Meg Rivers is the former senior editor for 

Meg Rivers

In this Drug Digest episode, Chris Spivey, editorial director, and Meg Rivers, senior editor, dive into APIs, excipients, and formulation advances, specifically pairing the right APIs and excipients for optimizing formulations.

Nitin Swarnakar, manager NA applications lab (pharma solutions), BASF

, is a formulation scientist with more than 14 years of combined (academic research/training/industrial) experience and a strong track record of publications primarily focused on various formulation aspects of small, peptide, and protein molecules for oral and parenteral applications.

Gregory Lane, PhD, senior principal investigator, Bristol Myers Squibb

, started working at Bristol-Myers Squibb (BMS) company in the year 2000 as a PhD organic chemist in the small-molecule API process technology department. During that time, he developed scalable syntheses and utilized process analytical technology (PAT) to monitor reactions and crystallizations from the laboratory to the pilot plant. 

Matthias Bucerius, Head of Actives and Formulation, MilliporeSigma, the Life Science Business of Merck KGaA, Darmstadt, Germany

, serves as head of actives and formulation at MilliporeSigma, the US and Canadian life science business of Merck KGaA, Darmstadt, Germany. He joined the company in 2004 after working as a strategy consultant. 

Anil Kane, PhD, Global Head of Technical and Scientific Affairs, Pharma Services, Thermo Fisher Scientific

, has more than 25 years of experience in the science and business of taking molecules through the entire drug development process, spanning early-stage development to scale-up and commercial manufacturing and includes technical transfers between global sites and drug life cycle management.

Stephen Hoag, professor and director of the APhL, Dept. of Pharmaceutical Sciences, University of Maryland School of Pharmacy

, oversees project management, provides scientific oversight of projects, and handles client relations. In addition to his academic experience, he has worked for the World Health Organization, 3M Pharmaceuticals, and Abbott Laboratories. 

Ilan Avni, VP BD, marketing, and IP, Wavelength Pharmaceuticals

, has more than 20 years of experience in the global pharma, API, and medical devices industries. Avni has been with Wavelength Pharmaceuticals since 2006 and served in various business development, pipeline, and portfolio management roles. 

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.

: Biopharmaceutical drug development and manufacturing

Automating pharma and biopharma processes

Videos

In this episode of Drug Digest, Chris Spivey, editorial director, and Meg Rivers, senior editor, dive into APIs, excipients, and formulation advances, specifically pairing the right APIs and excipients for optimizing formulations.

Drug Digest: Pairing the Right APIs and Excipients for Optimizing Formulations

As COVID-19 swept across the world, it has impacted millions of individuals and families. During that time, the biopharmaceutical industry came together to create treatments as swiftly as possible. As of January 2022, the main types of COVID-19 vaccines to treat SARS-CoV-2 that are approved or authorized include (1):

Messenger RNA (mRNA) vaccines, which use genetically engineered mRNA to teach cells how to make a protein that triggers an immune response (e.g., Pfizer-BioNTech and Moderna’s COVID-19 vaccines).

Viral vector vaccines give cells genetic instructions to produce antigens, using a different, harmless virus from the one the vaccine is targeting (e.g., Johnson & Johnson’s [J&J] COVID-19 vaccine).

Telma Lery, Janssen EMEA therapeutic area lead for infectious diseases and vaccines at Johnson & Johnson, explains that the company’s COVID-19 vaccine candidate (also known as Ad26.COV2.S, Ad26COVS1, VAC31518, JNJ-78436735, or Ad26-S.PP) is a monovalent, recombinant, inactivated/non-infective adenovirus vector (similar to a cold virus), which contains a transgene that codes for the coronavirus spike (S) protein.

Other vaccines are in the works as well. Some of the COVID-19 vaccines in clinical trials include—but are not limited to—whole virus, protein subunit, and nucleic acid vaccines (RNA and DNA) as well as more mRNA and viral vector vaccines (2). Vaxart, an American biotechnology company, is developing oral recombinant vaccines, one of which is in clinical trials in the United States as a candidate to prevent COVID-19.

