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Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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In a press release on Jan. 7, 2025, Phillips Medisize’s parent company, Molex, announced the completion of Phillips Medisize’s acquisition of Vectura Group from Vectura Fertin Pharma, of Chippenham, United Kingdom, a subsidiary of Philip Morris International (1). Phillips Medisize, a global contract development and manufacturing organization which designs and makes products for the pharmaceutical drug delivery, 

 diagnostic, and medtech markets, now adds Vectura’s inhalation capabilities to its stable of services.

The announcement closes a transaction which had previously been disclosed by the two sides involved in September 2024 (2). At that time, the parties expected the deal to close by the end of 2024, meaning official confirmation comes just a week past that deadline.

“The Vectura team is delighted with the completion of the acquisition,” said Geraldine Venthoye, PhD, the chief scientific officer of Vectura Fertin Pharma who has now been appointed to the same post, as well as vice president, for the Phillips Medisize Medical business (1). “We are excited about the opportunities and scale of Phillips Medisize, which will allow us to deliver our formulation and combination product expertise to more pharmaceutical customers as part of end-to-end pharmaceutical development.”

“The acquisition of Vectura reflects our commitment to advancing industry-leading medical capabilities for our customers,” said Molex CEO Joe Nelligan in the January 7 press release (1). “Together Phillips Medisize and Vectura will unlock significant growth potential to support the growing need for inhalation therapies.”

Phillips Medisize itself had previously been acquired by Molex, whose headquarters are in Lisle, Ill., in 2016 (1). The company said in the press release that adding Vectura’s services would enhance its capacity for pharmaceutical R&D.

Vectura’s proprietary technology, plus its experience in the field of combination product development, come to Phillips Medisize in the transaction; this includes dry powder inhalers, metered dose inhalers, nasal inhalers, and nebulizers, according to the press release (1). Among Vectura’s other offerings are pharmaceutical analysis, process development, technical transfer, clinical trial supplies, and regulatory services.

“Phillips Medisize will continue to expand the services we offer pharmaceutical companies thanks to the acquisition of Vectura, particularly in inhalation, to help meet growing patient needs,” said Paul Chaffin, president of Phillips Medisize. “Together Phillips Medisize and Vectura are uniquely positioned to collaborate with leading pharmaceutical customers to develop innovative products that address the growing global demand for new therapies to treat chronic respiratory diseases like asthma and COPD [chronic obstructive pulmonary disease], as well as non-respiratory conditions.”

With a workforce of already more than 6000 covering 30 job sites in North America, Europe, and Asia, Phillips Medisize will add approximately 350 employees with the acquisition of Vectura (1). Among those are some 1200 engineers and scientists.

1. Phillips Medisize. Phillips Medisize Expands Its Inhalation Drug Delivery Capabilities. Press Release. Jan. 7, 2025.
2. Phillips Medisize. Molex, A Parent to Phillips Medisize, Announces Agreement to Acquire the Vectura Group Limited, Expanding Its Drug Delivery Capabilities in Inhalation. Press Release. Sept. 17, 2024.

Articles

The transaction, which was first announced in September 2024, expands Phillips Medisize’s inhalation drug delivery capabilities.

Molex, Phillips Medisize Close Acquisition of Vectura Group

Feliza Mirasol is the science editor for 

Denmark-based biotech startup Orbis Medicines recently won major funding to support its pursuit of developing oral alternatives to current biologic drugs, which are primarily administered parenterally.

The company announced on Jan. 6, 2025 that it closed a Series A funding round of $94 million (€90 million), which will go toward development of Orbis’ pipeline of next-generation oral macrocycle drugs, which the company has termed “

Cycles”. This latest funding round brings the total amount raised by the company to $121 million (€116 million).

Macrocycles bind to targets with higher affinity and selectivity than small-molecule drugs, but they have been historically challenging to develop as oral drugs. Orbis Medicines’ technology platform, 

Gen, systematically delivers macrocycle candidates—

Cycles—that are optimized for oral bioavailability. It has been this lack of oral bioavailability that has hindered therapeutic development of this class of molecules in the past (1). The 

Gen platform comprises multiple proprietary integrated elements in a “lab in a loop” system. It starts with hit-finding libraries containing 100 billion compounds. Using automated chemistry, the platform can synthesize and analyze up to 100,000 distinct synthetic macrocycles in weeks, which allows the company to discover candidates with the right properties to enable oral dosing and intracellular targeting.

