BioConvergence LLC
BioConvergence LLC

Headquarters
Bloomington, Indiana ,USA

Location(s)
Bloomington, Indiana ,USA

Years in Drug Formulation
4 Years

Spokesperson
Alisa Wright, CEO

Web site 

Company's role in drug discovery and developmnet
BioConvergence LLC is a contract services firm specializing in product development services including: analytical, process and formulation development for small and large molecules. We help our clients research, create, and improve formulations such as solutions, emulsions, suspensions, and a specialization in lyophilized formulations.

Company's experience and expertise in drug formulation
We can provide pre-formulation and formulation services for small and large molecules. Services include: pre-formulation (physiochemical evaluation and excipient selection) and formulation (unit formula determination, container/closure selection, aseptic processing methods), process development (scale-up and process compatibility studies), and stability (ICH) for our clients. We can then create clinical materials for toxicology studies and clinical studies.

Relationship with pharma companies
BioConvergence is a pure play contract services provider. We help our clients develop and improve their formulations with quality and speed, so that our clients can be preparing for clinical manufacturing.

Factors critical for drug formulation
With regard to protein and other large molecule formulations, key factors in development are maintaining drug stability, aggregation, extractables/leachables, optimization of pH, salts, and drug concentration. We have expertise in identification of the factors in these key areas and optimization of formulations to prevent these factors from occurring or proliferating. We also perform stability studies to evaluate impurities, limit oxidation, aggregation, and potency.

Scientific/business/regulatory trends impacting drug formulation
A large increase in the advancement of large molecules through the pipeline has greatly impacted the formulation development area. Many trained research scientists have less experience with large molecule development and the challenges they create. Aggregation of proteins in particular is a very difficult problem for development staff and the equipment to detect and rectify aggregation is more sophisticated today. Training has become more and more important as well to fill the pipeline with scientists with large molecule expertise.

With the recent credit crisis in the US and overseas, speed to market has become even more important for biotech and pharmaceutical firms. The availability of funding to perfect formulations at the earliest stages is becoming more scarce, and reaching designate milestones can make or break the advancement of compounds in the short term. It is more important than ever to quickly formulate compounds to provide clinical materials in phase 0-1 to save time and money. It is becoming more the norm to optimize formulations as we move forward into later phases. Additionally, the growth in stable lyophilized formulations has driven the growth of contract services firms with expertise in this area as less scientific talent is available with experience in lyo development.

Success story
We have had multiple clients come to BioConvergence with lyo cycles of 100-120 hours as they approach the later clinical phases. These large cycle times greatly increase the costs of manufacturing as products close in on market release. Optimization of cycles is something that we have been able to work with our clients to perfect over the past few years. A recent client had a large molecule with over 120 hour cycle time. By working with some new excipient formulas, we were able to raise the glass transition temperature significantly resulting in a savings in cycle time of over 50%. This optimization saved our client time and cost immediately for manufacturing their materials for later clinical trials not to mention future commercial scale operations savings.

How will roles of CROs and contract manufacturers change over the next few years?
With the state of the economy, it is becoming more important for biotech and pharma firms to save every penny as they work to get products into the clinic. Contract services firms will be even more important over the next 2-3 years and it is our mission to make sure we can respond to our clients’ deadlines and needs.