Tag Archive for: GMP

Micrograph captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland © NIH

Vaccine maker Sumagen Co. Ltd has launched a  cGMP manufacturing partnership with French Naobios SAS for clinical testing of Sumagen’s inactivated HIV vaccine candidate.
 

Richter-Helm´s expanded manufacturing site at Bovenau, Germany  ready to manufacture your product; ©Richter-Helm

Professionalism and quality are always at the forefront along the whole value chain: from gene to product. To pro-actively meet the evolving demand of the market to produce new assets Richter-Helm significantly increased its manufacturing capacities for biopharmaceutical products at its production site in Bovenau, Germany.

Figure 1: Example of a process landscape; © Richter-Helm BioLogics GmbH & Co.KG

The biotech and pharma branch is growing steadily. Many companies have full order books for the next few years and expect growth. This is the basis for new investments in assets and infrastructure. These growing structures often expose vulnerabilities and challenges for the business. Therefore, companies need to increase the stability and efficiency of their processes.

Picture: © Northway Biotech

When businesses receive a proposal from a contract development and manufacturing organisation (CDMO), it’s much like a first date: first impressions matter. The proposal process not only reveals a CDMO’s services but also hints at the potential relationship’s quality. This is gauged mainly through metrics like timing, quality, and price.

CDMO Minaris Regenerative Medicine GmbH is to manufacture the leukocyte infusion therapy N-LIfT for LIFT BioSciences.

Tag Archive for: GMP

PharmaLab2026_ebm-transkript-event-highlight

Named after the chemical element Darmstadtium (Ds110), it combines the 1,302 m² spectrum congress hall for exhibition stands with 3,700 m² of light-flooded foyer space, giving exhibitors an ideal setting to connect with PharmaLab Congress delegates and exhibition visitors.

In 2026, a new topic will be addressed in a dedicated track:

– Data Quality Management of Aberrant Results – Handling Out of Specification, OOS, and Out of Trend, OOT results (Pre-Conference, 23 November )

The established topics will also be covered at PharmaLab 2026 from 23-25 November in Darmstadt – providing participants with the opportunity to exchange knowledge and experiences with representatives from authorities, industrial experts and scientists from laboratories:

  • Analytical Procedure Lifecycle Management (APLM)
  • GMP Compliance Trends Analytical Laboratories
  • Laboratory Optimization, Automation and Digitalization/Outsourcing in Pharmaceutical Laboratories
  • Endotoxin and Pyrogen Testing
  • Alternative and Rapid Microbiological Methods
  • Cell and Gene Therapies/ ATMPs – Quality and Safety
  • Bioassays/Potency Assays – Regulatory Requirements, Developments and Routine Use
  • Bioanalytical Control of Biological Drug Substances and Products
  • Quality Control of mRNA/LNP Products (Pre-Conference, 23 November)
  • 7th International Mycoplasma qPCR Testing User Day (Pre-Conference, 23 November)


Congress delegates benefit from 9 parallel conferences, 3 pre-conference workshops with altogether over 100 presentations, over 60 exhibitors in the exhibition and the networking event. An update in all relevant areas of pharmaceutical lab developments will be provided. We are also open for poster submissions for the exhibition.

One-day and multi-day tickets offer participants the opportunity to attend parts or even the entire congress and thereby put together an individual programme with the lectures of choice.

We look forward to welcoming you in Darmstadt at PharmaLab.

More information
Website: https://www.pharmalab-congress.com
eMail: info@concept-heidelberg.de