The company’s pipeline is initially focused on 

Cycle candidates aimed against targets validated by blockbuster biologic drugs, which are delivered by injection, a route of administration that is not favorable with patients. The biopharma industry has been bending its efforts toward developing 

 for biologics that bypass the parenteral route, such as oral and inhaled biologic formulations (2). However, because biologics have more structural sensitivities than small-molecule drugs to factors such as pH and temperature, there are limits to their delivery, especially orally, such as degradation in the alimentary tract and an inability to overcome intestinal cell or mucosal barriers and first-pass metabolism (2). These limitations therefore open a path to alternative orally bioavailable drugs, such as 

“The Orbis Medicines team has impressed us with the data supporting 

Gen, which we believe is the world’s leading discovery engine for oral macrocycle drugs. We are thrilled to support not only their journey to the clinic, but also their longer-term vision as a leader in their field,” said Ed Mathers, partner, New Enterprise Associates (NEA), in the press release (1). NEA led the financing.

In addition to NEA as the lead financer, others that participated in the funding round include new investors Eli Lilly and Company, Cormorant, and the Export and Investment Fund of Denmark as well as founding investors Novo Holdings and Forbion. Morten Graugaard has been appointed as CEO of Orbis Medicines after having served nearly three years as executive chair of its board of directors.

“The company is advancing the potential of macrocycles by developing orally available 

Cycles—a format preferred by patients, physicians, and healthcare systems, particularly for chronic diseases,” said Graugaard in the release. “The interest we have received demonstrates the market appetite for 

Cycles as an oral approach to both validated biologic targets and targets undruggable by other modalities. We have a clear strategy for rapid value creation that leverages the unique capabilities of our 

Gen platform and are excited to advance this important new class of drugs for patients.”

Orbis Medicines Raises EUR 90 Million Series A Funding Round to Develop Pipeline of Oral Macrocycles

. Press Release. Jan. 6, 2025.
2. Mirasol, F. 

Exploring Innovative Means for Biologics Delivery

With the new $94 million (€90 million) funding, the company will develop its pipeline of oral macrocycle drugs, nCycles, against validated biologic targets.



With New Funding, Orbis Medicines to Develop Oral Macrocycles as Alternative to Biologic Drugs

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Pharmaceutical Technology chats about continuous processes and regulatory considerations for processing equipment with Christian Dunne from ChargePoint Technology.

Using Continuous Processes and Automation to Remove Contamination Risk

Continuous production has been employed across many industries for some time to improve efficiencies, reproducibility, and quality. For the bio/pharma industry, continuous processes have come a long way, although semi-continuous is still more widely adopted.

“I think, of late, [continuous processing has] come a long way,” asserts Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology. “We're still seeing there aren’t that many full continuous processes out there, but we do see a lot more semi-continuous processing. So that's where you're sort of combining two or maybe three processes together, and that that may be to start with, in terms of stacking them up, allowing the continuous process of material going from one process into another.”

Additionally, with the advent of more robotics, particularly in a cleanroom space, there is scope for companies to remove the operator from certain aspects of the process, which is helping to reduce risk, Dunne confirms. “Placing a robot into the process stream removes the operator, and that's the best thing you can do, from a containment perspective,” he says. “You have less risk for the operator, but you also have a vast improvement on the product quality as well. We do know from a microbiological perspective that generally it's the operator which is the most contaminating source on the process. So, if you can get [the operator] out of there, you've improved both the containment from the operator perspective, and also the product quality as well.”

Automation and reducing potential contamination are common threads throughout the European Union good manufacturing practice (GMP) Annex 1 guidance document, Dunne notes. “It's kind of a theme that's running through the whole of that document, isolating the operators from the process,” he says. “We're seeing lines now that are almost completely autonomous. And I think that [more automation is] going to be something that's going to come in the not-too-distant future.”

Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology.

Christian Dunne is director of Global Corporate Business Development at ChargePoint Technology—a pharmaceutical containment and aseptic processing specialist company. Christian has worked in the bio/pharma industry for 20 years covering oral solid dosage manufacturing through to sterile processing and fill/finish manufacturing.

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The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda's HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] to treat patients with agammaglobulinemia or hypogammaglobulinemia, Takeda announced on Dec. 27, 2024. Agammaglobulinemia and hypogammaglobulinemia are disorders characterized by very low or absent levels of antibodies. Patients suffering from these disorders have an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID) (1,2). This approval makes HYQVIA the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy to be made available as a treatment option for patients in Japan, according to a company press release. HYQVIA is also under review in Japan for additional indications.

The approval is based on data from two pivotal Phase III trials that evaluated the efficacy, safety, tolerability, and pharmacokinetics in Japanese patients with PID. Data from two Phase III clinical trials in patients with PID in North America were also included in the MHLW submission.

“We are delighted that HYQVIA, approved in more than 40 countries worldwide, has now been approved in Japan,” said Naoyoshi Hirota, regional head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit in Japan, in the press release (1). “The subcutaneous IG therapies currently available in Japan for patients with agammaglobulinemia or hypogammaglobulinemia require infusion once every week or every two weeks. We are proud to offer Japanese patients the first and only facilitated subcutaneous treatment option that offers a reduced dosing frequency of every three or four weeks.”

HYQVIA comprises a combination of one vial of IG 10% and one vial of recombinant human hyaluronidase PH20 (rHuPH20); rHuPH20 increases the dispersion and absorption of IG in the subcutaneous tissue. This increased dispersion and absorption allows for larger volumes to be infused at the infusion site, which in turn allows for less frequent dosing compared to other subcutaneous IG products. Meanwhile, this route of administration can avoid the need to access veins for delivering the therapy. Takeda noted in its press release that the ability to infuse a larger infusion volume is expected to increase administration flexibility for patients with agammaglobulinemia or hypogammaglobulinemia by decreasing the dosing frequency to once every three or four weeks, compared to the weekly or bi-weekly dosing schedule with conventional SCIG treatments.

“There is a high unmet need for plasma-derived therapies (PDTs) in patients in Japan, which is anticipated to increase as education and timely diagnosis rates continue to improve,” said Kristina Allikmets, head of R&D for Takeda’s Plasma-Derived Therapies Business Unit, in the release. “The approval of HYQVIA, the first and only facilitated SCIG treatment, is further evidence of Takeda’s commitment to add to the standard of care for patients in Japan. We look forward to continuing to bring new therapeutic options that support and enhance the experience of patients in our home country throughout the next decade.”

The approval follows Takeda’s previous announcement in March 2023 that the company is investing ¥‎100 billion (US$754 million at the time of the announcement; current conversion is US$635 million) into 

building a new manufacturing facility for plasma-derived therapies (PDTs) in Osaka, Japan

1. Takeda. Takeda Announces Approval of HYQVIA 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia. Press Release. Dec. 27, 2024.
2. Pimenta, F. M. C. A.; Palma, S. M. U.; Constantino-Silva, R.N.; Grumach, A.S. Hypogammaglobulinemia: A Diagnosis that Must Not Be Overlooked. 

 (10), e8926. DOI: 10.1590/1414-431X20198926
3. Takeda. Takeda to Invest 100 Billion JPY in a New Manufacturing Facility for Plasma-Derived Therapies in Japan. Press Release. March 23, 2023.

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

Takeda Receives Japanese Regulatory Approval for HYQVIA Subcutaneous Injection for Treating Agammaglobulinemia or Hypogammaglobulinemia

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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

Innovent Biologics (Innovent), a China-based biopharmaceutical company specializing in treatments for oncology, cardiovascular and metabolic, autoimmune, ophthalmology, and other major diseases, announced on Jan. 2, 2025 that it has entered into a collaboration and exclusive license agreement with Roche. The companies will advance the development of IBI3009, Innovent’s novel delta-like ligand 3 (DLL3)-targeted antibody drug conjugate (ADC) candidate. The collaboration is aimed at bringing innovative treatment options to patients with advanced small cell lung cancer (SCLC).