“‘Recombinant vaccine’ means using DNA technology to make a protein target (i.e., antigen), rather than using the native virus to make the antigen,” says Sean Tucker, chief scientific officer of Vaxart. “Most flu vaccines [are] made in eggs by growing a flu virus, deactivating it, and injecting it in a vaccine. We use a dead common cold virus to deliver the DNA encoding the antigen to the person, where the antigen is then made. Our vaccine delivers the DNA via a tablet that breaks open in the intestine. Our vaccine works because we have a molecule that tells the immune system to pay attention to the antigen that is being made.”

“Most recombinant vaccines are made in a liquid that is injected into the arm, like the Hepatitis B vaccine. Our vaccine is dried and tableted with inert ingredients; so, it can be swallowed,” Tucker explains.

J&J has worked with industry partners, governments, and health authorities since the beginning of the COVID-19 pandemic to develop a preventative COVID-19 vaccine candidate, Lery explains. But prior to the pandemic, the company researched vaccine technology, which Lery believes granted J&J a head start in the development of its COVID-19 vaccine. The vaccine technology, AdVac, is based on the development and production of adenovirus vectors (gene carriers).

“There are 57 identified distinct variations (serotypes) of adenovirus, a type of virus that causes the common cold. Adenovirus vectors (gene carriers) are genetically altered forms of an adenovirus and lack the DNA needed to replicate. So, the vaccine cannot cause a cold, and the protein it produces cannot cause harm either,” says Lery, adding that the vaccine technology makes use of adenovirus vector Ad26, specifically.

One of the differentiating factors in the development of J&J’s COVID-19 vaccine is what could be termed “multitasking efforts.” The company combined phases of early-stage trials and had its discovery and manufacturing teams conduct processes in parallel—rather than sequentially.

The process for developing an oral recombinant vaccine, on the other hand, is similar to an injectable vaccine in terms of the clinical trials and the path to approval, according to Tucker.

“We began by identifying six vaccine candidates and winnowed the list to two,” Tucker continues. “Our initial Phase I trial tested a version that made two different antigens from SARS-CoV-2, the S protein and the nucleocapsid (N) protein. That S+N candidate made very strong T cell responses and nasal antibody responses that were cross-reactive against a wide variety of coronaviruses. The current set of trials (Phase II in the US) is evaluating an S-only protein approach, which made better antibody responses in non-human primates.”

But the process of identifying and progressing to clinical trials in a pandemic wasn’t without its challenges. In early 2021, Vaxart had to compete with other biotech companies for manufacturing space. Fortunately, the company had two plants for producing pills for their clinical trials and had enough materials on hand.

Some of the main differences between a COVID-19 oral tablet vaccine from injectable COVID-19 vaccines, according to Tucker, include:

Immune responses are triggered in the mucosa and the serum with a COVID-19 oral tablet vaccine (based on preclinical and clinical testing), unlike the existing vaccines that are serum-only.

Ease of distribution and vaccination with a COVID-19 oral tablet vaccine, which eliminates the need for special accommodations to transport injectable vaccines that require cold chain infrastructure as well as the need for trained professionals to administer vaccines.

The research behind COVID-19 vaccines: antigens

Understandably, the COVID-19 vaccines weren’t created without upfront heavy lifting. One company, The Native Antigen Company, part of LGC Clinical Diagnostics, provides commercially available S1 and S2 antigens for SARS-CoV-2, which include the amino mutations associated with different variants. The company developed more than 100 antigens, antibodies, receptors, and kits for the coronavirus, which have been used by diagnostic, therapeutic, vaccine, and public health organizations to study SARS-CoV-2 and develop countermeasures against it.

