/media/184825/download

Advanced Manufacturing Technologies Designation Program, Guidance for Industry

 (CDER, CBER, December 2024).
3. Haigney, S. FDA Publishes Final Guidance on Advanced Manufacturing Technologies. 

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

FDA Releases Draft Guidance on Sampling and Testing of In-Process Materials and Drug Products

In an interview with Pharmaceutical Technology Roger Viney from ICE Pharma highlights the importance of sustainability for the bio/pharma industry and some important future considerations for companies.

Creating a Sustainable Approach

Sustainability in the pharmaceutical industry has increased in the past few years as a significant initiative for regulators and many pharmaceutical companies. Sustainability practices may include investment in renewables, zero emission buildings, and greener manufacturing practices (1). ICE Pharma has adopted a sustainability strategy that includes fighting illness through product innovation, caring for people, accelerating sustainable operations, and building strong relationships (2).To gain more perspective on sustainability in pharma, 

spoke withRoger Viney from ICE Pharma about what pharmaceutical companies should consider when developing a sustainability strategy.

Viney stresses that the healthcare industry, which is responsible for approximately 5% of global emissions, must be aware of the impact the industry has on the environment. “I think it's important to recognize that what we manufacture is biologically active,” says Viney. “So, in that case, it has a bigger environmental impact than some other products. I think in terms of the regulations that we have to comply with, you know, or the quality compliance regulations, I think the pharma industry is relatively slow to change, and we're slow to introduce new manufacturing technologies. We have difficulty adapting to new technologies which would lower our environmental impact. So, I think we've been slower than we would have liked. It's the nature of our industry. But I think, of course, there's a very big expectation from our customers, whether it be governments, businesses, or patients, that we do make progress in this area.”

Sustainability in the Pharmaceutical Industry

 (accessed Dec. 16, 2024). 
2. Lavery, P. 

ICE Pharma Touts Fully Recyclable Booth at Its CPHI Milan Exhibit

Roger Viney, PhD, is the chief commercial officer for ICE Pharma and is responsible for the global commercial functions. Roger has a 30-year career, starting in R&D and then moving across to sales, marketing, key account management, and business and product management for the pharma market.

FDA published a final guidance on Jan. 2, 2025 for those interested in participating in the agency’s Advanced Manufacturing Technologies Designation Program, which was developed to facilitate drugs manufactured using advanced manufacturing technologies (AMTs). The guidance, 

Advanced Manufacturing Technologies Designation Program

, is the final version of the draft document issued on Dec. 13, 2023.

Early adoption of AMTs that improve the reliability and robustness of manufacturing processes is encouraged by FDA. AMTs can reduce drug development time and may increase the supply of critical drugs, according to the agency. FDA defines “advanced manufacturing” as an “an innovative pharmaceutical manufacturing approach or technology that has the potential to improve the reliability and robustness of the manufacturing process and supply chain and increase timely access to quality medicines. Advanced manufacturing can integrate novel technological approaches, use established techniques in an innovative way, or apply production methods in a new domain where there are no defined best practices or experience” (1).

The Advanced Manufacturing Technologies Designation Program was required under section 506L of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide a framework for those requesting designation of a drug manufacturing method as an AMT. The program provides early interaction opportunities before application submission as a way to encourage adoption of AMTs.

The guidance document details FDA’s Advanced Manufacturing Technologies Designation Program and provides the eligibility criteria for AMT designation. The submission and assessment process for requests is also provided in the document, as well as the benefits related to drug development and application assessment. Details about key concepts for program utilization are available in a Q&A section of the guidance.

“Before submitting an AMT designation request, persons or organizations seeking designation of a method of manufacturing as an AMT (hereinafter requestors) should familiarize themselves with the data requirements described in section 506L of the FD&C Act, the recommendations outlined in this guidance, and other publicly available sources of product development information,” FDA states in the guidance. “Any technology can be considered for AMT designation provided that the technology meets the eligibility criteria described in section 506L(b) of the FD&C Act, the requestor has sufficient data and information to demonstrate eligibility, and the technology is mature enough to consistently and reliably manufacture product in the context of use for which AMT designation is sought.”

Request for AMT designation should include a brief description of the method and why it is a novel method; the context in which the AMT will be used; a description of how the method meets criteria established in section 506L(b) of the FD&C Act; potential regulatory, technical, or other challenges with implementation; anticipated timelines for drug development using the proposed AMT; among other requirements.

“FDA acknowledges that requestors who are not also applicants may not have data about a specific drug to include in their AMT designation request,” the document states. “In these cases, FDA recommends that requestors include data generated using a model drug to provide the agency with a clear understanding of the proposed AMT’s parameters, limitations, and context of use.”

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.