Under the agreement, Roche receives exclusive global rights to develop, manufacture, and commercialize IBI3009; however, the two companies will jointly focus on the early stage development of the candidate. After early stage development, Roche will take over full development. Innovent, in turn, will receive an upfront payment of $80 million and is eligible to receive up to $1 billion in development and commercial milestone payments. Innovent is also eligible to receive tiered royalties on net sales.

“We are delighted to once again enter a strategic collaboration with Roche, a global leader in oncology, to advance our potentially best-in-class DLL3 ADC candidate. By combining Roche's scientific expertise and global development capabilities with our innovative approach, we are taking a significant step forward in our mission—to empower patients worldwide with affordable, high-quality biopharmaceuticals,” said Samuel Zhang, PhD, chief business officer, Innovent, in the press release (1).

DLL3 is an antigen with low expression in normal tissues but is significantly overexpressed in certain cancers, particularly SCLC and other neuroendocrine tumors, making it an attractive target for emerging therapy development (2). IBI3009 has already received investigational new drug (IND) approvals in the United States, China, and Australia and is currently in a Phase I study.

IBI3009 was developed using Innovent’s proprietary novel topoisomerase 1 inhibitor (TOPO1i) platform. It has shown positive anti-tumor activity in multiple tumor-bearing mouse models, particularly chemo-resistant tumor types. The ADC has also demonstrated a favorable safety profile, according to the company press release.

“We are excited to enter this partnership with the Innovent team to further develop this promising investigational treatment for patients with small cell lung cancer. This partnership builds on Roche’s long history of innovation in the area of ADCs, to address the unmet needs of patients with solid tumors with transformational medicines,” said Boris L. Zaïtra, head of Corporate Business Development, Roche, in the release.

Innovent has four new drug applications under regulatory review, and the company’s pipeline includes three assets in Phase III or pivotal clinical trials with 17 more molecules in early clinical stage. Innovent’s global partners include Eli Lilly and Company, Sanofi, Incyte, Adimab, LG Chem, and MD Anderson Cancer Center.

1. Innovent Biologics. Innovent Enters into Exclusive Global License Agreement with Roche for Novel DLL3 Antibody Drug Conjugate. Press Release. Jan. 2, 2025.
2. Rudin, C. M.; Reck, M.; Johnson, M. L.; et al. Emerging Therapies Targeting the Delta-like Ligand 3 (DLL3) in Small Cell Lung Cancer. 

Under the agreement, the companies will advance development of IBI3009, Innovent’s ADC candidate, which has received IND approvals in the US, China, and Australia.

Roche Forms Partnership Worth Potentially More than $1 Billion with Innovent to Develop Novel ADC for SCLC

on Dec. 31, 2024, FDA announced the reopening of the comment period for the 

 notice (FRN), “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, published on July 25, 2024 (89 

 60436) (2). The comment period has been reopened due to high interest from the industry for the FRN. The comment period will remain open until March 3, 2025 (1).

The December 31 notice establishes a public docket under which substantive comments from interested parties can be submitted on evaluating the immunogenicity risk of host cell proteins (HCPs) in follow-on peptide products. FDA is specifically interested in comments that address suitable methods to detect, identify, and control HCPs in commercial lots of recombinant peptide products (including information on achievable residual amounts of HCPs in the drug product) as well as 

 immunogenicity assessment (IVISIA) of host cell proteins in recombinant peptide products.

Comments can be submitted electronically or in writing. If sent electronically, comments, including any attachments, should be submitted to the Federal eRulemaking Portal at 

. Comments and any accompanying attachments will be posted to the docket unchanged, according to FDA. “Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov,” FDA states in the December 31 notice (1).

Comments that contain confidential information not for public consumption should be submitted as a written/paper submission only.

For written/paper submissions, comments should be submitted by mail, hand delivered, or sent by courier to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For comments submitted in writing, FDA will post the comments, as well as any attachments—except for information submitted that is marked and identified as confidential.

