Feliza Mirasol is the science editor for 

Feliza Mirasol

In this exclusive Drug Digest video interview, Felicity Thomas and Feliza Mirasol, 

editors, interview experts in solid dosage development and manufacturing. Alex Trombley, oral solid dosage (OSD) process specialist/business development manager of Syntegon, runs through the benefits of continuous OSD production and key considerations for containment and operator safety, while Ali Rajabi-Siahboomi, vice president and chief innovation officer, and Gary Pond, global lead, authentication, both of Colorcon, highlight the importance of authentication at the dose level.

 is Syntegon’s Business Development Manager where he is focused on technical support, customer trials, and market development for Huttlin products in North. Alex is experienced in early phase formulation development, process identification, scale-up, and technology transfer and has worked extensively with continuous manufacturing, high shear granulation, fluid bed granulation, tableting, and coating.

 is the vice president and chief innovation officer at Colorcon, based at the Global Headquarter, USA. Rajabi-Siahboomi has held various academic positions in Nottingham and Liverpool JM Universities in the UK before joining Colorcon as technical director, responsible for Europe, the Middle East, and Africa in 2000. His main research interests are solid dosage form pharmaceutics, pharmaceutical technology with emphasis on oral drug delivery systems, solubility enhancement to improve bioavailbility, and consistency of drugs and bioequivalence formulations. He has published more than 300 articles, book chapters, abstracts, and patents and obtained his B.Pharm. and PhD in pharmacy from the University of Nottingham (UK).

 is the global lead authentication for Colorcon and is responsible for leading the overall strategy, business planning, and operational execution for Colorcon’s on-dose authentication business. Pond has more than 25 years of experience in product management, marketing, operations, and digital transformation, and he is an established leader in on-dose authentication. Prior to Colorcon, Pond held marketing and operational leadership roles at Sanofi, Merck & Co, Abraxis Bioscience, and IQVIA.

This episode of Drug Digest is sponsored by:

Drug Digest is a tech talk video series with the 

 editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Automating pharma and biopharma processes

Videos

Pharmaceutical Technology editors interview oral solid dosage development experts from Syntegon and Colorcon, with discussions centered on continuous OSD production, containment safety, and authentication at the dose level.

Drug Digest: Advancing OSD: Continuous Production Considerations and Dose-Level Authentication

In this exclusive Drug Digest video, Meg Rivers and Feliza Mirasol interview experts in cell and gene therapies and antibody-drug conjugates. Specifically, they discuss the factors that could influence an organization to pursue specific biomolecules for development; key considerations for scalability; capacity issues; trends; chemistry manufacturing and controls; and how to ensure consistency and reproducibility.

Lisa McDermott, Director of Process and Analytical Development Global Contract Manufacturing Services, MilliporeSigma, the US and Canadian Life Science business of Merck KGaA Darmstadt, Germany

: Lisa McDermott is the director of the process and analytical development department at MilliporeSigma in St. Louis, Mo., which is responsible for the development and transfer of custom projects into GMP manufacturing and testing. Her previous background includes 17 years with Monsanto as a synthetic organic chemist working on both agricultural and pharmaceutical projects, followed by seven years at Pfizer with a focus on determining analytical control strategies for GMP success. Over McDermott’s 30 years of experience in synthetic and analytical sciences, she has had the opportunity to contribute to many projects, ranging from discovery to full commercial.

Jasna Curak, Global Quality and External Collaboration Manager, Hoffmann-La Roche Ltd

: Jasna Curak is part of Roche Global Compliance and External Collaboration; regulatory intelligence for ATMPs; GMP considerations; currently working with ISPE ATMP community of practice; active in drafting position papers; and is a commenting lead for the global regulatory landscape. Previously, she was in production management in large-scale manufacturing facilities for vaccine manufacturing and a GMP maintenance lead, supporting a reliable and robust process integrated with strong quality infrastructure. She holds a master’s degree in molecular genetics from the University of Toronto, and a bachelor’s degree in biochemistry, molecular biology from McMaster University, Canada.

Welcome to this episode of Drug Digest, a tech talk with the 

 editors, who discuss with experts the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

In this exclusive Drug Digest video, experts from Roche and MilliporeSigma divulge factors that could influence an organization to pursue specific biomolecules for development.

