Early-Stage Biotech CDMO Partnering Strategies with Wacker Biotech

John Childers, Director of Business Development for Wacker Biotech’s North American operations, emphasises the importance of early CDMO partnerships: “Working with an experienced CDMO partner can really help you stay on track for budget and schedule. Think long term – the investment with an external partner can substantially save you time and money.”

As part of Wacker Chemie, a century-old German chemical company, the biotech division leverages over 20 years of experience in advanced therapy manufacturing for contract development and manufacturing.

Speaking to the PharmaSource podcast ahead of CDMO Live 2025, John shares best practices for successful partnerships and explains how Wacker Biotech is positioning itself for growth in the evolving contract manufacturing landscape.

Best Practices for CDMO Partnerships: A Strategic Framework

Early engagement with CDMOs has become increasingly critical, particularly for securing funding, according to John.

“We’ve been hearing from VCs that partnering with a CDMO early and having a secure CMC strategy is really a critical component to secure funding,” he explains. “We’ve even helped in writing submissions and letters of support, along with project planning for funding requests.”

John recommends several key strategies for successful CDMO partnerships from an early stage:

1. Early Phase Integration

• Connect during IND Phase 1 stage when considering GMP requirements
• Leverage CDMO expertise for regulatory guidance
• Establish clear paths for process scale-up
• Ensure processes are GMP-compatible from the start

“You want to make sure that your process is GMP-able,” John emphasizes. “Many early academic processes are just not amenable for GMP upscaling, and clients could really benefit from understanding this as early as possible.”

2. Due Diligence and Realistic Planning 

John advises companies to:

• Carefully evaluate CDMO capabilities and track record
• Be wary of unrealistic timelines or cost projections
• Consider the CDMO’s financial stability and longevity
• Look for proven experience in similar therapeutic areas

“Be skeptical of overly aggressive promises around costs and timelines,” he cautions. “You really need to be able to set realistic expectations with your partner. And it goes both ways – what you’re expecting from your CDMO partner and what they’re actually capable of delivering.”

3. Communication and Access Protocols 

Successful partnerships require:

• Regular meetings with project managers
• Direct access to subject matter experts (SMEs)
• Clear communication channels with:
  • Quality groups
  • Manufacturing teams
  • Process Development teams
  • Site leadership

“Connect and meet regularly with your Project Manager and make sure that you are given full access to the team of SMEs,” John advises. “The site leadership needs to show that they are invested in supporting your project, and you have their full buy-in as well.”

4. Strategic Alignment and Partnership Mindset 

John emphasises the importance of viewing the CDMO relationship as a strategic partnership rather than a simple service provider arrangement:

• Maintain open and transparent communication
• Share long-term development goals
• Align on quality and regulatory expectations
• Build collaborative problem-solving approaches

“For us, we would hope that you would really view us as an extension of your team,” John states. “We all have the same goals here. The goal is to get these treatments to the patients that need them.”

5. Technical Considerations and Process Development 

Key areas to address early in the partnership include:

• Process scalability assessment
• Technology transfer requirements
• Analytical method development
• Raw material strategies
• Manufacturing platform compatibility

“Be honest, open and candid with your partners,” John advises.

Wacker Biotech’s resilience and strategic growth

Despite industry-wide challenges in 2024, including financial market uncertainty and continued layoffs, Wacker Biotech has experienced positive growth, particularly at its San Diego site. The company has increased headcount and secured new projects, positioning itself as a stable partner in uncertain times.

“Clients are really valuing organisations that offer stability and assurance that we’re going to be here for the long run,” John explains. “We’ve all weathered the storm together, and Wacker has been around for quite some time – we’re not going anywhere.”

The company maintains a strong focus on research and development, with recent investments including:

– Opening an mRNA Center of Excellence in Germany

– Double-digit million Euro investments in R&D including a new biotechnology research center opening in Munich in 2025

– Development of new viral vector technologies

– Process efficiency improvements to reduce costs

“We have 10 active suites available for production globally,” John notes. “Being able to operate globally really gives us open, flexible capacity for continued growth.”

“Within our E. coli team and our ESETEC® cell line, we’ve been able to reduce the COGS by about 3x and reduce wholesale impurities by about 1,000x,” John shares. “With our FOLDTEC® technology, we’re getting a 5x increase in yield and a 4x reduction in working volume.”

The WACKER group has implemented a comprehensive sustainability program called “SustainaBalance®,” with ambitious targets including a 50% reduction in greenhouse gas emissions by 2030 and net zero by 2045. In 2024, WACKER earned the Gold Level EcoVadis Sustainability Rating.

Connect with the Wacker Biotech team at CDMO Live 2025