FDA also instructs that all submissions received must include the Docket No. FDA-2024-N-2980 for “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Request for Information and Comments.”

Written/paper submissions that are confidential should be submitted in two copies, with one copy including the information marked as confidential. FDA recommends using a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The agency will review this copy, including the claimed confidential information, in its consideration of comments, while the second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.

“Although follow-on recombinant peptide products can rely on FDA’s findings of safety and effectiveness for a listed drug that is a peptide product, differences in recombinant expression systems used during the peptide production could result in quality attribute differences, including in the host cell protein profile, which in turn, could contribute to differences in immunogenicity risk between a follow-on peptide product and the relied upon listed drug,” FDA states in its announcement. Public comments will help the agency develop recommendations for evaluating and mitigating the immunogenicity risk associated with differences in HCP profiles between the follow-on and listed drug.

For more information about the open docket, including what information to include when submitting comments, see the 

Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period

Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Establishment of a Public Docket; Request for Information and Comments

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.

FDA Announces Reopening of Comment Period Regarding HCP Immunogenicity Risk from Follow-on Recombinant Peptides

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.

FDA Publishes Final Guidance on Advanced Manufacturing Technologies

Contract development and manufacturing organizations (

) are invaluable to the pharmaceutical industry, supporting ever-growing demand with efficiency, consistency, and innovation.

 expected to be worth more than $800 billion by 2028, CDMOs—especially those working with complex cell and 

—will be critical to ensuring that these advanced, targeted therapies can reach the most patients possible.

Below are 5 CDMOs who are poised to make the biggest impact on the pharmaceutical industry in 2025:

 now complete, Catalent is set to assume an even more significant role in the development and manufacture of advanced therapies. In 2024, Catalent announced several new development and manufacturing partnerships, including with IsomAB for its first-in-class antibody for peripheral artery disease; and Siren Biotechnology for its adeno-associated virus (AAV) immuno-gene therapies. It also recently expanded its OneBio integrated platform to include antibody and recombinant proteins, cell and gene therapies, and mRNA.

Coining the phrase “IDMO,” Cellares is innovating cell therapy development and manufacturing by offering a fully integrated experience for its customers. Touting process automation and seamless tech transfer to the company’s global network of “smart factories,” several major cell therapy players have partnered with the company to validate Cellares’ Cell Shuttle platform for cell therapy manufacturing, including Caballeta Bio for its CABA-201 candidate for autoimmune disease, and Lyell’s CAR-T cell therapy.

A long-standing CDMO powerhouse, Lonza is continuing to expand its footprint in the space with continued investment into their 

 sites, including a new drug substance and active pharmaceutical ingredient plant and a commercial drug product facility, both in Switzerland, and the addition of a biologics manufacturing site in the US that it acquired from Roche.

A CDMO spinoff of its larger parent company, WuXi Advanced Therapies continues to lead the cell and gene therapy space thanks to tools and technologies that help bring new therapies to market faster. Cell banking tools and scalable AAV production, as well as advanced analytical techniques, speed up the development process and help keep clients in compliance with regulatory standards.

The Seattle-based biologics CDMO is already the manufacturing partner for several FDA-approved advanced therapies, including a CAR-T therapy from Autolus Therapeutics and a gene therapy from Orchard Therapeutics. It’s expanding portfolio of services is designed to bring speed and precision to the space, making it a strong competitor in several burgeoning sectors, including monoclonal antibodies, lentiviral vectors, AAVs, and antibody drug conjugates (ADC).

Of course, there are many other players in the CDMO ecosystem who are rapidly expanding their offerings to keep up with pharma’s demands. Emerging CDMOs, including South Korea’s Lotte Biologics, have our attention with their rapidly expanding focus in the cell and gene therapy, monoclonal antibody, and ADC sectors. We’re also keen on watching how CDMO-adjacent service providers, including Ori Biotech and AiCella, continue to mold their offerings to help bring life-changing therapies to market faster.

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow. Here are the CDMOs and service providers that are poised to make the biggest impact on the pharmaceutical industry. 

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