Secure collaboration and document management for API Biologics development20 May, 2022
The Active Product Ingredient (API) Biologics market is on a roll. APIs are defined as pharma products that have biologically active substances as components. The API biologics global market, which reached US$177.5 billion at the end of 2020, is projected to reach $265.3 billion by 2026. That’s a compound annual growth rate (CAGR) of 6.7 percent.
A number of factors are propelling growth in the API biologics market:
- Rising rates of chronic medical conditions, accelerated by urbanization and lifestyle changes
- Aging populations, with the population of those over 65 projected to double by 2050
- Patent expirations for branded APIs, creating opportunities for increases in generics, now forecast to a 7.4% CAGR for the coming seven years
- Pending approval of generic and blockbuster drugs that rely on APIs
- New generic versions of pharmaceutical company previously patented products
- Transition away from conventional manufacturing techniques
- Transition away from reliance on China for API development and pharmaceutical manufacturing, spurring increased investments in the U.S. and Europe
- Rising investment in drug discovery
- Accelerated use of genomic data, aided by artificial intelligence analysis
- Improvements in medical imaging
So, business is good, and the future looks bright. However, developing API biologics remains a long and complex process and, as a collaborative endeavor, is fraught with security concerns.
API development is a collaborative process.
API biologics development is characterized by three phases:
- Cell development, in which labs collaborate with Clinical Research Organizations (CROs) and remote technicians
- Product finalization, in which pharmaceutical companies collaborate with labs and experts in regulatory matters
- Product production, in which pharmaceutical companies collaborate with suppliers who fulfill the drug distribution pipeline.
The give-and-take of each phase involves collaboration among in-house teams, third-party experts, and product development partners. Even when development is outsourced to Contract Development and Manufacturing Companies (CDMOs) that provide a single source for lab, product development, and initial production, the CDMO’s invariably collaborate closely with the contracting organization, product pipeline partners, and regulators.
Efficient document management is critical to API development.
API Biologics development process entails extensive documentation. Not only are work-in-progress documents generated daily, but these and status reports must also be tagged by versions, which leads to large archives that must be easily searchable. At various points in the process, reports and presentations are produced for senior management, partners, investors, and government regulatory bodies.
Security risks are rising.
API biologics development and production, like all pharmaceuticals, must adhere to Federal Drug Administration (FDA) and Health Insurance Portability and Accountability Act (HIPAA) regulatory guidelines that protect patient privacy, and those regulations extend to documentation generated in the development process.
In today’s world, hackers are also a threat. The FDA now holds manufacturers accountable for security-related problems. Data shows that hackers target work-in-progress files and data and images used in developing AI machine learning. A successful hacker will implant malware, which can be followed by leaks of competitive information and costly ransom demands.
The ShareVault solution.
Fortunately, the API biologics industry can turn to a market-tested technology solution: ShareVault. ShareVault’s ultra-secure Virtual Deal Room (VDR) platform includes built-in software that speeds all aspects of collaborative development, including organizational tools, quick & easy set-up, document control, inter-document hyperlinking, and a powerful full-text search engine.
ShareVault’s VDR environment is perfect for a collaborative effort: it protects not only in-house team development, but also collaborations with third parties. ShareVault security extends to work-in-progress documents both locally and in the cloud allowing you to safely review and co-author documents with distributed teams. ShareVault is specifically prepped to share Electronic Trial Master Files (ETMF), Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Applications (BLA), Drug Master Files (DMF), Biologics Master Files (BMF), Emergency Use Authorizations (EUA), and other regulatory submissions.
Field-tested for API Biologics development.
ShareVault’s online platform has been selected by the Biotechnology Innovation Organization (BIO) and 40 other industry trade associations for their Business Solutions Program. ShareVault is now the leading virtual environment platform for API Biologics development and other Life Science applications:
- Diagnostics Development
- Therapeutics Development
- Medical Device Development
- Clinical Trials
- Product Development
- Regulatory Communications
- Partnering & Licensing
Focus on development, not document management and security!
The value of a great API development team is their ability to collaborate, create, test, and launch critical new medications. ShareVault’s VDR deal room allows a team to focus on that value, without cumbersome and time-consuming document processing or concerns about security.
Download the API Biologics Solutions Brief