Vaccine developers can use S mutant antigens to raise mutant-specific antibodies and develop assays (often enzyme-linked immunosorbent assays) to assess the efficacy of their vaccines, according to James Shore, technical product manager of The Native Antigen Company. In addition, biopharmaceutical companies use The Native Antigen Company’s reagents to develop monoclonal antibody therapies against SARS-CoV-2 and its variants. But how can S antigens be adapted to address the various variants?

“If a variant includes only a couple of point mutations, then a modification of PCR [polymerase chain reaction] amplification can be used to introduce changes to the gene sequence,” says Shore. “More commonly, however, the sequence is computationally redesigned and chemically re-synthesized.”

No matter the type, COVID-19 vaccines and treatments must address new variants and mutations of the virus in some capacity. Some of the variants include Delta, Mu, and Omicron.

“COVID-19 variants arise through mutations in the virus. Mutations may result in the virus obtaining increase in transmissibility, more severe disease, reduction in vaccine or treatment efficacy, etc.,” says Kristina Hsieh, scientific affairs lead, Clear Labs. “There are numerous real-world studies that have shown that getting vaccinated reduces one’s risk of severe illness, hospitalization, and death from the different variants. One of the articles recently published by Bajema 

 indicated a reduction in hospitalization due to vaccination from data gathered from five Veterans Affairs Medical Centers” (3–5).

Hsieh adds that the main difference, genetically, between the variants are different mutations that have accumulated throughout the virus. As the Delta variant has demonstrated, some mutations may lead to increased transmissibility and/or more serious illness. In addition, one of the new variants, Omicron, has been detected in the US.

“The CDC and its public health partners are working closely to monitor this variant,” says Hsieh. “Through Whole Genome Sequencing (WGS), public health laboratories are able to quickly identify, track, and monitor the variant.”

In addition to monitoring variants of the virus and being vigilant in the research and development of new COVID-19 vaccines and treatments, the industry needs to continue to communicate and share resources. Consistent communication and collaboration between all organizations in the biopharmaceutical industry—from governments, to agencies, to developers, to manufacturers, and everyone in between—will play a huge role in combatting the spread and impact of COVID-19.

Gavi, “There are Four Types of COVID-19 Vaccines: Here’s How They Work,” 

M. W. Tenforde et al., “Association Between mRNA Vaccination and COVID-19 Hospitalization and Disease Severity,” 

H. Chung et al., “Effectiveness of BNT162b2 and mRNA-1273 Covid-19 Vaccines Against Symptomatic SARS-CoV-2 Infection and Severe Covid-19 Outcomes in Ontario, Canada: Test Negative Design Study,” 

K. L. Bajema et al., Morbidity and Mortality Weekly Report, 

Effectiveness of COVID-19 mRNA Vaccines Against COVID-19–Associated Hospitalization — Five Veterans Affairs Medical Centers, United States, February 1–August 6, 2021


Volume 46, Number 2
February 2022
Pages: 26–28

When referring to this article, please cite it as M. Rivers, "What’s Next for COVID-19 Vaccines and Variants?", 

Articles

Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants. 

What’s Next for COVID-19 Vaccines and Variants?

Enacted by Congress on Nov. 27, 2013, the US Drug Supply Chain Security Act (DSCSA) is intended to build a more secure supply chain in the United States with the ability to identify and trace drug products and limit exposure to counterfeit, contaminated, and otherwise harmful drugs. Everyone in the pharmaceutical supply chain has had to pivot to meet the DSCSA requirements, including manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Manufacturers, specifically, have had to incorporate serialization into their manufacturing and packaging lines and will need to consider aggregation implementation as well if they haven’t already.

“At Catalent, we started planning and implementing serialization over five years ago,” says Rebecca Mullis, Engineering Project Manager, Catalent Biologics. “But Catalent, being a contract development and manufacturing organization [CDMO], wanted to be ahead of the curve and ahead of our competitors to have serialization available for our customers. In doing so, we evaluated multiple vendors and evaluated different types of equipment.”

