X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Catalent and Zumutor Biologics Collaborate to Manufacture First-in-Class mAb to Treat Solid Tumors

    Inexperience Makes CDMOs Struggle With Cell And Gene Therapy

    FDA Releases Draft Guidance On Digital Health Technologies

    Researchers Utilize AI To Combat Drug-Resistant Bacterium

    Targeting Tumor-Positive Lymph Nodes Boosts Cancer Treatment

    Ovarian Cancer Type Gets An Effective Targeted Drug Combo

    New Singapore Therapy For Antibiotic Resistant Lung Issues

    Diosynvax – A Needle-Free Revolution In COVID-19 Vaccination

    Genome Analysis Offers New Hope For Severe Skin Condition

    Vorasidenib – A Potential Game-Changer In Glioma Treatment

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Catalent and Zumutor Biologics Collaborate to Manufacture First-in-Class mAb to Treat Solid Tumors

    Inexperience Makes CDMOs Struggle With Cell And Gene Therapy

    FDA Releases Draft Guidance On Digital Health Technologies

    Researchers Utilize AI To Combat Drug-Resistant Bacterium

    Targeting Tumor-Positive Lymph Nodes Boosts Cancer Treatment

    Ovarian Cancer Type Gets An Effective Targeted Drug Combo

    New Singapore Therapy For Antibiotic Resistant Lung Issues

    Diosynvax – A Needle-Free Revolution In COVID-19 Vaccination

    Genome Analysis Offers New Hope For Severe Skin Condition

    Vorasidenib – A Potential Game-Changer In Glioma Treatment

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development

Inexperience Makes CDMOs Struggle With Cell And Gene Therapy

Content Team by Content Team
12th June 2023
in Drug Development, News
Catalent and Zumutor Biologics Collaborate to Manufacture First-in-Class mAb to Treat Solid Tumors

CDMOs (contract development and manufacturing organizations) are facing challenges due to the increasing number of companies preparing to scale up their cell and gene therapy manufacturing for Phase III trials and commercialization. While physical capacity has been blamed, the real issue lies in the lack of experience.

Manufacturing novel products requires process innovation, but advanced therapies pose unprecedented challenges compared to the early days of monoclonal antibodies in the biopharmaceutical industry. Despite rapid growth, standardization remains distant. SMEs must partner with CDMOs to quickly scale by utilizing manufacturing capabilities and knowledge.

Despite new manufacturing players and investments in capital expansions, SMEs are unhappy with their CDMOs due to the lack of experienced personnel. The high demand has led even industry leaders to depend on inexperienced staff, causing issues. Training new staff for cell and gene therapy manufacturing takes a significant amount of time, and high turnover worsens the situation, particularly in biotech hubs where job switching is common. Insufficient training results in avoidable errors and basic mistakes.

Inexperience is not only a concern on the clean room floor but also in the guidance provided by CDMOs to developers. New companies in the field rely on their CDMO partners for guidance, but a common issue is that inexperienced SMEs underestimate the time needed for scaling up, leading to overwhelming situations. Moving too quickly without proper preparation is detrimental, making experienced CDMOs valuable in setting the right pace and ensuring thorough process development prior to clinical trial scaling.

Since the industry is relatively young, SMEs seek partners with specific expertise in areas such as preferred vectors or cell types. While the developer may contribute certain assays or novel aspects of the manufacturing process, they acknowledge that they don’t have all the necessary pieces. Thus, they aim for a balanced approach between outsourcing and insourcing manufacturing. However, recent industry turbulence has led to smaller specialized companies being acquired by larger ones, which can result in clients being deprioritized.

The right partner is crucial for successfully delivering new medicines to patients, while the wrong partner can cause numerous problems. CDMOs’ reputations precede them in the insular industry. A single mistake can be disastrous for small companies, while larger ones may have better safeguards. Successful CDMOs prioritize maintaining relationships by promptly addressing issues openly.

SMEs often struggle to receive the same level of attention from service providers as larger players do. Therefore, it is crucial to collaborate with a CDMO that values its business. A CDMO’s commitment to a product is evident through early engagement in developing a chemistry, manufacturing, and controls (CMC) strategy and a strong emphasis on process development. These capabilities are essential, but many CDMOs merely pay lip service to development while focusing on profitable pivotal clinical trial manufacturing. Companies going through the CMC process for the first time without an established path forward can face challenges.

Conversely, an experienced CDMO demonstrates their understanding and execution of the pathway forward. Developers can assess this by the questions asked and the CDMO’s comprehensive experience across the entire manufacturing process. A strong multidisciplinary team ensures adherence to regulatory quality standards without mistakes. Half the capabilities are not enough for a successful partnership.

Considering a CDMO’s location is important when evaluating its staff. Busy hubs often experience intense competition for talent, resulting in overpromotion and title inflation in rapidly growing sectors like advanced therapies. However, CDMOs located near reputable universities and with access to public apprenticeship programs indicate a stable talent pool. Given the scarcity of talent, it is worth considering a partner’s company culture. In cell therapy manufacturing, strong teams are composed of experienced leaders and implement effective recruitment and mentorship programs to cultivate emerging talent.

Part of industry growth comes from SMEs choosing to build or buy their own manufacturing capabilities due to a lack of trust in partnerships. However, this solution harms the entire industry. CDMOs need to improve their expertise and transparently describe their capabilities. SMEs should evaluate potential CDMO partners based on reputation, experience, and understanding of their needs. It’s important to find a CDMO with the right culture for success.

Previous Post

$85bn M&A Splurge Helps In Big Pharma Dealmaking Recovery

Related Posts

Pathways Laid Down By The CMS For Drug Price Negotiations
Facilities & Operation

$85bn M&A Splurge Helps In Big Pharma Dealmaking Recovery

12th June 2023
Clinical Trials

FDA Releases Draft Guidance On Digital Health Technologies

9th June 2023
News

Researchers Utilize AI To Combat Drug-Resistant Bacterium

8th June 2023
News

Targeting Tumor-Positive Lymph Nodes Boosts Cancer Treatment

8th June 2023
Manufacturing

AMR Certification For Responsible Antibiotic Manufacturing

8th June 2023
Drug Development

Ovarian Cancer Type Gets An Effective Targeted Drug Combo

8th June 2023

Latest News

Catalent and Zumutor Biologics Collaborate to Manufacture First-in-Class mAb to Treat Solid Tumors
Drug Development

Inexperience Makes CDMOs Struggle With Cell And Gene Therapy

12th June 2023
Pathways Laid Down By The CMS For Drug Price Negotiations
Facilities & Operation

$85bn M&A Splurge Helps In Big Pharma Dealmaking Recovery

12th June 2023
Clinical Trials

FDA Releases Draft Guidance On Digital Health Technologies

9th June 2023
News

Researchers Utilize AI To Combat Drug-Resistant Bacterium

8th June 2023
News

Targeting Tumor-Positive Lymph Nodes Boosts Cancer Treatment

8th June 2023
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In