Drug Digest: Development and Scalability of ADCs and CGTs

Oral solid dosage forms are a dynamic, ever-changing landscape, driven primarily by more highly potent new chemical entities (NCEs) that require particularly specific formulations. In this Drug Solutions Podcast episode, Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione, discuss how, in addition to NCEs, older, more established APIs are finding renewed life because these APIs are continually enhanced to have higher potency at lower doses, changing the way their formulation is handled. Looking toward the future, the bio/pharma industry is also tackling the issue of converting large-molecule (biologic) drugs into orally administered dosage, rather than parenteral administration, for increased patient compliance. Among the issues discussed are:

The latest developments in oral solid dosage technology and methodologies

What remains the biggest challenges in formulating APIs for oral solid dosage administration

How the industry is tackling the issue of enhancing bioavailability through better oral solid dosage formulations/technologies, etc.

Some “best-practice” approaches to formulating oral solid dosage products

, vice-president R&D and Regulatory Submission, LGM Pharma, joined LGM in 2020 to lead the company’s integrated R&D and regulatory submissions teams for CDMO clients. He has launched commercial products with several US and EU patents and handled submissions for NDAs, ANDAs, BLAs, and medical devices. Prior to joining Nexgen in 2015 to lead the R&D and Regulatory groups, Deepak was managing director at Actavis, chief scientific officer and vice-president of pharmaceutical development at PharmaNova, chief scientific officer and senior vice-president of pharma development at Holopack International, and associate director of Global Pharmaceutical Development and Technology at UCB Pharma. He earned his master’s in Pharmaceutics from Saugor University and his PhD and post-doctoral training from the University of Cincinnati in Pharmaceutical Sciences. He earned MBAs from Cornell University—in general business administration and finance—and Queen’s University.

, senior vice-president of Sales & Marketing, Hovione, graduated from the Chemical Engineering department at the Technical University of Lisbon, where he also obtained a PhD in chemistry in 2006. In 2007 he joined the Hovione R&D department as a scientist in the particle design discipline. The focus of his work was the application of particle engineering technologies to improve bioavailability of poorly water-soluble drugs. In May 2011 he was appointed the director of R&D Process Chemistry and was responsible for a group of dedicated scientists focused on the development and scale-up of chemical processes for the production of active ingredients. He has held several management responsibilities, including site general manager of Hovione operations in the United States and commercial-related functions. He is author of more than 15 scientific papers in peer-reviewed journals and book chapters, co-author in two patents, and an invited speaker in more than 10 international conferences.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode of the Drug Solutions Podcast, Feliza Mirasol, science editor, discusses the changing parameters for oral solid dosage forms as driven by APIs and new chemical entities with Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione. 

Drug Solutions Podcast: The Evolving Landscape of Oral Solid Dosage Forms

The evolution of technologies on the bioprocessing front is enabling an ability to perform continuous processing for biologic production. Although successes have been shown at small scale, challenges arise when translating continuous processes to large-scale good manufacturing practice (GMP) level. With the help of technological advances and innovative thinking, however, the potential to implement GMP-scale continuous bioprocessing is getting closer to reality. This article looks at real-world experiences of some companies that tested out the implementation of continuous manufacturing systems for GMP-scale biologics manufacture. 

Implementing Continuous Bioprocessing: From Theory to Practice

When referring to this article, please cite it as F. Mirasol, “Implementing Continuous Bioprocessing: From Theory to Practice," 

Articles

The struggle to implement continuous biomanufacturing at GMP level is slowly advancing.

Lyophilization remains an integral step in the manufacturing process for certain biotherapeutics, as was demonstrated with the COVID-19 vaccines. Lyophilization is also important in traditional biologic manufacturing and for emerging therapies. However, there remains inherent risk in subjecting these biomolecules through successive freeze-thaw cycles, which call for best-practice procedures to ensure that product viability and stability are maintained during the lyophilization process. Furthermore, questions have arisen about the long-term sustainability of current lyophilization techniques as the development of new biologic and emerging therapy drug candidates continues to grow.

Converting Injectable Therapies to Combination Drug-Device Products

Read this article in the Trends in Manufacturing ebook.

1. EC, “EU Legislation to Control F-gases,” ec.europa.eu, accessedJan. 14, 2022.

When referring to this article, please cite it as F. Mirasol, “Plan Early: Optimizing Stability During Lyophilization,” 

Pharmaceutical Technology Trends in Manufacturing

The need for sustainability and early considerations of a lyophilization strategy grow more pertinent on the back of growing biologics volume.

Plan Early: Optimizing Stability During Lyophilization

editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.

Steven Lynn, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates (RCA

), has 24 years of quality and regulatory compliance related experience, is an expert in Current Good Manufacturing Practices compliance related matters and has significant experience with other GxP quality compliance and regulatory issues.



Alexander Natz, Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

, advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective.


 editors, who interview experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

: Biopharmaceutical drug development and manufacturing

In this episode of Drug Digest, Pharmaceutical Technology editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.