According to Mullis, Catalent selected vendors, purchased equipment, and integrated software and data management platforms. In the process, they moved from a manual process to a more automated one. For line-level equipment, Catalent chose to work with Mettler Toledo, which included an automated print and inspection station. For a cloud provider, they chose to work with TraceLink.

Setting up serialization and aggregation from day one

For some manufacturers, from day one, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation. Catalent, for example, didn’t wait for the 2023 aggregation deadline. Instead, the company worked toward full compliance from the beginning, integrating both serialization and aggregation into their manufacturing process immediately.

“When the operators go to pack the cases, there's another piece of equipment with the overhead camera, and it takes a snapshot of every layer in the case and captures every serial number of every carton. Once that's done, it goes to the database and prints a label. We manually apply the label to the case, put the case on the pallet,” says Mullis. “At this point, the operator will take a hand scanner and scan the serial number of every case going onto that pallet. Once the pallet is full, we’ll print a separate label. That label is applied to the pallet, and it's all tied to the batch … Again, all the serial numbers are going into this database that resides on the server side. When we go to ship the product, we already have the process. This is from day one that we implemented this.”

After this, the product is shipped and all serialized data are stored in cloud-based storage, which is provided by TraceLink. It's also how Catalent sends the data back to the client.

Like Catalent, Thermo Fisher Scientific also included aggregation in their initial serialization design even though it wasn't required in the initial phase of serialization. For Thermo Fisher, once they selected their equipment and software vendors, they moved straight to validation.

“Learning the systems now and the processes and how they all tie together, that was key to developing the qualification protocols, SOPs [standard operating procedures], and then training of all those individuals from packaging to IT and QA [quality assurance] as well,” says David Bond, senior manager and serialization program lead, Thermo Fisher. “Overall, coaching of employees from all levels in the organization on a new process just so everyone was aware of what was going on and what needed to be done for serialization.”

Since Thermo Fisher’s initial implementation, Bond states there have been ongoing process improvements to keep up with the evolving landscape for serialization. From a training perspective, specifically, there was much to learn and standardize. Bond recalls how the company developed training plans for different levels and different users of the serialization system—from QA to operations.

“On the operations floor, taking samples became a different process for them, managing the serial numbers, managing the overall process for serialization. It was something new initially,” says Bond. “To be honest with you, a lot of packaging operators were really afraid of serialization. Just working with them and giving them that comfort level. Before you know, they were making suggestions.”

Meanwhile, for manufacturers with a global footprint, such as Recipharm, serialization and aggregation involved creating a global program. Across 15 sites, Recipharm acquired equipment, hardware, and software and established a global program that took approximately three years to implement at all the sites, according to Staffan Widengren, Director Corporate Projects, Recipharm.

Similar to Catalent and Thermo Fisher, Recipharm selected vendors for serialization. For equipment, the company chose Marchesini; for software and hardware, they chose SEA Vision; and for data reporting, they chose TraceLink. Widengren estimates the process of ordering the equipment to having the equipment installed and qualified on the site took around 10 months from when it was started to when everything was connected. However, it’s important to note that aggregation is not a requirement in Europe as it will be in the US as of 2023.

“First, it was the machine, which we took from Marchesini, and then we prepared all the documents required for that. Then we ordered the machine together with the software. The software came from SEA Vision, and it was the responsibility of Marchesini to see that the machine and the software were integrated,” says Widengren. “The next step after the order—it took around six months from when the order was placed and when the machine was ready for what we call the factor acceptance test (FAT). So, we went down to the supplier for the FAT and when that was successful, we got approved to ship the machine to the site. And that was another two to three months, depending on when the site needed or could install it. Then we do what we call the ‘site acceptance test.’ Then the machine was ready for you to use for serialization packs. The last thing was to connect it with TraceLink and the customers in TraceLink.”

Widengren adds that, as a CDMO, Recipharm isn’t allowed to connect to the European Hub. Only the market authorization holder can do that. Therefore, Recipharm reports the serialization data to their customers, and then their customers report it to the EU-hub.

For Catalent, Thermo Fisher, and Recipharm, it seems that serialization—and aggregation—efforts are well underway. But that doesn’t mean there haven’t been a few unexpected hiccups along the way.

The biggest challenge Catalent, specifically, has had relates to data storage. According to Mullis, because the company has been expanding, the database that houses serialized data is filling up more quickly than expected. Therefore, their current challenge is finding a way to archive the data while still maintaining data integrity and meeting requirements.

“With data management, this became a big target for our data integrity team,” says Bond. “There was an enormous volume of new data that had to be retained for specific regulations—storage backup, security all had to be considered. And of course, keeping Part 11 [21 

 Part 11] compliance in mind along with the data. Reviewing audit trails as a part of that. Data review became a key factor in managing overall data for serialization.”

Manufacturers are the first step in the serialization process. As such, they must be the first ones to have serialization—and aggregation—in place for the essential data to be accessed by downstream partners. Hopefully, there will be no further delays due to the COVID-19 pandemic and smooth sailing ahead for global serialization efforts.


Volume 46, Number 2
February 2022
Pages: 34–35

When referring to this article, please cite it as M. Rivers, “Serialization and Aggregation from a Manufacturing Perspective," 

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

Serialization and Aggregation from a Manufacturing Perspective

In the modern bio/pharmaceutical industry, countless services are outsourced, including manufacturing, process development, scale-up, regulatory compliance assistance, analytical services, software and cloud services, and much more. But what should companies looking to outsource know prior to selecting vendors and partners? In addition, what should the companies that are outsourcing services be aware of?

interviewed David Heiger, associate VP, Agilent CrossLab Group; Nandu Deorkar, vice president of R&D production, Avantor; Sébastien Ribault, vice president and head of end-to-end solutions, Life Science business of Merck KGaA, Darmstadt, Germany; Angelo Filosa, PhD, portfolio director, professional and technology services OneSource, PerkinElmer; and Christoph Zehe, research fellow, advanced cell biology, Sartorius Corporate Research, on what outsourcing partners wish you knew.

What companies offering outsourcing services should know

: What are your top recommendations for companies offering outsourcing services?

Clearly define what you want to outsource and why

. Classify activities as core to your work and non-core and then identify partners that have expertise in the non-core activities that are a strategic aspect to how you run your business so your internal team can focus on the science you are advancing.

. Once you have identified the non-core activities, then you need to decide whether they are outsourced or insourced and what needs to be supported on-site or can be done remotely. Certain activities are non-core but still must be done onsite for various reasons. This process is part of defining your outsourcing strategy and identifying the correct partners.

. Make sure to properly evaluate vendors and understand their expertise and how they can grow with you as you evolve your outsourcing strategy. You might look at one service today, but [you will] likely expand the scope in the future; so, it’s important that the provider can grow with you.

Ribault (Life Science business of Merck KGaA, Darmstadt, Germany)

Determine the end goal and assess the team

. It is important for companies looking to outsource to define their end goal and determine their key experts and resources to reach that goal.

. By defining a step-by-step strategy early in the development process in alignment with quality and regulatory requirements, companies looking to outsource can foresee potential risks and challenges before they arise and help determine the best course of action to help mitigate these risks.

If what you require is absolutely core to your business, be cautious about outsourcing. But don’t build what you can buy. It’s important to distinguish between the ‘core’ and the ‘context’ from the outset. If something is core to your business, then it might be more cost-effective, efficient, and reliable to think about sourcing this yourself. Part of deciding whether to outsource will be influenced by your timeframe—are you looking for a short-, medium-, or long-term solution? This way you can determine whether it’s worth making a large investment up front to handle the operation in-house. If it’s something that is readily available and other suppliers have years of skill in that area, then outsourcing is the right option.

Think through your business objectives to ensure you are selecting an appropriate partner or vendor for the long term

. Take the time to remind yourself of what you are trying to achieve in the first place and how these relate to your core business objectives. Having transparent conversations to ensure your vendor understands your objectives can give you a good head start. The last thing you want is to be tied into a contract if it’s wrong for your core business objectives. These objectives can be aligned with a broader vision for your business and brand. For example, you may want to partner with a vendor with similar commitments to sustainability to make your business greener. If you are committed to offering your customers highly innovative solutions, you’ll need to ensure your vendor is continuing to invest in the latest technologies the market has to offer.

Companies need to look beyond just unit cost

. To provide total value, a service provider’s capabilities should be understood. Like choosing a contractor, companies shouldn’t make a decision based on the cost alone. They need to make sure that the service provider can meet their needs to complete the project.

Expectations should be clearly communicated to the service providers as early as possible

. The project requirements change over the progression of the project. Open dialogue with your service provider on any changes sooner than later would help to overcome potential delays.

Choose a provider with proven performance and expertise 

… The capabilities and experience should be proven by a track record, which gives insight into the number of successful projects, experiences with different product types (antibodies, complex molecules, etc.), and regulatory acceptance (projects that have reached clinical phases, market approval, etc.).

Choose a provider offering a comprehensive service and product portfolio

. It is important to keep the whole drug development process in view. A good partner should not only offer individual isolated services but provide more holistic support … Such complete solutions ensure higher success rates, shorter timelines, and simplified project management and communication.

: What are your top recommendations for companies seeking outsourcing partners?

. Stay close to your core competencies and ensure a best-in-case experience for your clients.

Consider reviewing where your team is spread too thin and not able to support what is key to your business

. Look at outsourcing as a way of taking care of operations. This is important because business can be a stressful, high-paced environment, and handing over operations to a service provider can really help to focus the team.

. The customer’s molecule is often ‘the life of their company’; so, they place a significant amount of trust when handing it off to a contract development and manufacturing organization (CDMO). They want more transparency in their molecule’s complex development and manufacturing process. A key element in creating transparency is communication, and excellent partners should also be excellent communicators. This includes access to its experts when urgent matters come up, as they will.

. A key element in the outsourcing relationship is relying on your partner to possess distinct scientific insight and expertise for your molecule’s unique journey.

. A good partner should be flexible to help meet their customer’s needs so that they are successful in achieving their milestones. Having the right capabilities, capacity, and scale to meet the client wherever they are in their molecule’s journey, when and where it is needed, is critical. It sounds pretty straightforward, but many CDMOs today don’t have enough capacity or capabilities to meet their customers’ timelines.

. Outsourcing companies need to spend more time listening to their customers rather than trying to make sales pitches. It’s critical to understand customers’ process/product requirements and application needs to deliver the service that would exceed customers’ expectations.

Capabilities and limitations should be laid out early in the project discussion

. This would help avoid any promises that cannot be delivered.

. Companies should work with customers on a project timeline that can be delivered upon. Since outsourcing buffer management is a part of complex biopharma processes, it is essential that all outsourced services meet the customers’ critical timeline. If the project timeline cannot be met, always communicate early to find alternative solutions or paths.

. In addition to good technologies, service providers also require a high level of flexibility and customer focus to overcome the manifold challenges related to biologics development. This includes tailor-made development approaches, short lead and response times, the possibility to stop or change work packages (also on short notice), clear and efficient communication (ideally single point of contact), and flexible business models.

Establish and apply platform technologies

. Well-developed and efficient technologies are the basis to provide cost-effective services and fulfill the steadily increasing demands with respect to timelines, yields, scalability, and product quality. Furthermore, good platforms ensure regulatory compliance and a high project success rate.

. Single-vendor/one-stop-shop approaches comprising the full spectrum of cell-line development, cell-culture media, cell banking, analytical, and biosafety testing services provide big advantages, such as higher success rates, shorter timelines, and simplified project management and communication.

. Understand exactly what your client’s needs are so that you can meet them in the smartest ways.

Find solutions for multiple critical needs

. Once needs are identified, create a solution that solves multiple critical needs (vs. only one or stove-piped issues). Creating an improved overall workflow will benefit both sides of the collaboration.

. Good outsourcing is about creating optimal solutions and long-term, trusted relationships. Part of this can mean saying no sometimes and being flexible in creating new directions together. This really looks out for a client’s best interests. The partnership becomes stronger when you create opportunities for acceleration and improvement of the workflow.

When referring to this article, please cite it as M. Rivers, “What Outsourcing Partners Wish You Knew," 

Industry experts share their top outsourcing tips from both the perspective of companies offering outsourcing services as well as for companies looking to outsource.

What Outsourcing Partners Wish You Knew

 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.

In this episode, Chris Spivey, Editorial Director, and Meg Rivers, Senior Editor, interview industry experts to discuss 2022 trends along with a few trends that emerged in 2021, specifically:

The demand for US-based suppliers in 2022

Ensuring resources in the supply chain, including collaborations with competitors

Sustainability in APIs; API and drug product interface; API and excipient trends

Yvonne Duckworth, Automation Engineer, CRB

Cary Martin, VP of Marketing, August Bioservices

Gabe Longoria, Chief Commercial Officer, Astrea Bioseparations

Merrilee Whitney, Head of Biocontinuum Platform, MilliporeSigma (the Life Science business of Merck KGaA, Darmstadt, Germany)

Helen Anderson, Commercial Lead, USA, Aspen

San Kiang, CTO, Porton Pharmatech/J-Star Research

Anil Kane, Global Head of Technical Scientific Affairs, Pharma Services, Thermo Fisher Scientific

Matthias Bucerius, Head of Actives and Formulation, MilliporeSigma (the Life Science business of Merck KGaA, Darmstadt, Germany)

Jeff Woodhead, Senior Scientist, Simulations Plus

Gregory Lane, PhD, Senior Research Investigator, Bristol Myers Squibb

Podcasts

In this episode of the Drug Solutions podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview experts on up-and-coming 2022 trends in the bio/pharma industry.

Drug Solutions Podcast: 2022 Bio/pharma Trends: US-Based Suppliers, Digitization, and Sustainability

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part four, 

serialization from a regulatory perspective

Watch part 1: serialization from a manufacturing perspective

Watch part 2: serialization from a packaging perspective 

Watch part 3: serialization from a software perspective

With the aggregation considerations for the US Drug Supply Chain Security Act (DSCSA) on the horizon and uncertainties about authentication of medicines in a post-Brexit Europe, questions about compliance—and the security of the drug supply—are at the forefront.

In this discussion, global supply chain experts examine implications of the DSCSA (specifically serialization and aggregation) and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD). 

As the aggregation considerations for the DSCSA approaches, what do companies across the bio/pharmaceutical supply chain need to tackle now, and what can they expect going forward? 

Within Europe, compliance with the delegated EU FMD regulation has been required since 2019. However, implementation of the delegated regulation has not been smooth sailing. In what position has Brexit left stakeholders with regards to medicines authentication? Has it been/might it be necessary to further update manufacturing and packaging lines to accommodate variances in regulations?

Experts from across the global supply chain will provide insight and answers to these questions.

 is the vice president of community engagement at GS1 US. GS1 is a not-for-profit organization that develops and maintains global standards for business communication. Angela is responsible for driving broader adoption of GS1 Standards to help industries achieve their goals for improved traceability, information transparency, and data quality.

 leads the GS1 Healthcare Global Public Policy Work Team, which has the mission to interact with decision-makers globally and to provide strategic leadership on the use of GS1 standards in the healthcare sector.

Watch other videos in this keynote series

Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.